Clinical trials: Immunosuppression After Kidney Transplantation
Renal Transplant
Evaluation of Calcineurin-inhibitor Reduction With Conversion at 2 Months to Everolimus/Reduced Tacrolimus in Renal Transplant Recipients Following Campath® Induction
The purpose of this study is to evaluate whether conversion to everolimus (Zortress®), allowing the elimination or reduction of calcineurin inhibitors, will reduce nephrotoxicity (measured by increased creatinine clearance) and…
- Trial name
- NCT01935128
- Testing
- Arm 1 Everolimus/Reduced dose tacrolimus
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- University of Toledo Health Science Campus
Kidney Transplantation
A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based
The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.
- Trial name
- NCT01820572
- Testing
- Belatacept, Tacrolimus, Cyclosporine
- Where
- 117 sites in United States, Argentina and 8 more
- Volunteers
- 446 people
- Sponsor
- Bristol-Myers Squibb
Renal Transplantation
A Study Designed to Compare the Tolerability of an Increased Dose of Enteric-coated Mycophenolate Acid (MPA) in Renal Transplant Patients Whose Dose of Mycophenolate Mofetil (MMF) Was Reduced Due to Gastrointestinal Symptoms
To determine if conversion to enteric coated MPA allows an escalated dose of mycophenolic acid (MPA) to be tolerated in patients experiencing gastrointestinal (GI) symptoms
- Trial name
- NCT00658333
- Testing
- Enteric-coated Mycophenolate Acid (EC-MPA), Mycophenolate Mofetil (MMF)
- Where
- 37 sites in United States
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Pediatric Heart Transplantation, Immunosuppression
Tacrolimus/Everolimus vs. Tacrolimus/MMF in Pediatric Heart Transplant Recipients Using the MATE Score
The TEAMMATE Trial will enroll 210 pediatric heart transplant patients from 25 centers at 6 months post-transplant and follow each patient for 2.5 years.
- Conditions
- Pediatric Heart Transplantation, Immunosuppression, Chronic Kidney Diseases, Cardiac Allograft Vasculopathy
- Trial name
- TEAMMATE (NCT03386539)
- Testing
- Everolimus, Tacrolimus, Mycophenolate Mofetil
- Where
- 25 sites in United States
- Volunteers
- 211 people
- Sponsor
- Boston Children's Hospital
Kidney Failure
Everolimus Monotherapy as Immunosuppression After Liver Transplant
Tacrolimus is the standard immunosuppressive drug used to prevent organ rejection post liver transplant. One side effect of Tacrolimus is nephrotoxicity. Everolimus does not have the nephrotoxicity side effects of Tacrolimus.
- Trial name
- NCT04063865
- Testing
- Tacrolimus, Everolimus
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Indiana University
Renal Transplant Rejection
Randomized Conversion of Calcineurin-Inhibitors in Renal Allograft Recipients
This study is being done to investigate the impact of changing immunosuppressive medications from tacrolimus (Prograf®) to sirolimus (Rapamune®) between 6 and 24 months post transplant.
- Trial name
- NCT00866879
- Testing
- Sirolimus, Demographic Data, Medical History, and Donor Data, Blood Draws for Control Group
- Where
- United States
- Volunteers
- 275 people
- Sponsor
- Northwestern University
Kidney Failure
Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function
Tacrolimus is the standard immunosuppressive drug used to prevent organ rejection post liver transplant. One side effect of Tacrolimus is nephrotoxicity. Everolimus does not have the nephrotoxicity side effects of Tacrolimus.
- Trial name
- NCT04258423
- Testing
- Tacrolimus, Everolimus
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Indiana University
Stable Renal Transplant Recipients
Comparative Bioavailability of Myfenax® and CellCept® in Kidney Transplant Patients
The purpose of the study is to further investigate how much of the drug substance "mycophenolate mofetil" can be found in the blood of patients with kidney or renal transplants when treated with Myfenax® or CellCept®.
- Trial name
- NCT00991510
- Testing
- mycophenolate mofetil (Myfenax), mycophenolate mofetil (Cellcept)
- Volunteers
- 43 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
End-stage Renal Failure, Graft Rejection
Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
The current anti-rejection drug regime for kidney transplant recipients in use at the West London Renal \& Transplant Centre (WLRaTC) consists of induction therapy with the very potent monoclonal antibody Campath 1-H…
- Trial name
- TAESR (NCT00807144)
- Testing
- Tacrolimus (Kidney transplant maintenance immunosuppression), Kidney transplant maintenance immunosuppression
- Where
- United Kingdom
- Volunteers
- 102 people
- Sponsor
- Imperial College Healthcare NHS Trust
Kidney Transplantation
BMT and High Dose Post-Transplant Cyclophosphamide for Chimerism Induction and Renal Allograft Tolerance
The primary objective of this study is to assess the ability of bone marrow transplantation (BMT) and high-dose post-transplantation cyclophosphamide (PT/Cy) to induce renal allograft tolerance and thus enable discontinuation of…
- Trial name
- NCT02029638
- Testing
- anti-thymocyte globulin, Fludarabine, Cyclophosphamide
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Kidney Transplant
Renal Allograft Function and Histology Following Switching From A Tacrolimus to Sirolimus (SRL)-Based Immunosuppression-
The investigators hypothesize that Tacrolimus (Tac) withdrawal from a Tac, MMF and steroid based triple therapy regimen leads to long term improved/stabilized graft function (glomerular filtration rate, GFR) primarily as a…
- Trial name
- NCT01166724
- Testing
- Sirolimus, Tacrolimus
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- The Cleveland Clinic
Liver Transplantation
Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation
Most patients who get a liver transplant must take immunosuppressants for the rest of their lives. However, this has occurred at the expense of chronic CNI toxicity, e.g.
- Trial name
- NCT02736227
- Testing
- Tacrolimus Withdrawal and Everolimus Monotherapy
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Northwestern University
CNI Side Effects
Calcineurin Inhibitor Sparing After Kidney Transplantation
Reducing drug side effects is a key issue in transplantation. One class of drugs commonly used, calcineurin inhibitors (CNIs), is associated with negative side effects, namely, toxicity to the transplanted kidney.
- Trial name
- CNI-Sparing (NCT01062555)
- Testing
- Cyclosporine & Cellcept, Prograf & Cellcept, Low Dose CNI (Cyclosporine or FK) and Cellcept
- Where
- United States
- Volunteers
- 527 people
- Sponsor
- University of Minnesota
Kidney Transplantation
Regimen Optimization Study
Patients who undergo a kidney transplant require prolonged therapy with drugs that suppress the immune system (called immunosuppressive regimens) to stop the immune system from attacking the transplanted kidney in order to limit…
- Trial name
- NCT02137239
- Testing
- Thymoglobulin, Belatacept, mycophenolate mofetil(MMF)
- Where
- 20 sites in United States, Argentina
- Volunteers
- 58 people
- Sponsor
- Bristol-Myers Squibb
Atherosclerosis, Kidney Failure
Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients
The purpose of this study is to determine whether immunosuppression by tacrolimus, mycophenolate mofetil, and prednisone compared to conversion to sirolimus, mycophenolate mofetil, and prednisone affect the progression of…
- Trial name
- NCT00311311
- Testing
- tacrolimus, mycophenolate mofetil, prednisone
- Where
- 8 sites in United States, Canada
- Volunteers
- 72 people
- Sponsor
- Pfizer
Diabetes Mellitus, Adult-Onset
Optimum Immunosuppression in Renal Transplant Recipients.New Onset Diabetes After Transplantation
New onset diabetes after renal transplantation (NODAT) is a common and severe complication negatively influencing graft and patient survival. Cyclosporine (CsA) and Tacrolimus are the basis of modern immunosuppression.
- Trial name
- 01-DMPT (NCT01002339)
- Testing
- Tacrolimus with rapid steroid withdrawal, Tacrolimus with steroids minimization, CsA with steroid minimization
- Where
- 10 sites in Spain
- Volunteers
- 134 people
- Sponsor
- Armando Torres Ramírez
Kidney Transplantation
Everolimus in de Novo Kidney Transplant Recipients
The purpose of this study was to evaluate whether delayed (i.e. 28 ± 4 days post-transplant) administration of everolimus after transplantation reduces the risk of wound healing complications in comparison with immediate…
- Trial name
- NEVERWOUND (NCT01410448)
- Testing
- Everolimus, Mycophenolate sodium, Cyclosporine
- Where
- 22 sites in Italy
- Volunteers
- 383 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Bela 8 Week Dosing
The purpose of this study is to transition patients who have been stable on Belatacept for one year after kidney transplant from standard 4-week to an investigational 8-week belatacept dosing schedule.
- Trial name
- NCT02560558
- Testing
- Belatacept
- Where
- 2 sites in United States
- Volunteers
- 166 people
- Sponsor
- Emory University
Kidney Transplant Recipients, Liver Transplant Recipients
COVID Protection After Transplant-Immunosuppression Reduction
This study will enroll individuals who have: Completed primary series of mRNA COVID-19 vaccine, and An antibody response ≤ 2500 U/mL measured at least 30 days after the last dose of vaccine.
- Trial name
- CPAT-ISR (NCT05077254)
- Testing
- Pfizer-BioNTech COVID-19 Vaccine 2023-2024, Moderna COVID-19 Vaccine 2023-2024, SOC IS Regimen
- Where
- 15 sites in United States
- Volunteers
- 48 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Asses Immunosuppression Modulation on Renal Recovery Post LT
Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant
This is a study to help understand how well new combinations of immunosuppressive medications (medications that weaken your immune system to prevent your body from rejecting the transplanted liver) work compared to standard…
- Trial name
- NCT04104438
- Testing
- Basiliximab 20 MG
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Fady M Kaldas, M.D., F.A.C.S.