Clinical trials: Kidney Transplant Immunosuppression
Renal Transplantation
Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant
To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy
- Trial name
- NCT00148252
- Testing
- Mycophenolate mofetil withdrawal, Cyclosporione A withdrawal
- Where
- 9 sites in Norway
- Volunteers
- 298 people
- Sponsor
- University of Oslo School of Pharmacy
Renal Failure
Immunosuppressive Effects of Mycophenolate Mofetil and Valganciclovir in Kidney Transplant Recipients
Valganciclovir (VGCV) has recently been approved by the Food and Drug Administration (FDA) for the treatment and prevention of cytomegalovirus (CMV) retinitis in HIV patients.
- Trial name
- NCT00198224
- Testing
- phlebotomy
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Indiana University
End Stage Renal Disease, Rejection of Renal Transplant
Extended Release Tacrolimus vs. Twice-Daily Tacrolimus
The overall aim of the study is to prospectively investigate the impact of two maintenance calcineurin inhibitor immunosuppressive regimens: once-daily extended release tacrolimus and twice-daily tacrolimus on subpopulations of T…
- Trial name
- NCT03289650
- Testing
- Tacrolimus, Tacrolimus Extended Release Oral Tablet [Envarsus]
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Lorenzo Gallon
Kidney Diseases
Steroid Withdrawal in Pediatric Renal Transplant: Impact on Growth, Bone Metabolism and Acute Rejection
The present study investigates the safety and efficacy of steroid withdrawal at six days post-transplant in pediatric renal recipients under concomitant immunosuppression based on antibodies anti IL2 (interleukin 2), Tacrolimus…
- Trial name
- NCT00707759
- Testing
- Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone, Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone
- Where
- Chile
- Volunteers
- 28 people
- Sponsor
- Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
Kidney Transplant, Diabetes Mellitus, Type 2
Immunosuppression Impact on the Metabolic Control of Kidney Transplant With Pre-Existing Type 2 Diabetes (DM)
Protocol Title: Randomized open label study comparing the metabolic control of first Kidney Transplant recipients with Type 2 Diabetes Mellitus (DM) receiving either Prograf or Neoral as part of a ATG induction, prednisone free…
- Conditions
- Kidney Transplant, Diabetes Mellitus, Type 2, Diabetic Nephropathy
- Trial name
- NCT00296296
- Testing
- Cyclosporin, Tacrolimus, 'Diabetes Education / Management'
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Stanford University
Renal Transplant Rejection
Prospective Study Comparing Brand and Generic Immunosuppression on Transplant Outcomes, Adherence, & Immune Response in Kidney Transplant Recipients
As the patents for brand-name immunosuppressive medications expire, there is increasing interest in using generic immunosuppressive drugs.
- Trial name
- NCT02866682
- Testing
- Prograf, Tacrolimus
- Where
- United States
- Volunteers
- 176 people
- Sponsor
- University of California, Los Angeles
Intestine Transplantation, Kidney Transplantation
Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
Parts A \& B: Conversion of stable pediatric allograft recipients from Prograf® immunosuppression to Advagraf® immunosuppression to compare exposure and one year follow-up for safety and efficacy.
- Conditions
- Intestine Transplantation, Kidney Transplantation, Lung Transplantation, Liver Transplantation
- Trial name
- NCT01294020
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 16 sites in Belgium, Czechia and 5 more
- Volunteers
- 81 people
- Sponsor
- Astellas Pharma Europe Ltd.
Kidney Transplantation
Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients
This study will evaluate the efficacy and safety of AEB071 in preventing acute rejections after kidney transplantation, when combined with tacrolimus for the first 3 months and with myfortic thereafter.
- Trial name
- NCT00403416
- Testing
- AEB071, Mycophenolic Acid
- Where
- 28 sites in United States, Canada and 6 more
- Volunteers
- 215 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplantation
Influence of Sirolimus and MMF on Vascular Function and Markers of Cellular Function in Renal Transplant Recipients
Chronic transplant nephropathy and cardiovascular death are the main reasons for loss of transplanted organs after kidney transplantation.
- Trial name
- NCT00204321
- Testing
- sirolimus (drug), mmf (drug)
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- University Hospital Muenster
Kidney Transplantation
MMF, Daclizumab and Corticosteroids as Mainstay Immunosuppression in Renal Transplant Patients
To determine the renal function, as expressed by the glomerular filtration rate at 12 months, in renal transplant recipients receiving mycophenolate mofetil, daclizumab, and corticosteroids as mainstay immunosuppression in…
- Trial name
- NCT00231764
- Testing
- daclizumab
- Volunteers
- 1,760 people
- Sponsor
- Ekberg, Henrik, M.D.
Kidney Transplantation, Treatment Refusal
Survey of Adherence to Immunosuppression and Other Medications in Kidney Transplant Patients
Goal: To define the causes and issues associated with nonadherence in our population Hypothesis: There is a difference in the rates and patterns of adherence to transplant medications versus other medications also taken by…
- Conditions
- Kidney Transplantation, Treatment Refusal, Patient Compliance
- Trial name
- NCT00433134
- Testing
- Adherence
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- State University of New York - Downstate Medical Center
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
Kidney Transplantation
Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate…
- Trial name
- INTAC (NCT00113269)
- Testing
- basiliximab, rabbit anti-thymocyte globulin, tacrolimus
- Where
- 29 sites in United States
- Volunteers
- 501 people
- Sponsor
- Astellas Pharma Inc
Kidney Transplant, Immunosuppression
KidneyCare Immuno-optimization in Renal Allografts (KIRA)
This is an unblinded, randomized, four-arm interventional research study enrolling patients who are undergoing kidney transplantation.
- Conditions
- Kidney Transplant, Immunosuppression, Allograft
- Trial name
- NCT05423496
- Testing
- KidneyCare, steroid, MMF
- Sponsor
- CareDx
Kidney Transplantation
REgulatory T Cell Therapy to Achieve Immunosuppression REduction
The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor…
- Trial name
- RETIRE (NCT06552169)
- Testing
- Arm 1: SOC (mTOR + CNI), Arm 2A: TRACT/MONO mTOR, Arm 2B: TRACT/MONO CNI
- Where
- 7 sites in United States, Taiwan
- Volunteers
- 34 people
- Sponsor
- Singulera Therapeutics Inc.
Kidney Transplantation
rATG Versus rATG Combined With Intravenous Immunoglobulin (IVIG) Induction Immunosuppression in HLA Incompatible Transplantation (INHIBIT)
This study aims to prove similar efficacy of PE/rATG (intervention) and PE/rATG/IVIG (centre standard of care) induction regimens to prevent biopsy proven antibody-mediated changes and TCMR as composite endpoint within 12 months…
- Trial name
- INHIBIT (NCT04302805)
- Testing
- Privigen, Thymoglobulin, Plasma Exchange
- Where
- Czechia
- Volunteers
- 17 people
- Sponsor
- Institute for Clinical and Experimental Medicine
Renal Transplantation
Safety and Efficacy Study of Voclosporin and Tacrolimus in Transplantation
The purpose of this study is to demonstrate the efficacy and safety of voclosporin administered orally twice daily for the prevention of acute allograft rejection in recipients of a kidney transplant.
- Trial name
- INSPIRE (NCT01586845)
- Testing
- voclosporin, tacrolimus
- Sponsor
- Aurinia Pharmaceuticals Inc.
Kidney Failure, Chronic, Diabetic Nephropathies
Effects of Rituximab and Mycophenolate Mofetil (MMF) on Highly Sensitized Patients Awaiting Renal Transplant
This is a 12-month phase 2, prospective, open label study to evaluate the effect of rituximab with mycophenolate mofetil (MMF)on the PRA of 14 highly sensitized patients who just completed an 8 month trial of MMF treatment alone.
- Conditions
- Kidney Failure, Chronic, Diabetic Nephropathies, Glomerulonephritis, IGA, Hypertension, Renal
- Trial name
- NCT00446251
- Testing
- Rituximab, Mycophenolate mofetil (MMF)
- Volunteers
- 14 people
- Sponsor
- University of Washington
Immunosuppression
Once-daily Regimen With Envarsus® to Optimize Immunosuppression Management and Outcomes in Kidney Transplant Recipients
With the availability of well-studied once-daily formulations of tacrolimus, the ability to achieve a true once-daily immunosuppressant regimen along with everolimus and steroids may finally be achievable and have the potential…
- Trial name
- NCT02954198
- Testing
- Tacrolimus, Prednisone, Mycophenolate mofetil
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Medical University of South Carolina
Renal Transplant
24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients
The objective of the study is to compare the cardiovascular profile of an everolimus and mycophenolic acid immunosuppressive regimen with a calcineurin inhibitor and mycophenolic acid regimen in maintenance renal transplant…
- Trial name
- EVITA (NCT01169701)
- Testing
- Everolimus, Tacrolimus, Mycophenolic acid (MPA)
- Where
- 9 sites in Spain
- Volunteers
- 71 people
- Sponsor
- Novartis Pharmaceuticals