Martin L. Mai, M.D.

Closed for Enrollment

• A Phase 2, Prospective, Randomized, Multicenter, Open-Label, Controlled Trial to Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

  The purpose of this study is to compare the rate of progression from prediabetes at 4 months to frank diabetes at 12 months (as defined by increase in HbA1C or fasting BS to diabetic range based on the ADA criteria) after transplantation in kidney transplant recipients on Exenatide SR + SOC vs. standard-of-care alone.

  
   

• A Phase 3, Randomized, Multi-center, Open-label, Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy With MDR-101 for Induction of Immune Tolerance in Recipients of HLA-matched, Living Donor Kidney Transplants Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

  The primary objective of this study is to demonstrate the safety and efficacy of cellular immunotherapy with MDR-101 for induction of functional immune tolerance in recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.

• A Prospective, Observational, Multicenter, Open-Label, Pilot Study to Investigate Medication Adherence and Patient Reported Symptom Occurrence and Interference with Daily Life Comparing Once-Daily Envarsus XR® and Twice-Daily Immediate Release Tacrolimus in Adult Renal Transplant Recipients (SIMPLE) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to compare tacrolimus formulations (Envarsus XR® versus twice a day tacrolimus) with the hypothesis that Envarsus XR® improves transplant- and tacrolimus- associated symptoms when compared to a twice a day tacrolimus regimen.

• A Randomized, Controlled, Multi-center, Safety and Efficacy Study of FCR001 Cell-based Therapy Relative to a Tacrolimus and Mycophenolate-based Regimen in de Novo Living Donor Renal Transplant Recipients, and Safety in FCR001 Donors (FREEDOM-1) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to assess the safety, effectiveness, and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation.

• APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) (APOLLO) Jacksonville, Fla.

  Thirteen APOLLO Clinical Centers (CCs), or Networks, will prospectively enroll eligible living kidney donors and recipients of kidneys from eligible living and deceased kidney donors transplanted at all transplant programs in the continental United States including Puerto Rico. The APOLLO Scientific and Data Research Center (SDRC or Coordinating Center) will support and participate in studies determining the impact of donor and recipient APOL1 genotypes on kidney transplant outcomes in recipients of a kidney transplant from a donor with recent African ancestry, and follow African ancestry living kidney donors for changes in vital status, kidney function and proteinuria. APOLLO’s Study Chair and NIH Project Officers have broad expertise in disparities in kidney disease, transplantation, genetic factors and social components.

• Astagraf XL® to Understand the Impact of Immunosuppression on De Novo DSA Development and Chronic Immune Activation in Kidney Transplantation (ASTOUND) Scottsdale/Phoenix, Ariz., Rochester, Minn., Jacksonville, Fla.

  This study will compare the incidence of a two-part composite endpoint consisting of de novo donor specific antibody (DSA) formation or a designation of "immune activation" (IA) on peripheral blood molecular profiling in patients maintained on twice daily, immediate-release tacrolimus versus those maintained on Astagraf XL in the first two years post-transplant.

• Development and Validation of a Kidney Transplant-Specific Supplement for the Patient Experience with Treatment and Self- Management (PETS) Survey Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to evaluate how treatment and self-care after kidney transplant impacts people’s lives, relationships, and finances.

• The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Kidney Transplant Recipients – RNA-seq Signature Validation Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to validate the use of an RNA-seq based peripheral blood assay in renal transplant recipients in adult kidney transplant recipients.  

• The Together Project - Transplant Organ Genomics to Help Prevent Rejection in Kidney Transplant Recipients with Realtime Assay Monitoring Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

  The purpose of this study is to connect the findings of TruGraf (a peripheral blood RNA signature that has been shown to correlate with rejection in kidney transplants) with rejection episodes in kidney transplant patients that are managed using standard of care clinical protocols at the three Mayo transplant sites.