A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients
NCT00384137 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128
Last updated 2014-07-09
Summary
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 regimen.
Conditions
- Transplantation
Interventions
- DRUG
-
Immunosuppression
Sponsors & Collaborators
-
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Use Central Contact · Astellas Pharma GmbH
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-10-31
- Primary Completion
- 2007-07-31
- Completion
- 2007-07-31
Countries
- France
- Germany
- Netherlands
- Poland
- Spain
- United Kingdom
Study Locations
More Related Trials
-
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
NCT02963103 ·Status: TERMINATED ·Phase: PHASE4
-
Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
NCT00717379 ·Status: COMPLETED ·Phase: PHASE4
-
Comparing Efficacy & Safety of Tacrolimus & MMF With/Without Induction in the Elderly Following Kidney Transplantation.
NCT00296309 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection
NCT00133172 ·Status: TERMINATED ·Phase: PHASE4
-
Efficacy and Safety of a Reduced Immunosuppression vs. Standard Triple Therapy in Senior Renal Transplant Recipients
NCT02453867 ·Status: UNKNOWN ·Phase: PHASE4
-
A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection
NCT00717470 ·Status: COMPLETED ·Phase: PHASE4
-
Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients
NCT00064701 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Kidney Transplantation
NCT00189839 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation
NCT00204191 ·Status: UNKNOWN ·Phase: PHASE4
-
Efficacy and Safety Study of the Switch From Cyclosporin to Tacrolimus in Renal Transplant Recipients
NCT02706678 ·Status: COMPLETED ·Phase: PHASE4
-
A Study Looking at Kidney Function in Kidney Transplant Recipients Who Are Taking Anti-rejection Medication Including Tacrolimus and With or Without Sirolimus.
NCT01363752 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Evaluate FK778 in Kidney Transplant Patients
NCT00189735 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess the Safety and Efficacy of Prograf and MR4 in Kidney Transplantation Patients
NCT00720265 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule
NCT02268201 ·Status: TERMINATED ·Phase: PHASE4
-
A Study to Compare the Conversion to Prograf® (Tacrolimus) to the Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
NCT00510913 ·Status: COMPLETED ·Phase: PHASE4
-
To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.
NCT00296361 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Liver Transplant Patients
NCT00282243 ·Status: COMPLETED ·Phase: PHASE2
-
Global, Multicentre, Non Interventional Advagraf Conversion Registry in Kidney Transplant Patients
NCT02555787 ·Status: COMPLETED
-
Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium, After Equimolar Conversion From Mycophenolate Mofetil (MMF), in Patients With Stable Renal Transplant Receiving Tacrolimus
NCT00171392 ·Status: COMPLETED ·Phase: PHASE3
-
Standard Versus Prolonged-release Tacrolimus Monotherapy After Alemtuzumab Induction in Kidney Transplantation
NCT00807144 ·Status: COMPLETED ·Phase: PHASE4
-
Mycophenolate Mofetil (MMF) Discontinuation From a Tacrolimus/MMF/Steroid Triple Regimen After Kidney Transplantation
NCT00693381 ·Status: COMPLETED ·Phase: PHASE3
-
Tacrolimus as Secondary Intervention vs. Continuation of Cyclosporine in Renal Transplant Patients With Chronic Renal Allograft Failure (CRAF)
NCT00637143 ·Status: COMPLETED ·Phase: PHASE4
-
Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx
NCT01187953 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Renal Transplant Patients Converted From the Twice Per Day Form of Tacrolimus (Prograf®) to the Once Per Day Form (Advagraf®)
NCT02147938 ·Status: COMPLETED
-
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
NCT00555789 ·Status: TERMINATED ·Phase: PHASE2