Clinical trials: Stable Renal Recipients
Transplantation
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients
Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable kidney transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive…
- Trial name
- NCT00384137
- Testing
- Tacrolimus
- Where
- 13 sites in France, Germany and 4 more
- Volunteers
- 128 people
- Sponsor
- Astellas Pharma Inc
Kidney Diseases
Enteric-coated Mycophenolate Sodium (EC-MPS) With Reduced-dose Tacrolimus Versus EC-MPS With Standard-dose Tacrolimus in Stable Kidney Transplant Recipients
This study introduces a new optimization immunosuppressive regimen associating tacrolimus at a reduced dose and enteric-coated mycophenolate sodium at an increased dose in order to slow down renal function worsening and to…
- Trial name
- OLYMPE (NCT00284934)
- Testing
- Enteric-coated mycophenolate sodium (EC-MPS), Tacrolimus, Corticosteroids
- Where
- Switzerland
- Volunteers
- 94 people
- Sponsor
- Novartis
Kidney Transplant
MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients
The purpose of this study is to Evaluate the Efficacy and Safety of MYREPTIC-N® or MY-REPT® in Stable Patients after Kidney Transplant Recipients
- Trial name
- MyMy (NCT06044493)
- Testing
- Myreptic-N Tablet, Mycophenolate mofetil Tablet/Capsule
- Where
- South Korea
- Volunteers
- 158 people
- Sponsor
- Chong Kun Dang Pharmaceutical
Renal Transplantation, Kidney Transplantation
A Single Center, Open-label, Randomized, Pilot Study to Evaluate the Safety and Efficacy of a Tacrolimus Modified Release, ADVAGRAF®, Versus Tacrolimus Twice Daily, PROGRAF® in Stable Renal Recipients
The purpose of this study is to evaluate and compare the safety and efficacy of two drugs (ADVAGRAF® and PROGRAF® groups) in patients who received renal transplantation.
- Conditions
- Renal Transplantation, Kidney Transplantation, Stable Renal Recipients
- Trial name
- SINGLE (NCT01742676)
- Testing
- ADVAGRAF, PROGRAF
- Where
- South Korea
- Volunteers
- 100 people
- Sponsor
- Astellas Pharma Korea, Inc.
Kidney Transplantation
An Open Study Assessing Bioavailability of a Modified Formulation of Tacrolimus in Kidney Transplant Recipients
The purpose of this study is to evaluate the effect of food on the oral bioavailability of tacrolimus modified release (MR4) capsules together with a standard continental breakfast.
- Trial name
- NCT00865137
- Testing
- Tacrolimus, modified release
- Where
- Netherlands
- Volunteers
- 27 people
- Sponsor
- Astellas Pharma Inc
Renal Transplantation
A Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)
The aim of this study is whether a switch of stable renal transplant recipients who receive tacrolimus with or without corticosteroids from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium (EC-MPS) is safe and…
- Trial name
- NCT00238979
- Testing
- Enteric-Coated Mycophenolate Sodium (EC-MPS)
- Volunteers
- 50 people
- Sponsor
- Novartis Pharmaceuticals
Transplant Rejection, Renal Transplantation
Study To Evaluate Pharmacokinetics Of Sirolimus In Stable Renal Transplant Recipients
Sirolimus, 1 mg, white, triangular tablets (Rapamune®) was approved on 03 April 2007 in China for prophylaxis of organ rejection in renal transplantation.
- Trial name
- NCT01236378
- Testing
- Sirolimus
- Where
- 2 sites in China
- Volunteers
- 24 people
- Sponsor
- Pfizer
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.
Renal Transplantation
Comparison of CNI-based Regimen Versus CNI-free Regimen in Kidney Transplant Recipients.
Calcineurin inhibitors (CNI), a potent immunosuppressive drug used in kidney transplant recipients to prevent graft rejection, may cause renal impairment.
- Trial name
- NCT00332839
- Testing
- Everolimus, Cyclosporin A (CsA), Tacrolimus
- Where
- 11 sites in Germany
- Volunteers
- 93 people
- Sponsor
- Novartis Pharmaceuticals
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.
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 Transplant
A Study to Assess the Efficacy and Safety of Advagraf® Switching From Cyclosporine Between the Group That Was Treated With a 50% Reduced Corticosteroid and the Group With Maintained Corticosteroid for Stable Kidney Transplant Recipients
This study is a multicenter, randomized, comparison, open-label, phase IV study in kidney transplant recipients whose immunosuppressive regimen is converted from Cyclosporine with corticosteroid to Advagraf® with corticosteroid.
- Trial name
- COSMOS (NCT02034747)
- Testing
- Advagraf, Corticosteroid
- Where
- 9 sites in South Korea
- Volunteers
- 150 people
- Sponsor
- Astellas Pharma Korea, Inc.
Kidney Transplant
A Study Of CP-690,550 In Stable Kidney Transplant Patients
This was a Phase 1 dose escalation study to evaluate the safety, tolerability and pharmacokinetics of 28-day treatment of CP-690,550 in stable renal allograft recipients.
- Trial name
- NCT01710033
- Testing
- CP-690,550 5 mg BID, CP-690,550 15 mg BID, CP-690,550 30 mg BID
- Where
- 11 sites in United States
- Volunteers
- 28 people
- Sponsor
- Pfizer
Kidney Transplantation
Immediate Conversion From Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients
The purpose of this study is to investigate safety and tolerability of an immediate conversion from Tacrolimus to everolimus in stable renal allograft recipients.
- Trial name
- HERMES (NCT01269684)
- Testing
- Everolimus
- Where
- Switzerland
- Sponsor
- Novartis Pharmaceuticals
Kidney Transplant
Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients
The purpose of this study is to evaluate how well adolescent kidney transplant patients tolerate a single dose of belatacept they receive at least 6 months after transplant surgery, and how their body handles the drug.
- Trial name
- NCT01791491
- Testing
- Belatacept
- Where
- 8 sites in United States
- Volunteers
- 16 people
- Sponsor
- Bristol-Myers Squibb