Clinical trials: Kidney Transplant Recipients
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
A Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen
The objective of this study is to observe and evaluate the change in renal function following conversion from cyclosporine-based immunosuppressive regimen to tacrolimus-based one.
- Trial name
- NCT02963103
- Testing
- Tacrolimus
- Where
- South Korea
- Volunteers
- 13 people
- Sponsor
- Astellas Pharma Korea, Inc.
Transplant Rejection
BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)
Primary Objectives: Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR Secondary Objectives: To assess the overall efficacy of BIVV020 in…
- Trial name
- NCT05156710
- Testing
- BIVV020 (SAR445088), Intravenous immunoglobulin (IVIg), Rituximab or biosimilar
- Where
- 27 sites in United States, Canada and 5 more
- Volunteers
- 48 people
- Sponsor
- Sanofi
Kidney Transplant, Immunosuppresion
Immunosuppression Optimization Using The Prospera Assay In Kidney Transplant Recipients (IMPAKT)
IMPAKT is a research study that looks at whether a blood test called Prospera™ can help doctors better adjust anti-rejection medications, compared to the usual way doctors manage these medications without using this test.
- Trial name
- IMPAKT (NCT07718633)
- Testing
- Prospera Immunosuppression Optimization
- Volunteers
- 750 people
- Sponsor
- Natera, Inc.
Kidney Transplantation
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
The purpose of the study in de novo renal transplant patients is to evaluate the effect on renal function of an optimized new regimen in comparison with the standard everolimus exposure plus a low-dose cyclosporine microemulsion…
- Trial name
- NCT00170885
- Testing
- Everolimus
- Where
- Switzerland
- Sponsor
- Novartis
Kidney Transplant
Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus in Kidney Transplant Recipients.
The purpose of this study is to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) in kidney transplant recipients.
- Trial name
- PK-TACT (NCT04102943)
- Testing
- tacrolimus tablet, tacrolimus capsules
- Where
- South Korea
- Volunteers
- 128 people
- Sponsor
- Chong Kun Dang Pharmaceutical
Liver Transplant, Kidney Transplant
A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
The purpose of this study is to evaluate the impact of Advagraf, prolonged-release, once daily tacrolimus formulation, on long-term graft survival in kidney and liver allograft recipients.
- Trial name
- ADDRESS (NCT02057484)
- Testing
- Tacrolimus
- Where
- 145 sites in Austria, Belarus and 22 more
- Volunteers
- 2,300 people
- Sponsor
- Astellas Pharma Europe Ltd.
Renal Transplantation
Safety, Tolerability and Efficacy of Everolimus With Lower Versus Higher Levels of Tacrolimus in de Novo Renal Transplant Patients
This study will assess the safety and efficacy of everolimus with basiliximab, corticosteroids and lower levels versus higher levels of tacrolimus in de novo renal transplant recipients.
- Trial name
- NCT00170833
- Testing
- Everolimus
- Volunteers
- 80 people
- Sponsor
- Novartis Pharmaceuticals
Liver Transplantation, Kidney Transplantation
A Study of Modigraf® (Tacrolimus Granules) to Evaluate the Pharmacokinetics and Long-term Safety and Efficacy in De Novo Pediatric Allograft Liver and Kidney Transplantation Recipients
The purpose of this study is to determine the pharmacokinetics of tacrolimus following oral administration of Modigraf, after the first oral dose and at steady state in pediatric participants undergoing de novo allograft liver or…
- Trial name
- NCT05152628
- Testing
- Tacrolimus granules
- Where
- 4 sites in China
- Volunteers
- 55 people
- Sponsor
- Astellas Pharma China, Inc.
Renal Transplant Recipients
Efficacy and Safety Study of the Switch From Cyclosporin to Tacrolimus in Renal Transplant Recipients
The objective of this study is to evaluate the effects of tacrolimus sustained-release capsules replacing cyclosporin on kidney function of renal transplant recipients.
- Trial name
- NCT02706678
- Testing
- Tacrolimus sustained-release capsule
- Where
- 9 sites in China
- Volunteers
- 105 people
- Sponsor
- Astellas Pharma China, Inc.
Renal Transplantation
Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients
The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.
- Trial name
- NCT00038948
- Testing
- Sirolimus, tacrolimus, Cyclosporine A
- Volunteers
- 830 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
de Novo Kidney Transplant Recipients, Renal Transplantation
Once-a-day Regimen With Everolimus, Low Dose Cyclosporine and Steroids in Comparison With Steroid Withdrawal or Twice a Day Regimen With Everolimus, Low Dose Cyclosporine and Steroids.
This study will compare the following immunosuppressive regimens in recipients of kidney transplantation: A) everolimus, cyclosporine and steroids given once-a-day; B) everolimus and cyclosporine given twice a day with steroid…
- Trial name
- EVIDENCE (NCT01023815)
- Testing
- everolimus, cyclosporine, Prednison (continuous steroids)
- Where
- 28 sites in Italy
- Volunteers
- 330 people
- Sponsor
- Novartis
Kidney Transplantation
24 Month Extension to Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients(Converted to Mycophenolic Acid After 3 Months) in Renal Transplant Patients
This study will provide continued treatment and assess the long term safety, efficacy and tolerability of oral AEB071 plus tacrolimus vs. mycophenolic acid plus tacrolimus after kidney transplantation.
- Trial name
- NCT00555789
- Testing
- AEB071, mycophenolic plus tacrolimus
- Where
- 27 sites in United States, Canada and 6 more
- Volunteers
- 137 people
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplantation
Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients
The study will evaluate kidney graft function in maintenance renal transplant patients.
- Trial name
- NCT00434590
- Testing
- Enteric coated mycophenolate sodium (Myfortic®)
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
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.
Cytomegalovirus Disease, Kidney Transplant Infection
A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus
This was a randomized, double-blind, double-dummy, parallel-group, multicenter study of the efficacy, safety, and tolerability of oral brincidofovir (BCV) versus valganciclovir for the prevention of cytomegalovirus (CMV) disease…
- Trial name
- NCT02439957
- Testing
- Brincidofovir, Valganciclovir
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Jazz Pharmaceuticals
Kidney Transplant Recipients
Observational Study to Evaluate the Safety and Efficacy of ATG-F on Kidney Transplant Recipients
A multicenter, prospective, observational study to evaluate the safety and efficacy of individual batches of ATG-F in kidney transplant recipients.
- Trial name
- NCT02392312
- Testing
- ATF-Fresenius S
- Where
- 25 sites in China
- Volunteers
- 950 people
- Sponsor
- Astellas Pharma China, Inc.
Kidney Failure, Graft Rejection
Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients
The purpose of this study is to test two different sirolimus-based immunosuppressive regimens for elderly kidney transplant recipients.
- Conditions
- Kidney Failure, Graft Rejection, Aged
- Trial name
- NCT00254709
- Testing
- Sirolimus
- Volunteers
- 66 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Kidney Transplant Immunosuppression
Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients
This prospective, randomized controlled study is intended to enroll 152 patients in the early stages of donor kidney transplantation at six clinical centers in China between January 2023 and January 2024.
- Trial name
- NCT06114953
- Testing
- Mizoribine, Mycophenolate Mofetil
- Where
- 6 sites in China
- Volunteers
- 152 people
- Sponsor
- Lee's Pharmaceutical Limited
Kidney Transplantation
A One-year, Open Label Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients.
The study is a one-year prospective, open-label, safety and efficacy study. De novo renal transplant recipients will be receiving cyclosporine, 1.44g EC-MPS (720 mg b.i.d.), and corticosteroids .The study will consist of a…
- Trial name
- NCT00154245
- Testing
- Enteric-Coated Mycophenolate sodium (EC-MPS)
- Volunteers
- 20 people
- Sponsor
- Novartis