Mark D. Stegall, M.D.

The purpose of this study is to collect and share detailed clinical data from all kidney transplant recipients from 7 kidney transplant centers (Mayo Clinic, Rochester, MN; Mayo Clinic, Scottsdale, AZ; Mayo Clinic, Jacksonville, FL; Cornell University, New York, NY; University of Michigan, Ann Arbor, MI; Henry Ford, Detroit, MI; University of Pittsburgh Medical Center, Pittsburg, PA) to retrospectively and prospectively study kidney transplant recipients.

The purpose of this study is to determine if “booster” revaccination with the Janssen Ad26.CoV2.S vaccine (JNJ-78436735, aka the J&J vaccine, a viral vector vaccine) increases anti-COVID spike protein antibody levels in solid organ transplant recipients who did not form acceptable levels of anti-COVID spike protein antibody after receiving two doses of a mRNA vaccine: Pfizer-BioNTech (BNT162b2 vaccine) or Modena (mRNA-1273). 

The purpose of this study is to evaluate if TCD601 can induce allogeneic tolerance in living donor renal transplant recipients

The aim of this study is to determine the validity of two tests on bone marrow of sensitized kidney transplant recipients in order to better understand why these patients with antibodies against their donors are at a greater risk of rejection of their transplanted organs.

The objectives of this study are to retrospectively assess detailed post-transplant outcomes in a large cohort of patients across 3 sites with a specific emphasis on the outcomes of Hispanics and American Indians compared to non-white Hispanics, to develop and implement a questionnaire to assess socioeconomic risk factors in transplant patients (including a cohort of Hispanics and American Indians), and to perform genetic studies (high-resolution HLA typing and whole genome sequencing studies) to identify genes associated with transplant outcomes (diabetes, rejection and graft loss) in Hispanics and American Indians.  

The purpose of this study is to investigate how efficiently the study medication imlifidase reduces the amount of donor specific antibodies (DSA) in comparison with plasma exchange (PE) therapy, in patients who have an active antibody mediated rejection (AMR) after recently been kidney transplanted. The purpose is also to investigate and compare safety for these two treatments. 20 patients will be treated with imlifidase and 10 with PE.

The purpose of this study is to evaluate the utility of using anti-HLA antibody titer to measure the effectiveness of antibody lowering therapy (i.e., desensitization) in highly-sensitized kidney transplant candidates.

The purpose of this study is to determine the safety of Mycophenolate Mofetil withdrawl in kidney transplant recipients aged 55 years or older at the time of transplantation compared to standard of care. MMF will be withdrawn by 10 months after kidney trasnplantation with all patients followed for 24 months. 

The objectives of this study are to retrospectively assess detailed post-transplant outcomes in a large cohort of patients across 3 sites with a specific emphasis on the outcomes of Hispanics and American Indians compared to non-white Hispanics, to develop and implement a questionnaire to assess socioeconomic risk factors in transplant patients (including a cohort of Hispanics and American Indians), and to perform genetic studies (high-resolution HLA typing and whole genome sequencing studies) to identify genes associated with transplant outcomes (diabetes, rejection and graft loss) in Hispanics and American Indians.  

This is a double-blind, randomized-withdrawal, placebo-controlled study consisting of 2 treatment periods, and a post-treatment Follow-up Period during which retreatment is permitted if needed.

The purpose of this study is to form a database collection of pancreas transplant recipients, of a large enough size that further studies can be carried out. The data collected will be shared and received by all institutions.

The primary purpose of this study in Phase 1 is to characterize the safety and tolerability of isatuximab in kidney transplant candidates.  The primary purpose of this study in Phase 2 is to evaluate the effectiveness of isatuximab in desensitization of patients awaiting kidney transplantation.

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.

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.

The purpose of this study of obinutuzumab administered as intravenous (IV) infusion in adults with end stage renal disease is to assess the safety and tolerability of the regimen at week 24 of the desensitization phase and at week 28 post kidney transplantation. All participants will be monitored for a minimum of 12 months following the last obinutuzumab infusion.

The purpose of this study is to determine if “booster” revaccination with the Janssen Ad26.CoV2.S vaccine (JNJ-78436735, aka the J&J vaccine, a viral vector vaccine) increases anti-COVID spike protein antibody levels in solid organ transplant recipients who did not form acceptable levels of anti-COVID spike protein antibody after receiving two doses of a mRNA vaccine: Pfizer-BioNTech (BNT162b2 vaccine) or Modena (mRNA-1273). 

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.

To evaluate the efficacy of Cinryze® given for the treatment of acute antibody-mediated rejection (of renal allograft) (AMR) in kidney transplant recipients as measured by the proportion of subjects with new or worsening transplant glomerulopathy (TG) at 6 months after treatment initiation.

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.

The purpose of this trial is to determine the safety and efficacy of eculizumab in the prevention of antibody mediated rejection (AMR) in living donor kidney recipients requiring desensitization therapy.

The specific purpose of this study is to compare the characteristics of patients at Mayo Clinic Rochester who received a living donor kidney transplant here preemptively versus those who dialyzed either less than 1 year or more than 1 year. 

The purpose of this study is to test whether a dosing regimen of eculizumab in addition to standard posttransplant care in positive crossmatch deceased donor kidney transplant recipients will reduce the incidence of acute humoral rejection (AHR).

Patients included in this study will be those who have demonstrable anti-human leukocyte antigen (HLA) antibody specific for their deceased donor. It is our hypothesis that blockade of terminal complement activation with eculizumab at the time of transplant in combination with our current protocols will reduce the incidence of AHR in recipients of deceased donor kidney transplants who have anti-donor HLA antibody

The purpose of this study is to assess the safety and effectiveness of  eculizumab for the prevention of antibody-caused rejection in patients who are having a kidney transplant from a living donor with a different blood type than their own.

The purpose of this study is to evaluate 12-month kidney function in highly sensitized (cPRA ≥99.9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care.

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.

The primary purpose of this study is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.

The purpose of this study is to evaluate the long-term safety in patients previously treated with Medeor cellular immunotherapy products in a Medeor parent study.

The purpose of this study is to create a detailed immune profile of transplant patients and donors to determine what characteristics are associated with response to COVID vaccination.

Transplant recipients and donors who respond to immunization to COVID vaccine will have a different immunologic profile at basline than those who do not repspond.

We woudl like to create a detailed immune profile of Transplant patients and donors to determne what  characteristics are associated with response to the COVID vaccination.

The purpose of this study is to see if treating patients who have high levels of donor specific alloantibodies post-transplant with bortezomib might prevent the development of transplant glomerulopathy and preserve allograft function.

Researchers would like to see if it is possible to predict which transplanted kidneys will do better long term based on the gene expression within a kidney biopsy one year after transplant. Gene expression profiling is used to study the activity of genes. Each gene has an "on/off" switch that controls how they are expressed in a cell, as well as a "volume control" that increases or decreases the level of expression of a particular gene as necessary. Researchers want to see if the presence and abundance of certain transcripts in a kidney biopsy at one year after transplant can predict which kidneys will have reduced function over time.

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 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. 

The purpose of this study is to validate the use of a RNAseq-based peripheral blood assay in liver transplant recipients when correlated to liver biopsy results.

The purpose of this study is to to determine the safety and effectivness of a single dose of autologous polyTregs or darTregs in renal transplant recipients with subclinical inflammation (SCI) in the 6 month post‐transplant allograft protocol biopsy compared to control patients treated with CNI‐based immunosuppression.