Greeting

EDUCATION

Indiana University, Bloomington, IN, 1993-1997. B.S. biology, with minors in animal behavior and psychology, 1997. Dean's List final six semesters.

Wayne State University School of Medicine, Detroit, MI, 1999-2003. MD awarded May 2003.

University of Colorado Health Science Center, Internship, Internal Medicine. Department of Medicine, Denver, CO. June 2003 – June 2004.

University of Colorado Health Science Center, Residency, Internal Medicine. Department of Medicine, Denver, CO. June 2004 – June 2006. ABIM certified Internal Medicine

University of Colorado Denver, Fellowship, Nephrology. Division of Renal Diseases and Hypertension, Denver, CO. July 2006 –June 2009. ABIM certified Nephrology.

University of Colorado Denver, Fellowship, Transplant Nephrology. Division of Renal Diseases and Hypertension, Transplant Center, Denver, CO. July 2008 –June 2009. UNOS/AST/ASN transplant certified.

Academic Appointments and Affiliations:

Associate Professor / July 2015 - present

Division of Renal Diseases and Hypertension, University of Colorado Denver

Assistant Professor / September 2009 - June 2015

Division of Renal Diseases and Hypertension, University of Colorado Denver

Attending Physician / September 2009 - present         

University of Colorado Hospital, Aurora CO

Attending Physician / December 2008 - July 2012

Denver Health and Hospital, general and critical care Nephrology, Denver, CO

Hospital Affiliations:

St. Mary’s Hospital and Regional Medical Center, Grand Junction, CO   January 2012 - present

Poudre Valley Hospital, Fort Collins, CO / January 2012 - present

Parkview Medical Center, Pueblo, CO / January 2012 - present

Memorial Hospital, Colorado Springs, CO / January 2012-present

Professional and Administrative Positions

Interim Medical Director: Kidney and Pancreas Transplant Program, University of Colorado Hospital. Jan 2020-current

Medical director: Vascular Composite Allograft Program, University of Colorado Transplant Center. May 2019-current. Program currently in development.

Director: Incompatible Transplant and Paired Exchange Program, University of Colorado Transplant Center. Feb 2017-Current. Oversee and coordinate all clinical pathways for patients requiring desensitization and/or undergoing paired exchange

Director: University of Colorado Kidney Transplant Fellowship Program. 2012-current. Appointed AST director of clinical activities and fellowship requirements for second and third year renal fellows participating in the AST-certified kidney transplant fellowship at the University of Colorado, Denver.

Co-Director: Essentials Core Cardiovascular, Pulmonary, and Renal (CVPR) block for undergraduate medical education, course IDPT 5005. 2011-2018.

Director: University of Colorado Kidney Trasplant Desensitization Program. 2011-2017. Supervise the development and implementation of desensitization protocols for patients awaiting kidney transplant with high levels of sensitization to HLA antigens at the University of Colorado Hospital Transplant Center.

Director: Living Donor Advocate Project. 2013-2018. Supervise the initiation and implementation of the Living Donor Advocate Program at the University of Colorado Hospital Transplant Center, aiming to increase community awareness and involvement in living kidney donation.

Consultant: Alexion Pharmaceuticals, Cheshire, Connecticut. 2011-2018. Invited participant on four national advisory boards, providing clinical input and expertise on the diagnosis and management of atypical hemolytic uremic syndrome (aHUS) in collaboration with other experts in the field.

Honors and Awards

Fellow of the American Society of Transplantation, awarded May 2015

February 2011: Recipient of the “ATC Young Investigator Award” for excellence of abstract submitted to ATC 2011 meeting, selected for oral presentation

Fall 2008: Recipient of the American Society of Transplant travel grant for attendance to the Fellow Symposium on Transplant Medicine

November, 2006: Recipient of the American Society of Nephrology travel grant for attendance to the national ASN Kidney Week meeting.

Professional Organizations

International Society of Nephrology: 2012 - present.

American Society of Nephrology: 2006 - present. Current elected member, ASN Transplant Advisory Group

American Society of Transplantation: 2008 - present. Current elected member, AST Kidney and Pancreas Advisory Committee

American Medical Association: 2003 – present.

Committee and Service Responsibilities

Board of Managers: Transplant Nephrology Fellowship Training and Accreditation Program. 2020-current

AST Research Network Committee: 2020-current (3 yr term)

Transplant Nephrology Fellowship Training Accreditation Program (TNFTAP): June 2018 - current

Invited Review Committee member. Assist the AST in accrediting institutions that have developed programs to provide specialty transplant nephrology training

Chairman: AST Transplantation and Immunology Research Network (TIRN) Clinical Scientific Review Committee. Appointed June2017 - June 2018

Responsibilities include reviewing grant applications, assigning primary/secondary reviewers, leading committee review calls, participate in final grant ranking

AST TIRN Scientific Review Committee. Appointed 2016 for 2 year term. Review and grade submissions for AST TIRN grants

ASN transplant community. Founding member July 2016-current.

Transplant Advisory Group (TAG), American Society of Nephrology. Elected member, 2012-2015, re-invited for 2nd term 2015-2018. Provide direct input and feedback on transplant-related issues and areas of interest to the American Society of Nephrology (ASN) council, including areas of public policy, education, and collaboration. Specific projects include lead author on a joint publication between the ASN Hypertension Advisory Group and TAG and co-lead author on a TAG consensus opinion manuscript on living kidney donation.

Kidney and Pancreas Advisory Council (KPAC), American Society of Transplantation. Elected member, 2012-present.

Direct participation on a team providing advice to the AST Board of Directors, addressing policy and educational needs, and developing collaborations to advance the science and practice of kidney and pancreas transplantation. Specific projects have included review/revision of AST/ASN online Transplant Nephrology Core Curriculum Course, development of the KPAC strategic plan, preparations for national ATC meeting programs, co-developer of a collaborative AST/ASN kidney transplant educational proposal for community nephrologists, review and summary of newly drafted United Network for Organ Sharing (UNOS) public policy proposals.

Trainee and Young Faculty Community of Practice, American Society of Transplantation. Volunteer, 2012-current. Assist in networking and educational programs for emerging transplant physicians and scientists.

QI and Patient Safety Advisory Group, University of Colorado, Denver, Department of Medicine. Volunteer, 2012-2013. Assisted in the development of recurring department-wide multidisciplinary morbidity and mortality conferences.

National Kidney Foundation “Kidney Early Evaluation Program”. Volunteer, winter/spring/summer 2008-2009. Assisted with medical screening for kidney disease in the general population.

University of Colorado Hospital Medical Board, elected fellow representative, 2008-2009.

University of Colorado Hospital House Staff Association Executive Committee, fellow representative, Academic Year 2008.

Rapid Improvement Task Force, Denver Health Hospital, 2006. Worked with a multidisciplinary team to improve timeliness and efficiency of patient discharge process.

Orientation Board, University of Colorado, Denver, 2005-2006. Provided orientation and guidance for incoming Internal Medicine interns.

Licensure and Board Certification

State of Colorado Medical License: 5/1/2017 – current

State of Montana Medical License: 4/1/2014 - current

State of Kansas Medical License: 8/15/2014 – 6/30/2015

ABIM Board Certified Internal Medicine: 2008-2018

ABIM Board Certified Nephrology: 2009-current

AST/ASN Certified Transplant Nephrology: 2009-current

Review and referee work

• Expert Reviewer: American Journal of Kidney Disease 2019-current
• Invited reviewer: 2019 American Transplant Congress abstracts
• Invited reviewer: 2018 American Society of Nephrology annual meeting abstracts
• Invited reviewer: 2018 American Transplant Congress abstracts
• Expert reviewer: American Journal of Transplantation, January 2017-current
• Expert reviewer: PLoS One, November 2016-current
• Expert reviewer: Clinical Transplantation, July 2016-current
• Invited reviewer: 2017 American Transplant Congress abstracts, Desensitization category.
• Expert reviewer, Kidney International, July 2016-current
• Expert reviewer, Transplantation, December 2015-current
• Invited reviewer: 2016 American Transplant Congress abstracts, Desensitization category.
• Invited moderator: 2014 American Transplant Congress/World Transplant Congress international meeting. Session title “Kidney: Living Donor”, July 2014.
• Invited reviewer: 2014 American Transplant Congress/World Transplant Congress abstracts for 2014 international meeting, “Living Donor” category.
• Expert reviewer: Clinical Journal of the American Society of Nephrology, December 2014-current.
• Expert reviewer: New England Journal of Medicine, July 2014-current.
• Expert reviewer: Transplant International, December 2013-current.
• Expert reviewer, American Journal of Nephrology, August 2013-current.
• Invited moderator: Controversies in Transplantation annual conference. Session title “New Challenges in Renal Transplant”, March 2012.
• Invited moderator: American Society of Nephrology Kidney Week national meeting. Session title “Renal Transplant AKI for the General Nephrologist”, November 2011.

Invited lectures and presentations

International

• Invited Speaker: Oxford/Ghent Dialysis and Transplantation Summer School Program; “Immunosuppression in 2015” and “Acute Transplant Dysfunction” September 2015
• Invited Speaker: Oxford University Nephrology Faculty Conference; “Clinical Significance of Low Level Pre-Transplant Donor Specific Antibodies” September 2015
• Invited Speaker and Session Leader: International Society of Nephrology endorsed “Basic Kidney Transplantation and Pathology Workshop”, Khartoum, Sudan, December 2014
• Invited speaker: International Society of Nephrology CME sponsored Contemporary Medicine, Public Health, and Nephrology conference, Saratov, Russia: “Cardiovascular Complications after Kidney Transplantation”, October 2012.
• Invited speaker: International Society of Nephrology CME sponsored Contemporary Medicine, Public Health, and Nephrology conference, Saratov, Russia: “Diagnosis and Treatment of AKI in the Kidney Transplant Recipient”, October 2012.
• Invited speaker: International Society of Nephrology CME sponsored 6th CME meeting in Nephrology and RRT, Minsk, Belarus: “Cardiovascular Complications after Kidney Transplantation”, October 2012.
• Invited speaker: International Society of Nephrology CME sponsored 6th CME meeting in Nephrology and RRT, Minsk, Belarus: “Diagnosis and Treatment of AKI in the Kidney Transplant Recipient”, October 2012.
• Invited speaker: 25th Clinical Histocompatibility Workshop, Honolulu, Hawaii: “Clinical Significance of De Novo Donor Specific Antibody Production Following Kidney Transplantation”. March, 2012
• Invited speaker, Oxford University Nephrology Faculty Conference, Oxford, UK: “Donor Specific Antibodies Before and After Kidney Transplantation”, October 2012.

National

• Invited Speaker: American Society of Nephrology Kidney Week Pre-Meeting Symposia, “Banff Classification: The Essentials” November 2020
• Invited Speaker: American Society of Nephrology Kidney Week Pre-Meeting Symposia, “Acute Rejection: Case-Based Treatment and Histology” November 2020
• Invited Speaker: American Society of Nephrology Kidney Week Pre-Meeting Symposia, “Acute Antibody Mediated Rejection” November 2019
• Invited Speaker: American Transplant Congress pre-meeting symposia, national 2019 meeting. Session: Beyond the Basics of A B and DR. Title: Reviewing Available Data on Clinical Outcomes. June 2019.
• Invited Speaker: American Society of Nephrology Kidney Week Pre-Meeting Symposia, “Acute Antibody Mediated Rejection” November 2018
• Invited Speaker: Renal Disease and Electrolyte Conference, Aspen, CO. “Surveillance DSA for the General Nephrologist” July 2018
• Invited Speaker: Renal Disease and Electrolyte Conference, Aspen, CO. “Kidney Transplant Year in Review 2017-2018” July 2018
• Invited Speaker: American Society of Nephrology Kidney Week Educational Session “Post-Transplant Monitoring: Beyond Serum Creatinine” presenting topic “Surveillance DSAs: Useful or Not?” November 2017
• Invited Speaker: American Society of Nephrology Kidney Week Pre-Meeting Symposia, “Acute Antibody Mediated Rejection” November 2017
• Invited Speaker: American Society of Nephrology Kidney Week Pre-Meeting Symposia, “Acute Antibody Mediated Rejection” November 2016
• Invited Speaker: Renal Disease and Electrolyte Conference, Aspen, CO. “Kidney Transplant Year in Review 2015-2016” July 2016
• Invited Speaker: American Society of Nephrology Kidney Week Pre-Meeting Symposia, “Acute Antibody Mediated Rejection” November 2015
• Invited Speaker: American Society for Histocompatibility and Immunogenetics national meeting, Denver, Colorado: “A Nephrologist’s Perspective – the Need for Caution with DSA”, October 2014.
• Invited speaker: Renal Disease and Electrolyte Disorder Conference, Aspen, CO. “Acid, Base, and Electrolyte Disorders in the Transplant Setting”, July 2013.
• Invited speaker: Renal Disease and Electrolyte Disorder Conference, Aspen, CO. “Kidney Transplant Literature Year in Review 2012-2013”, July 2013.
• Invited speaker: Alexion Pharmaceuticals Expert Presenters Program, webinar. “Prophylactic Eculizumab for Patients with Atypical Hemolytic Uremic Syndrome Undergoing Renal Transplantation”, November 2012.
• Invited speaker: Renal Disease and Electrolyte Disorder Conference, Aspen, CO. “Transplanting the Highly Sensitized Patient”, July 2011.
• Invited speaker: Renal Disease and Electrolyte Disorder Conference, Aspen, CO. “Kidney Transplant Literature Year in Review 2010-2011”, July 2011.
• Invited speaker: Controversies in Transplantation Conference, Breckenridge, CO. “Renal Transplantation in Patients with Atypical HUS: Case Presentation”, March 2011.
• Invited speaker: Controversies in Transplantation Conference, Breckenridge, CO. “Protocol Biopsy in Renal Transplant Recipients”, March 2010.

Regional

• Invited Speaker: Colorado Transplant Nurses Society, Denver CO. “Preventing Antibody Mediated Rejection”. January 2020
• Invited Speaker: Advanced Concepts in Transplantation Symposium, Denver, CO. “Transplant Rejection and Treatment” October 2018
• Chairman and presenter, “Atypical HUS Case Discussion Regional Scientific Exchange Forum”, Tulsa, OK, August 2015
• Invited speaker: Colorado Transplant Nurses Society. “Viral Infections in Kidney Transplant Recipients”, July 2014.
• Co-chairman and presenter: regional Thrombotic Microangiopathic Hemolytic Anemia Round Table Case Discussion, October 2013.
• Invited speaker: Colorado Center for Transplantation Care, Research and Education Lecture Series. “Antibody production before and after kidney transplant”, April 2012
• Invited speaker: ClinnImune Laboratories Continuing Education Program. “Clinical Significance of Pre-Transplant Donor Specific Antibodies”, April 2011.
• Invited speaker: Topics in Transplant Immunology Regional Meeting, Denver, CO. “Results of a Prospective Post-Kidney Transplant DSA Screening Protocol”, October 2010.

Departmental

Grand Rounds

• “Kidney Transplant Literature Year in Review 2017-2018,” September 2018
• “Kidney Transplant Literature Year in Review 2015-2016,” September 2016
• “Kidney Transplant Literature Year in Review 2010-2011,” September 2011
• “Novel Immunosuppression for Kidney Transplantation: What’s in the Pipeline?” April 2009
• “Looking for Subclinical Rejection, the Role of Protocol Biopsies in Kidney Transplantation,” January 2009
• “Timing of Renal Replacement Therapy Initiation in Acute Kidney Injury,” May 2008
• “Treatment of Proteinuria with Spironolactone,” April 2008
• “Obesity and Hypertension,” March 2007
• “Platelet Derived Growth Factor and Vascular Disease,” November 2006

Journal Clubs

• March 2017: “First Year Waitlist Hospitalization and Subsequent Waitlist and Transplant Outcomes” Lynch et al. AJT 2017; 17:1031-1041
• October 2015: “Capillary C4d and Kidney Allograft Outcome in Relation to Morphhologic Lesions Suggestive of Antibody-Mediated Rejection: Kikic et al. CJASN 10: 1435–1443, 2015
• April 2015: “A National Study of Outcomes among HIV-Infected Kidney Transplant Recipients” Locke et al. J Am Soc Nephrol 26: ccc–ccc, 2015
• March 2014: “Risk of End-Stage Kidney Disease Following Live Kidney Donation.” Muzaale et al. JAMA. 2014;311(6):579-586
• January 2012: “Specificity of Histological Markers of Long-Term CNI Nephrotoxicity in Kidney-Transplant Recipients Under Low Dose Cyclosporine Therapy.” Snanoudj et al. American Journal of Transplantation 201; 11: 2635-2646  
• March 2011: “Calculated PRA: The New Measure of Sensitization for Transplant Candidates.” Cecka et al. American Journal of Transplantation 2010; 10: 1–6  
• April 2009: “Conversion From Calcineurin Inhibitors to Sirolimus Maintenance Therapy in Renal Allograft Recipients: 24-Month Efficacy and Safety Results From the CONVERT Trial.” Schena et al. Transplantation 2009;87: 233–242
• December 2007: “Optimal Treatment of Obesity-Related Hypertension: the Hypertension-Obesity-Sibutramine (HOS) Study.” Sholze et al. Circulation. 2007;115:1991-1998.

University of Colorado Visiting Professor Preceptorship Lectures

• “Significance of Low Level Pre-Transplant Donor Specific Antibodies”, June 2015
• “Antibody-Mediated Rejection in Kidney Transplant Recipients”, June 2013
• “Pre-Transplant HLA Screening”, April 2012
• “Clinical Significance of Pre-Existing and De Novo Donor Specific Antibodies in Kidney Transplant Recipients”, November 2011
• “Malignancy After Kidney Transplant”, June 2011
• “Post-Transplant Monitoring for Donor Specific Antibodies”, November 2010

Teaching Record

Lectures

• First-year medical student Renal Pathophysiology course IDPT 5005: “Renal Transplantation.” May 2013 - current (annual).
• First-year medical student Renal Pathophysiology course IDPT 5005 small group facilitator. May 2007 – current (annual).
• Fourth-year medical student Interpretation of Clinical Laboratory Tests course IDPT 8030: “Sodium and Water Metabolism.” September 2010 - current (annual).
• Renal fellow core curriculum lecture series: “Kidney Transplantation: Basic Immunology and Pathophysiology.” April 2013 - current (annual). 1st, 2nd, and 3rd year renal fellows.
• First year renal fellow “Introduction to Kidney Transplantation” lecture. July 2014 - current (annual).
• Physician Assistant Lecture “Introduction to Inpatient Renal Transplant Management.” June 2013 – 2016 (annual).

Ward/Clinic Attending duties

• Supervision and bedside teaching of clinical nephrology and renal transplant fellows, inpatient transplant medicine wards, 2009-current. Topics include post-operative medical management of kidney transplant recipients, diagnosis and management of medical complications following kidney transplantation, supervision of renal transplant biopsy procedures, instruction and supervision of therapeutic plasma exchange and hemodialysis procedures, interpretation of kidney transplant pathology, medical management of renal and electrolyte disorders in liver transplant recipients.
• Supervision and bedside teaching of clinical nephrology and renal transplant fellows, outpatient kidney transplant clinic, 2009-current. Topics include medical management of outpatient kidney transplant recipients, diagnosis and management of medical complications following kidney transplantation, evaluation, management, and selection of potential kidney transplant recipients, evaluation and selection of potential living kidney donors.
• Supervision and bedside teaching of clinical nephrology fellows, inpatient nephrology consult service, 2009-current. Topics include diagnostic and management approach to patients with renal and electrolyte disorders, instruction and supervision of therapeutic plasma exchange and hemodialysis procedures.
• Renal Transplant Fellowship Training Program, 2009-current. Together with Drs. Chan and Wiseman, have trained 12 fellows in the subspecialty of Renal Transplantation. Currently Director of the training program (2012), currently primary mentor for Dr. Brigani Amante. 

Administrative Positions

• Director: University of Colorado Kidney Transplant Fellowship Program. 2012-current.  
• Co-Director: Essentials Core Cardiovascular, Pulmonary, and Renal (CVPR) block for undergraduate medical education, course IDPT 5005. 2011-2018. Organization, administration, supervision, and yearly revision of 30 basic renal physiology, pathology, pathophysiology, histology, and pharmacology lectures with associated small group sessions that comprise the renal sub-block of the CVPR course.
• Division Coordinator: Elective clinical renal rotation for interns, residents, 2010-2018. Organization, oversight and evaluation of house staff completing clinical nephrology rotations at the University of Colorado Hospital, Denver Health Medical Center, and the VA Medical Center.  
• Division Coordinator: Elective clinical renal rotation for medical students, course MEDS 8007. 2010-2018. Organization, oversight and evaluation of both resident and visiting medical students completing clinical nephrology rotations at the University of Colorado Hospital, Denver Health Medical Center, and the VA Medical Center.  
• Division Coordinator: Mentored Scholarly Activity (MSA) Program, 2011-current. Work with the MSA team to identify appropriate renal faculty members to mentor medical students based on the students’ scholarly interest as part of the required school of medicine longitudinal curriculum.
• Coordinator: Kidney Transplant Journal Club, 2010-current. Organization, supervision, and participation in monthly journal clubs encouraging discussion of recently published kidney transplant-related literature, with regular participation from renal attendings and fellows, pharmacists and pharmacy students, nurse coordinators, immunologists. 

Mentorship

• Primary research mentor for Dr. Adam Bregman, third year fellow, July 2018-currrent.
  • ATC 2019 poster presentation:
    • “Subclinical AMR in Stable Kidney Recipients with de novo DSA and Correlation with Donor Derived Cell Free DNA Testing”
• Primary research mentor for Dr. Scott Davis, second-year renal fellow, July 2015-June 2017.
  • ATC 2017 Oral abstracts:
    • “Tacrolimus Time in Therapeutic Range Predicts Adverse Clinical Outcomes in the First Year of Kidney Transplant”
    • “Lower Mean Tacrolimus Troughs Increase Risk of De Novo DSA in the First Year of Kidney Transplant”
      • Nominated for “Whats’s New and Hot in 2017” award
      • Travel grant received for outstanding abstract
      • ATC 2017 poster presentation:
        • “Mycophenolate Dose Reductions Are Not Associated with De Novo DSA”
        • ASN 2016 poster presentations:
          • “Acute Rejection is the Primary Determinant of Worse Kidney Allograft outcomes in Patients with De Novo Donor-Specific Antibodies”
          • “Change in De Novo Donor-Specific Antibody Intensity Predicts Allograft Dysfunction”
          • ATC 2016 poster presentation “Combined Effect of Acute Rejection and De Novo Donor-Specific Antibodies on Kidney Allograft Survival”
• Mentorship committee for James Dylewski MD, renal fellow July 2014-current. “The role of FcRn in Antigen Presentation by Glomerular Endothelial cells”
• Primary research mentor for Dr. Oluwafisayo Adebiyi, third-year renal fellow, June 2013-June 2015.
  • ASN 2014 oral presentation “Impact of Pre Transplant Donor Specific Antibodies in the Setting of a Negative Cell Based Flow Cytometry Cross Match on Graft Outcomes”
  • ASN 2014 poster presentation “Class, Timing, and Persistence of Pre transplant Donor Specific Antibodies (DSA) and Impact on Renal Allograft Outcomes”
  • WTC 2014 recipient of the Young Investigator Travel Award for excellence of abstract “Impact of Pre Transplant Donor Specific Antibodies in the Setting of a Negative Cell Based Flow Cytometry Cross Match on Graft Outcomes”
  • WTC 2014 oral presentation “Impact of Pre Transplant Donor Specific Antibodies in the Setting of a Negative Cell Based Flow Cytometry Cross Match on Graft Outcomes”
  • WTC 2014 oral presentaiton “Predictive Value of the Strength and Class of Pre Transplant Donor Specific Antibodies (DSA) on Clinical Outcomes in Renal Allograft Recipients”
  • WTC 2014 poster presentation “Timing and Persistence of Pre transplant Donor Specific Antibodies (DSA) and Impact on Renal Allograft Outcomes”
  • 2nd place for clinical oral abstract presentation, National Kidney Foundation Spring 2014 Young Investigator’s Forum, Las Vegas, NV, April 2014. “Pre-Transplant DSA with Negative Flow Cytometry has Minimal Impact on Graft Outcomes”
  • 2nd place for clinical oral abstract presentation, 12th Annual Nephrology Young Investigators Forum, 33rd Annual Advanced Nephrology Conference, San Diego, CA, January 2014. “Pre Transplant DSA and Renal Transplant Outcomes”
• Mentorship committee for Eric Stites, M.D., renal fellow 2014-current. “Microvesicles as a marker of antibody mediated rejection”
• Mentorship committee for Charles Le, M.D., renal fellow 2011-2013. “Influence of Early Acute Rejection on Graft Outcomes in the Adolescent-to-Young Adult Kidney Transplant Recipient”

Clinical Trials/Grant Support

• Principal Investigator: Vitaeris Inc. A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-Mediated Rejection in Kidney Transplant Recipients.
• Principal Investigator: Angion Biomedica. A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of BB3 to Reduce the Severity of Delayed Graft Function in Recipients of a Deceased Donor Kidney.
• Principle Investigator: Veloxis Pharmaceuticals. A Randomized Pilot Study of Treatment for Subclinical Antibody-Mediated Rejection in Kidney Transplant Recipients. $72,250
• Co-Principal Investigator: Quark Pharmaceuticals.A Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of QPI-1002 for Prevention of Delayed Graft Function in Recipients of a Donation After Brain Death Older Donor Kidney Transplant
• Principal Investigator: Shire Pharmaceuticals. A randomized double-blind placebo-controlled study to evaluate the efficacy and safety of Cinryze® for the treatment of acute antibody-mediated rejection in kidney transplant patients. Startup and budget pending.
• Principal Investigator: Alexion EVIDENCE study. Evaluation of Potential Predictors of Disease Progression in Patients With aHUS, Including Genetics, Biomarkers and Treatment. Ongoing.
• Co-Principal Investigator: ASTOUND trial (Astellas). Astagraf XL® to Understand the Impact of Immunosuppression on De Novo DSA Development and Chronic Immune Activation in Kidney Transplantation. Ongoing
• Principal Investigator: Angion Biomedica Corp.   Multicenter Pilot Study of BB3 to Improve Renal Function in Patients with Signs and Symptoms of Significant Renal Injury after Kidney Transplantation and at Risk for Dialysis. Completed 1/26/2015. $18,614.
• Principal Investigator: Octapharma. A prospective, global, multi-center, observational treatment registry study of intravenous immunoglobulin maintenance therapy in alloantibody positive renal allograft recipients. Ongoing. $91,480
• Principal Investigator: Alexion Pharmaceuticals. An Observational, Non-Interventional, Multi-Center, Multi-National Study of Patients with Atypical Hemolytic Uremic Syndrome (aHUS Registry) (Protocol M11-001). Ongoing. $45,500
• Principal Investigator: Tolera Therapeutics. A Two Part, Phase 1/2, Safety, PK, and PD Study of TOL101, an Anti-TCR Monoclonal Antibody for Prophylaxis of Acute Organ Rejection. Protocol TTI-121. Completed 4/23/2013. $181,030
• Co-Principal Investigator: Astellas. A Phase 2/3, Double-Blind, Placebo-Controlled, Two-Part Study (Part 1 Open-Label) to Assess the Safety, Efficacy, and Pharmacokinetics of Single Intravenous Doses of ASP8597 (Diannexin) in de novo Kidney Transplant Recipients (8597-CL-0201). Completed 9/28/2013. $237,503
• Co-Principal Investigator: Quark. Controlled, Randomized, Prospective, Double-Blind, Multicenter, Phase I/II, Dose-Escalation Study of the Safety, PK, and Clinical Activity of I5NP for Prophylaxis of Delayed Graft Function in Patients Undergoing Deceased Donor Kidney Transplantation (Protocol: QRK.006). Completed 4/15/2014. $136,043

Bibliography

Peer Reviewed Manuscripts

Scott Davis, M.D.; Christopher Wiebe, M.D.; Kristen Campbell, M.S.; Cheri Anobile, Michael Aubrey, M.S., C.H.S.; Erik Stites, M.D.; Monica Grafals, M.D.; Elizabeth Pomfret, M.D., Ph.D.; Peter Nickerson, M.D.; and James E. Cooper, M.D “Adequate Tacrolimus Exposure Modulates the Impact of HLA Class II Molecular Mismatch: A Validation Study in an American Cohort.” Am J Transplant 2020, in press

Cooper JE. “Evaluation and Management of Acute Rejection in Kidney Transplant”. Clin J Am Soc Nephrol 2020, in press

Lindsay M. Dyer-Kindy MS, PA-C, Alicia A. Heelan Gladden MD, MS, Jane Gralla PhD, Nicole D. McCormick DNP, NP-C, Colin Jenks BA, James Cooper MD, Peter T. Kennealey MD. “Bovine Carotid Artery Grafts for Hemodialysis Access do not Affect HLA Sensitization”. Hemodial Int. 2019 Nov 7 epub ahead of print

Davis S, Cooper JE. “No Time to Wait: Optimizing Use of Deceased Donor Kidneys”. Clin J Am Soc Nephrol November 2019, 14 (11) 1560-1561

Davis S, Gralla J, Klem P, Stites E, Wiseman A, Cooper JE. “Tacrolimus Intra-Patient Variability, Time in Therapeutic Range, and Risk of De Novo Donor Specific Antibodies” Transplantation 2019 Aug 9 Epub ahead of print

Cooper JE. “Desensitization in Kidney Transplant. A Risky (but necessary?) Endeavor for those with Limited Options”. Transplantation. 2019 Dec;103(12):2460-2461

Campbell KR, Juarez-Colunga E, Grunwald GK, Cooper J, Davis S, Gralla J. “Comparison of a time-varying covariate model and a joint model of time-to-event outcomes in the presence of measurement error and interval censoring: application to kidney transplantation” BMC Med Res Methodol. 2019 Jun 26;19(1):130

Diana Jalal, MD; Brandon Renner, MS; Jennifer Laskowski, BS; Erik Stites, MD; James Cooper, MD; Karissa Valente, BA; Zhiying You, PhD; Loni Perrenoud, BS; Moglie Le Quintrec, MD, PhD; Ismaeel Muhamed, PhD; Uwe Christians, PhD; Jelena Klawitter, PhD; Margaret A. Lindorfer, PhD; Ronald P. Taylor, PhD; V. Michael Holers, MD; Joshua M. Thurman, MD. “Endothelial Microparticles and Systemic Complement Activation in Patients With Chronic Kidney Disease”. J Am Heart Assoc. 2018 Jul 13;7(14)

Scott Davis, MD; Jane Gralla, PhD; Patrick Klem, PharmD; Suhong Tong, MS; Gina Wedermyer, CHS; Brian Freed, PhD; Alexander Wiseman, MD; and James E. Cooper, MD. “Lower Tacrolimus Exposure and Time in Therapeutic Range Increase the Risk of De Novo Donor-Specific Antibodies in the First Year of Kidney Transplantation.” Am J Transplant. 2018 Apr;18(4):907-915

Mithani Z, Gralla J, Adebiyi O, Klem P, Cooper JE, Wiseman AC. “De Novo Donor-Specific Antibody Formation in Tacrolimus-Based, Mycophenolate Versus Mammalian Target of Rapamycin Immunosuppressive Regimens.” Exp Clin Transplant. 2017 Mar 22. Epub ahead of print.

Davis S, Cooper JE. “Acute antibody-mediated rejection in kidney transplant recipients.” Transplant Rev (Orlando). 2017 Jan;31(1):47-54

Adebiyi OO, Gralla J, Klem P, Freed B, Davis S, Wiseman AC, Cooper JE. “Clinical Significance of Pretransplant Donor-Specific Antibodies in the Setting of Negative Cell-Based Flow Cytometry Crossmatching in Kidney Transplant Recipients.” Am J Transplant. 2016 Dec;16(12):3458-3467.

Shah P, Cooper JE, Lucia MS, Boils C, Larsen CP, Wiseman AC. “APOL1 Polymorphisms in a Deceased Donor and Early Presentation of Collapsing Glomerulopathy and Focal Segmental Glomerulosclerosis in Two Recipients.” Am J Transplant. 2016 Feb 5.

Weir MR, Burgess ED, Cooper JE, Fenves AZ, Goldsmith D, McKay D, Mehrotra A, Mitsnefes MM, Sica DA, Taler SJ. “Assessment and Management of Hypertension in Transplant Patients.” J Am Soc Nephrol. 2015; Jun;26(6):1248-60

Gralla J, Le CN, Cooper JE, Wiseman AC. “The Risk of Acute Rejection and the Influence of Induction Agents in Lower-Risk African American Kidney Transplant Recipients Receiving Modern Immunosuppression.” Clin Transplant. 2014 Mar;28(3):292-8

Javier Alfonso, Jane Gralla, Patrick Klem, Laurence Chan, Alexander C. Wiseman, James E. Cooper. “High-Dose Intravenous Immunoglobulin Therapy for Donor Specific Antibodies in Kidney Transplant Recipients with Acute and Chronic Graft Dysfunction: Updates on Previously Reported Cohorts.” Clinical Transplants, 2014.

Cooper JE, Gralla J, Klem P, Chan L, Wiseman AC. “Post-Transplant High Dose IVIG for De Novo Donor Specific Antibodies in Kidney Transplant Recipients with Graft Dysfunction.” Transplantation 2014;97: 1253-1259

Cooper JE, Gralla J, Adebiyi O, Wiseman AC, Chan L. “Donor Specific Antibodies Before and After Kidney Transplant: The University of Colorado Experience.” Clin Transpl. 2013:407-12

Le CN, Gralla J, Cooper JE, Wiseman AC. “The Risk of Acute Rejection and the Influence of Induction Agents in Low-Risk African American Kidney Transplant Recipients Receiving Modern Immunosuppression.” Clin Transplant, 2014 Mar;28(3):292-8

Brandon Renner, Jelena Klawitter, Ryan Goldberg, James W. McCullough, Viviana P. Ferreira, James E. Cooper, Uwe Christians, and Joshua M. Thurman. “Cyclosporine Induces Endothelial Cell Release of Complement-Activating Microparticles”. J Am Soc Nephrol. 2013 Nov;24(11):1849-62

Cooper JE, Wiseman AC. “AKI in Kidney Transplantation” Current Opinion in Nephrology and Hypertension. 2013 Nov;22(6):698-703.

Fuquay R, Cooper JE. “A Case of Cytomegalovirus-Induced Arthritis after Lymphocyte-Depleting Therapy for Kidney Allograft Rejection.” Open Journal of Nephrology, 2012, 2, 1-4

Cooper JE, Gralla J, Chan L, Wiseman AC. “Clinical Significance of Post Kidney Transplant De Novo DSA in Otherwise Stable Grafts.” In: Terasaki, P, ed. Clinical Transplants 2011. Los Angeles, UCLA Tissue Typing Laboratory, 2011: 359-364.

Cooper JE, Christians U, Wiseman AC. “Everolimus in Kidney Transplantation.” Transplant Research and Risk Management 2011:3 97–112

Cooper JE, Gralla J, Cagle L, Goldberg R, Chan L, Wiseman AC. “Inferior Kidney Allograft Outcomes in Patients with de novo Donor Specific Antibodies are Due to Acute Rejection Episodes.” Transplantation 2011;91: 1103–1109.

Cooper JE, Wiseman AC, Chan L. “Bortezomib Use in Chronic Antibody-Mediated Allograft Dysfunction: Updates and Additional Cases.” Clin Transpl. 2010:415-20.

Cooper JE, Huskey J, Chan L, Wiseman AC. “Preemptive Retransplant for BKV Nephropathy Without Concurrent Transplant Nephrectomy”. Transplantation. 2010 Aug 15;90(3):331-2.

Cooper JE, Wiseman AC. “Novel Immunosuppressive Agents in Kidney Transplantation”. Clinical Nephrology, Vol. 73 No. 5/2010 (333-343). Featured article

Cooper JE, Wiseman AC, Chan L. “Bortezomib use in chronic antibody-mediated allograft dysfunction: a report of three cases.” Clin Transpl. 2009:455-9.

Klem P, Cooper JE, Weiss AS, Gralla J, Owen P, Chan L, Wiseman AC. “Reduced Dose Rabbit Anti-Thymocyte Globulin for the Prevention of Acute Rejection in High Risk Kidney Transplant Recipient.” Transplantation 15;88(7):891-6, 2009

Nemenoff RA, Simpson PA, Furgeson SB, Kaplan-Albuquerque N, Crossno J, Garl PJ, Cooper JE, Weiser-Evans MC. “Targeted deletion of PTEN in smooth muscle cells results in vascular remodeling and recruitment of progenitor cells through induction of stromal cell-derived factor-1alpha.” Circ Res. 2008 May 9;102(9):1036-45.

Granneman JG, Zhai Y, Zhu Z, Bannon MJ, Burchett SA, Schmidt CJ, Andrade R, Cooper JE. “Molecular characterization of human and rat RGS 9L, a novel splice variant enriched in dopamine target regions, and chromosomal localization of the RGS 9 gene.” Mol Pharmacol. 1998 Oct;54(4):687-94.

Book Chapters

Wiseman AC, Davis S, Stites E, Cooper JE. “Preparing for Transplantation” Chronic Renal Disease, 2nd Edition. Rosenberg and Kimmel (Eds.) 2019 in press.

Adebiyi OO, Wiseman AC, Cooper JE. “Acute Graft Dysfunction” 2018. Scientific American Nephrology, Dialysis, and Transplantation. Riella and Singh (eds)

Wiseman AC, Cooper JE. “Prophylaxis and Treatment of Kidney Transplant Rejection.” 2017. Comprehensive Clinical Nephrology, Fifth Edition. Floege, Johnson, Feehally (Eds.).

Cooper JE, Chan L, Wiseman AC. “The Patient With a Kidney Transplant.” 2014. Manual of Nephrology, Eighth Edition. RW Schrier (Ed).

Wiseman AC, Cooper JE. “Prophylaxis and Treatment of Kidney Transplant Rejection.” 2014. Comprehensive Clinical Nephrology, Fifth Edition. Floege, Johnson, Feehally (Eds.).

Wiseman AC, Cooper JE. “Evaluation and Management of Graft Dysfunction.” 2014. Kidney Transplantation: A Practical Guide to Medical Management. Weir and Lerma (Eds.).

Wiseman AC, Cooper JE, Chan L. “Clinical Aspects of Renal Transplantation.” 2011. Diseases of the Kidney and Urinary Tract, 9th edition, RW Schrier (Ed.).

Cooper JE, Wiseman AC. “Optimizing Immunosuppression.” 2010. In Dianne McKay & Steven Steinberg, Kidney Transplantation, A guide to the Care of Kidney Transplant Recipients, Kidney Transplantation (pp 137-152). New York, NY: Springer.

Abstracts

ATC 2019: A Bregman, E stites, J Gralla, A Wiseman, J Cooper. “Subclinical Antibody Mediated Rejection in Kidney Transplant Recipients with de novo Donor Specific Antibodies and Correlation with Donor Derived Cell Free DNA Testing”

ATC 2018 oral abstract: S Davis, J Gralla, P Klem, A Wiseman, J Cooper. “Time in Therapeutic Range Predicts DSA Development and Acute Rejection in Kidney Recipients with High Tacrolimus Coefficient of Variation”

ATC 2017 oral abstract: S Davis, J Gralla, P Klem, A Wiseman, J Cooper. “Lower Mean Tacrolimus Troughs Increase Risk of De Novo DSA in the First Year of Kidney Transplant”

ATC 2017 oral abstract: S Davis, J Gralla, P Klem, A Wiseman, J Cooper. “Tacrolimus Time in Therapeutic Range Predicts Adverse Clinical Outcomes in the First Year of Kidney Transplant”

ATC 2017: S Davis, J Gralla, P Klem, A Wiseman, J Cooper. “Mycophenolate Dose Reductions Are Not Associated with De Novo DSA”

ATC 2017: P Klem, L Al-Omar, J Cooper, S Davis, J Gralla, D Choe, A Wiseman. “Low Dose Valganciclovir for CMV Prophylaxis in the First Year of Kidney Transplantation”

ATC 2017: P Klem, J Gralla, D Chang, A Wiseman, S Davis, J Cooper. “Antibiotic Prophylaxis Against Urinary Tract Infections after Renal Transplant”

ASN 2016: S Davis, J Gralla, A Wiseman, J Cooper. “Acute Rejection is the Primary Determinant of Worse Kidney Allograft outcomes in Patients with De Novo Donor-Specific Antibodies”

ASN 2016: S Davis, J Gralla, A Wiseman, J Cooper. “Change in De Novo Donor-Specific Antibody Intensity Predicts Allograft Dysfunction”

ATC 2016: S Davis, J Gralla, A Wiseman, J Cooper. “The Combined Effect of Acute Rejection and De Novo Donor-Specific Antibodies on Kidney Allograft Survival”.

ASN 2014 oral abstract: Oluwafisayo O. Adebiyi, MBBS, Jane Gralla, PHD, Alexander Wiseman, MD, Patrick Klem, Phar.D. and James Cooper, MD. “Impact of Pre Transplant Donor Specific Antibodies in the Setting of a Negative Cell Based Flow Cytometry Cross Match on Graft Outcomes.” J Am Soc Nephrol 24: 2014 pg. 40a

ASN 2014: Oluwafisayo O. Adebiyi, MBBS, Jane Gralla, PHD, Alexander Wiseman, MD, Patrick Klem, Phar.D. and James Cooper, MD. “Class, Timing and Persistence of Pre transplant Donor Specific Antibodies (DSA) and Impact on Renal Allograft Outcomes.” J Am Soc Nephrol 24: 2014 pg. 466a

WTC 2014 oral abstract: Oluwafisayo O. Adebiyi, MBBS, Jane Gralla, PHD, Alexander Wiseman, MD, Patrick Klem, Phar.D. and James Cooper, MD. “Impact of Pre Transplant Donor Specific Antibodies in the Setting of a Negative Cell Based Flow Cytometry Cross Match on Graft Outcomes.” Am J Trans Volume 14, Issue S3 pg. 123

WTC 2014 oral abstract: Oluwafisayo O. Adebiyi, MBBS, Jane Gralla, PHD, Alexander Wiseman, MD, Patrick Klem, Phar.D. and James Cooper, MD. “Predictive Value of the Strength and Class of Pre Transplant Donor Specific Antibodies (DSA) on Clinical Outcomes in Renal Allograft Recipients.” Am J Trans Volume 14, Issue S3 pg. 123

WTC 2014: Oluwafisayo O. Adebiyi, MBBS, Jane Gralla, PHD, Alexander Wiseman, MD, Patrick Klem, Phar.D. and James Cooper, MD. “Timing and Persistence of Pre transplant Donor Specific Antibodies (DSA) and Impact on Renal Allograft Outcomes.” Am J Trans Volume 14, Issue S3 pg. 562

WTC 2014: Adrienne Kercsak, Phar.D., Patrick Klem, Phar.D., Fawaz Al Ammary, MD, Victor Lewis, Phar.D., Marilyn E. Levi, MD, Ty Kiser, Phar.D. and James Cooper, MD. “The Effect of sulfamethoxazole/trimethoprim prophylaxis on early post-kidney transplant UTI.” Am J Trans Volume 14, Issue S3 pg. 123

WTC 2014: Zain Mithani, MD, Oluwafisayo Adebiyi, MD, Jane Gralla, PhD, Patrick Klem, Phar.D., James E Cooper, MD and Alexander C Wiseman, MD. “Donor Specific Antibody (DSA) Formation in Tacrolimus-Based, Mycophenolate vs mTOR Immunosuppression Regimens.” Am J Trans Volume 14, Issue S3 pg. 543

WTC 2014: Nicole Kelly, Phar.D., Jane Gralla, PhD, Victor Lewis, Phar.D., James E Cooper, MD, Oluwafisayo Adebiyi, MD, Patrick Klem, Phar.D. and Alexander C Wiseman, MD. “Clinical Outcomes Based on Everolimus Concentrations in Combination with Tacrolimus and Prednisone in Renal Transplant Recipients.” Am J Trans Volume 14, Issue S3 pg. 454

ASN 2013: James E. Cooper, MD, Jane Gralla, PhD, Patrick Klem, Phar.D., and Alexander C. Wiseman, MD. “Post-Transplant High Dose Intravenous Immunoglobulin (IVIG) Therapy for De Novo Donor Specific Antibodies in Kidney Transplant Recipients with Graft Dysfunction.” J Am Soc Nephrol 24: 2013 pg. 593a

ATC 2012: James E. Cooper, MD, Jane Gralla, PhD, Lawrence Chan, MD, PhD and Alexander C. Wiseman, MD. “Donor Specific Antibodies Detected by SAB Prior to Kidney Transplant Represent Minimal Risk Unless Associated with a Positive Cell-Based Flow Cytometry Cross-Match.” Am J Trans Volume 12, Issue Supplement s3 pg. 411

ATC 2011 oral abstract: James E. Cooper, MD, Jane Gralla, PhD, Linda Cagle, Lawrence Chan, MD, PhD and Alexander C. Wiseman, MD. “Inferior Graft Outcomes in Kidney Transplant Recipients with De Novo DSA are Due To High Antibody Titers and Prior Rejection Episodes.” Am J Trans Volume 11, Issue Supplement s2, pages 28–211, April 2011 pg. 191

ATC 2011 oral abstract: James E. Cooper, MD, Linda Cagle, Patrick Klem, Phar.D. and Alexander C. Wiseman, MD. “High Dose IVIG for Treatment of Persistent Post-Kidney Transplant DSA.” Am J Trans Volume 11, Issue Supplement s2, April 2011 pg. 192

ASN 2010 oral abstract: Cooper JE, Gralla J, Goldberg R, Chan L, Wiseman AC. “Results of a Prospective Screening Protocol for De Novo Donor-Specific Antibody Development after Kidney Transplant.” J Am Soc Nephrol 21: 2010 pg. 99a

ATC 2010 oral abstract: Cooper JE, Chan L, Wiseman AC. “Renal Allograft C4d Deposition in Recipients with DSA and Stable Graft Function.”   Am J Trans 2010, Vol 10:s4 pg 52

ATVB 2007: Seth B Furgeson, Peter A Simpson, Nihal Kaplan-Albuquerque, James Cooper, Raphael

Nemenoff, Mary C M Weiser-Evans. “PTEN Depletion Enhances Vascular Smooth Muscle Cell Proliferation and Accelerates Neointima Formation.” Arterioscler Thromb Vasc Biol. 2007;27:e35-e137 pg. e74

ATVB 2007: James E Cooper, Nihal Kaplan-Albuquerque, Mary C M Weiser-Evans, Raphael A Nemenoff. “Akt Isoforms Have Distinct Roles in Phenotypic Modulation of VSMC and

During Vascular Injury.” Arterioscler Thromb Vasc Biol. 2007;27:e35-e137 pg. e135