Clinical Trials

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

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 better understand how the immune system reacts to kidney transplantation in individuals who are potentially at higher risk for rejection.

The purpose of this study is to evaluate how advancing stages of chronic kidney disease (CKD) may impact the hypothalamic-pituitary-gonadal axis,and how alterations in sex hormones and menstrual cycles correlate with changes in endothelial health and sexual function before and after transplant.

The objectives of this study are to establish the dynamic changes in iron metabolism and circulating iron-regulatory immune cells in kidney transplant infection, and to determine quantitative changes in tissue levels of hepcidin and iron-regulatory macrophages in transplant biopsy and compare pyelonephritis case with control.

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 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.

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 test the hypothesis that pregnancy post-transplant will increase the risk of adverse renal events (defined as acute rejection, reduction in GFR by 30%, new or worsening proteinuria, or graft-loss).  The risk will be increased in women with complications in pregnancy, such as preeclampsia or pre-term delivery. 

The purpose of this pilot study is to investigate whether contrast-enhanced ultrasound (CEUS) may help evaluate segmental differences in renal perfusion better than doppler ultrasound and thus help direct a biopsy to the most abnormal part of the renal cortex.

The purpose of this study is to determine the effectiveness of ultrasound elastography in prediction of renal allograft fibrosis.        

The investigators will evaluate a technology-enabled strategy designed to promote medication adherence, routinely monitor regimen use, and mobilize appropriate transplant center resources to respond early to kidney transplant recipients demonstrating inadequate adherence.

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 ...

The purpose of this study is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept for maintenance rejection suppression after kidney transplant.

The purpose of this study is to investigate whether clazakizumab (an anti-interleukin (IL)-6 monoclonal antibody (mAb)) may be beneficial for the treatment of CABMR in recipients of a kidney transplant by inhibiting the production of Donor Specific Antibodies (DSA) and re-shaping T cell alloimmune responses.

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 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 obtain knowledge of the viscoelastic material properties of the kidney in healthy individuals, patients with chronic kidney disease, and patients who have received a kidney transplant. The aim of the study is to evaluate if these properties are unique indicators of renal health.

The purpose of this study is to develop a digital droplet PCR-based method to quantitate ccfDNA., and to establish ranges of donor ccfDNA that correspond to rejection status.

The purpose of this study is to determine the usefulness of a pharmacist-led motivational interview intervention for transplant recipients, and to determine the acceptance and satisfaction of transplant patients with a pharmacist-led motivational interview intervention.

This study aims to understand the pharmacogenomics of Native American patients compared to Caucasians who are undergoing kidney transplant for treatment of kidney disease.

The main purpose of this study is to investigate pre-transplant risk factors and beliefs regarding weight gain in patients with a diagnosis of type 2 diabetes mellitus (T2DM) who have undergone a kidney transplant. The aim is to guide an understanding of the rationale behind weight gain and an exploration of potential preventative measures, ultimately resulting in recommendations for future patient-centered interventions at a Midwestern tertiary healthcare center. The research question follows the PICOT format: population, intervention, comparison, outcome, and time. The question of interest is: In adult patients ≥ 18 years of age with T2DM who received a kidney transplant ...

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.

This study aims to measure the percentage of time spent in hyperglycemia in patients on insulin therapy and evaluate diabetes related patient reported outcomes in kidney transplant recipients with type 2 diabetes. It also aimes to evaluate immunosuppression related patient reported outcomes in kidney transplant recipients with type 2 diabetes.

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 purpose of this study is to use renal and kidney plus pancreas transplant patient samples to validate both the clinical utility of the CMV scoring algorithm and develop a clinically useful scoring guide for the BK virus immune competence assay.

The purpose of this study to collect blood samples and data to assess the diagnostic capability of an updated version of the Prospera™ test.  The current standard of care for detection of rejection in renal allograft recipients is serum creatinine, often used in combination with other blood tests such as proteinuria. Natera has developed an assay called Prospera™ to detect the amount of donor-derived cell-free DNA (dd-cfDNA), which is a marker of kidney rejection.

The purpose of this study of posoleucel ALVR105 is to assess the safety and tolerability of posoleucel ALVR105 in kidney transplant recipients. The key secondary objective is to test the hypothesis that the administration of posoleucel ALVR105 to kidney transplant recipients with BK viremia will demonstrate superiority in suppressing BK viral load compared with placebo.

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 evaluate the efficacy of ASP0113 compared to placebo in reducing the incidence of cytomegalovirus (CMV) viremia in CMV-seronegative subjects receiving a kidney from a CMV-seropositive donor. This study will also evaluate the safety of ASP0113 in this patient population.

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.

American Indians (AI) have cultural, emotional, physical and religious variables that influence the patient’s perception about kidney transplantation and dialysis, some of which may lead to delays in completion of kidney transplant evaluation and kidney transplantation. The purpose of this study is to asses the patient's perceptions about the kidney transplant evaluation process at Mayo Clinic Arizona, assess the patient's attitudes and feelings about the process of kidney transplantation and how that influences their emotional, physical, cultural and religious well-being and determine the patient's attitude and experience with their dialysis.

The purpose of this study is to understand differences in quality of life across multiple domains in three distinct older populations: those on dialysis in the community setting, those wait-listed for kidney transplantation, and those who have successfully undergone kidney transplantation. 

The purpose of this study is to assess the effectiveness and safety of NPC-21 when administered prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seropositive donor.

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 aims of this study are to identify frailty trajectories and biomarkers of frailty after kidney transplantation. Subjects will be followed beginning immediately prior to kidney transplantation until 1 year after kidney transplantation. Frailty will be prospectively assessed using performance-based measures (Fried criteria and Short Physical Impairment Battery). The relationship between frailty measures and blood levels of promising candidate biomarkers will be analyzed.

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.

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.

There is a need to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had kidney transplant. Researchers will examine blood, urine, and tissue samples and try to identify genetic markers for certain conditions like rejection, response to therapy, and scarring of the kidney. By studying gene patterns, researchers hope to be able to diagnose these conditions earlier and improve kidney survival.

The purpose of this study is to evaluate the safety and effectiveness of the VERIS CMV Assay as an aid in the management of anti-CMV treatment for solid organ transplant patients by showing that virus levels are in agreement with the observed clinical status.

The purpose of this study is to determine if Eculizumab is safe and could be used to prevent delayed graft function following kidney transplantation.

This study aims to determine the potential barriers that contribute to fewer patients with Chronic Kidney Disease (CKD) being placed on the waiting list for a kidney transplant and that accomplished through evaluating:

This current study aims to evaluate the efficacy of engagement modules in assisting patients who are candidates for renal and liver transplantation make significant lifestyle modifications. With the help of the Center for Innovation (CFI), a smartphone app (Android and iOS compatible) has been created to assist in both educating and engaging patients to develop and maintain healthy lifestyle modifications. Our goal is to create a cost-effective, smartphone-based platform that serves to not only efficiently educate but to also verify competence and keep our patients engaged.

The purpose of this study is to measure and characterize specific immune cell abnormalities found in patients who have type 1 diabetes and may or may not be on the waiting list for either a pancreas alone or a pancreas and kidney transplant.

The purpose of this study is to see if certain pre-transplant markers are able to predict how the kidney will respond after a liver transplant.

The purpose of this study is to (i)assess glucose variability at pre specified time points after Pancreas Transplantation (ii) collect pre-specified serious adverse events after PT and in appropriate control groups (iii) assess mixed meal dynamics after pancreas transplantation.

The purpose of this trial is to evaluate the reduction in incidence and severity of delayed graft function when using QPI-1002 with kidney transplants from donors older than 45 years who have brain death.

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.

The purpose of this research is to to determine whether home-based cardiac rehabilitation (CR) is an effective intervention to improve decreased physical function in patients with varying levels of kidney function. We will determine if home-based CR improves frailty parameters and SPPB scores. We will also determine if home-based CR improves health-related quality of life (HRQOL), body composition, physical activity, and adverse outcomes, including hospitalizations and death.

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 compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of CMV disease in kidney transplant recipients who are CMV seropositive pretransplant and received antilymphocyte induction therapy.

The purpose of this study is to determine if patient satisfaction with a pharmacist-video visit is non-inferior to a face-to-face, in-clinic pharmacist visit. 

A Multicenter, Prospective, Double-Blind, Randomized, Placebo-Controlled, Phase 3 Study of ANG-3777 (formerly BB3) to Improve Graft Function and Reduce the Severity of Kidney Dysfunction or Delayed Graft Function Following Kidney Transplantation in Recipients of a Deceased Donor Kidney

This trial studies whether the nonavalent human papillomavirus vaccine given to adult women prior to kidney transplantation can help the body build and maintain an effective immune response during the post-transplant period when they receive immunosuppressive drugs to prevent transplant rejection. This study will help inform our scientific understanding about vaccine-induced immune responses among immunosuppressed individuals.

The purpose of this study is to validate an MRI method to detect renal fibrosis in patients after kidney transplantation (KT).

The purpose of this study is to to determine whether or not prior living kidney donors have an increased risk of bone fractures. The study will also determine bone structure and health in prior living donors as compared to matched controls.  

We will determine if living kidney donors are at increased risk of bone disease and fractures following kidney donation. This information will be valuable in informing future kidney donors of the risks of donation and in devising treatments, such as administration of vitamin D analogs like calcitriol, to ...

The purpose of this study is to create a group of blood and urine samples from Mayo Clinic patients being screened for the kidney donor program as well as to collect risk factor data through a questionnaire. The data, blood and urine samples will be used for future research of kidney diseases at Mayo Clinic and future research at Mayo Clinic to learn about, prevent, or treat other health problems.

Frailty is a condition characterized by slowness, weakness, low physical activity, wasting, and exhaustion. Frailty increases the risk for adverse outcomes following transplant such as increased length of stay in the hospital, mortality, or graft function. No interventions for frailty are known for patients with renal disease, but exercise programs like pulmonary rehabilitation have been effective in improving frailty in patients with other diseases, such as lung disease. The goal of this study is to test whether exercise will also improve frailty among patients who are waiting for a kidney transplant and who are considered frail or pre-frail.

Hypothesis: we hypothesize that the abundance and functions of Breg subsets in kidney transplant patients could be associated with transplant tolerance and rejection, including DSA-mediated kidney transplant rejection. In addition, oral corticosteroid treatment significantly alters the frequency and function of Breg subsets, which could lead altered clinical outcomes.

Aims, purpose, or objectives:
1. Investigate the frequency Bregs and their ability to express IL-10 along with other immune cells in the context of tolerance/rejection in kidney transplant patients.
we hypothesize that the abundance and functions of Breg subsets in kidney transplant patients could be associated with transplant tolerance and rejection, ...

To compare the efficacy of brincidofovir (BCV) to valganciclovir (vGCV) for the prevention of cytomegalovirus (CMV) disease in kidney transplant allograft recipients who are CMV seronegative pretransplant and received a kidney from a CMV seropositive donor.

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. 

Patients that need reconstruction or re-building of their urinary bladder are often limited to having a segment of their intestine used for that purpose. Using intestine is less than ideal as it is an absorptive, mucous producing tissue and placing this in constant contact with urine creates significant long term problems. In patients that require a kidney transplant and bladder reconstruction, this study seeks to use a bladder graft from a deceased donor rather than intestine.

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 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 conduct a clinical trial examining the preliminary effectiveness, feasibility, and acceptability of an exercise intervention on frailty after kidney transplantation (KT).

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 use urinary exosomes to non-invasively identify (protein biomarkers) various conditions affecting the renal transplant. 

The purpose of this study is to attempt to improve outcomes after kidney transplantation and to improve the safety of living kidney donation based upon variation in the apolipoprotein L1 gene (APOL1). Genes control what is inherited from a family, such as eye color or blood type. Variation in APOL1 can cause kidney disease. African Americans, Afro-Caribbeans, Hispanic Blacks, and Africans are more likely to have the APOL1 gene variants that cause kidney disease. APOLLO will test DNA from kidney donors and recipients of kidney transplants for APOL1 to determine effects on kidney transplant-related outcomes.

The purpose of this study will be to evaluate the effect of the US Health Resources and Services Administration (HRSA) program to reimburse lost wages on the decision of individuals to initiate evaluation for living organ donation.

The purpose of this study is to obtain valuable knowledge to rapidly promote the Hispanic Kidney Transplant Program (HKTP) as a novel approach for increasing living donor kidney transplants(LDKT) nationally in the Hispanic community.

The purpose of this study is to attempt to improve outcomes after kidney transplantation and to improve the safety of living kidney donation based upon variation in the apolipoprotein L1 gene (APOL1). Genes control what is inherited from a family, such as eye color or blood type. Variation in APOL1 can cause kidney disease. African Americans, Afro-Caribbeans, Hispanic Blacks, and Africans are more likely to have the APOL1 gene variants that cause kidney disease. APOLLO will test DNA from kidney donors and recipients of kidney transplants for APOL1 to determine effects on kidney transplant-related outcomes.

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 evaluate post-transplant clinical outcomes in receipients of kidney transplants who are undergoing TruGraf® and TRAC™ monitoring.

The purpose of this study is to determine the safety of the SARS-CoV-2 vaccination in patients listed for solid organ transplantation, including heart, lung, liver, kidney, and pancreas.

The purpose of this study is to determine if the Living Donor Assessment Tool (LDAT) is an effective tool to improve the psychosocial evaluation of potential live kidney and liver donors. The LDAT was developed by the living donation team at the Zweig Family Center for Living Donation at the Mount Sinai Recanati/Miller Transplantation Institute. It assesses important areas of the evaluation process such as motivation (reason) for donation, knowledge of living donation, support, relationship to organ recipient, feelings about donation, stability in life and psychiatric and addiction history and provides a score that can be used to measure the ...

The purpose of this study is to evaluate KidneyCare (AlloSure, AlloMap kidney and iBox) in patients with negative c4d microvascular inflammation (MVI) with or without Donor-Specific Antibodies (DSA) as compared to cohort with normal biopsies without DSA.

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 primary purpose of this study is to implement the Hispanic Kidney Transplant Program (HKTP) at two transplant centers by conducting a needs assessment of barriers and using a “learning collaborative” model to deliver HKTP protocols, scripts, and materials.

The purpose of this study is to analyze the effect of parity, menopause and reproductive lifespan on kidney structure and function.

The study will prospectively determine the clinical utility of CMV cell-mediated immunity using the Quantiferon test. The investigators will use the assay results to tailor the duration of CMV prophylaxis in solid organ transplant patients.

The purpose of this study is to find out if the size of a donor's remaining kidney or the microscopic appearance of a tissue biopsy from the donated kidney is predictive of long-term kidney function and overall health.

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 objectives of this study are to determine whether adequate blood volumes can be obtained with the Tasso+ device for anti-HLA antibody testing, to compare MFI levels from at-home collected capillary blood to venous blood, and to obtain user feedback and experiences from patients.

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 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 is to evaluate the clinical performance of the Aptima CMV Quant assay on the Panther system in ethylenediaminetetraacetic acid (EDTA) plasma samples from solid organ transplantation recipients (SOTR) and hematopoietic stem cell transplant recipients (HSCTR).

The purpose of this study is to evaluate safety and efficacy outcomes in renal transplant recipients in whom post-transplant care is managed using AlloSure®. AlloSure® is a non-invasive test to measure donor-derived cell-free DNA (dd-cfDNA). The AlloSure test is intended to assess the probability of allograft rejection in kidney transplant recipients with clinical suspicion of rejection and to inform clinical decision-making regarding the necessity of renal biopsy in such patients at least 2 weeks post-transplant in conjunction with standard clinical assessment. Amendment 1 (A1): Is an observational study to develop and validate the clinical use of KidneyCare®.

The purpose of this study is to determine the change in exercise capacity by comparing VO2 max results pre & post renal transplant.

The purpose of this study is to assess the feasibility and safety of delivering adipose mesenchymal stem cells (AMSCs) to kidney allografts.

The purpose of this study is to determine the incidence of biopsy proven acute rejections detected due to elevated dd-cfDNA independent of change in serum creatinine, to determine incidence of DeNovo Donor specific antibody (DSA) or increase in preexisting DSA’s in presence of elevated dd-cfDNA, and to determine the association of elevated dd-cfDNA with progression of chronic changes in surveillance biopsies.

The overall goal of this study is to determine the safety and feasibility of infusing adipose-derived mesenchymal stem cells directly into the artery of renal allografts with biopsy-proven rejection in order to reduce inflammation detected in the graft.   We contend that future studies will show that administering immunomodulatory cells directly into the allograft will be more effective and safer than the current approaches of delivering massive doses of systemic immunosuppression.

Study participation involves receiving mesenchymal stem cells (MSC), created from the adipose tissue (body fat) of a donor, and infused into the main artery of a transplanted ...

The purpose of this study is to determine the prevalence of genetic mutations of cancer in kidney transplant patients receiving care at Mayo Clinic Arizona.

The purpose of this study is to decrease the waiting time on the transplant list for patients who have high level of anti-HLA antibodies with ESRD and improve the patients and allograft survival after transplant.