To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.
NCT00296361 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 634
Last updated 2014-09-01
Summary
Primary objective of this study is to compare the two therapy regimens with regard to renal function by using calculated creatinine clearance. The secondary objectives are to compare the efficacy and safety profiles of the two therapy regimens.
Conditions
- Kidney Transplantation
Interventions
- DRUG
-
immunosuppression
Sponsors & Collaborators
-
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Medical Physician · Astellas Pharma Europe B.V.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-10-31
- Primary Completion
- 2006-07-31
- Completion
- 2006-07-31
Countries
- Australia
- Austria
- Belgium
- Czechia
- France
- Germany
- Hungary
- Italy
- Netherlands
- Poland
- Romania
- Spain
- Sweden
- United Kingdom
Study Locations
More Related Trials
-
Study Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients
NCT00895583 ·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 Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients
NCT00282568 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
NCT00717379 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of Two Tacrolimus Based Immunosuppressive Regimens in Recipients Receiving Marginal Donor Kidneys
NCT00321113 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Ascertain if Prolonged Release Tacrolimus (FK506E - MR4) is Safe and Effective When Used in the Long Term and in Combination With Other Immunosuppressive Drugs in Patients Who Have Received a Transplant
NCT02118896 ·Status: COMPLETED ·Phase: PHASE3
-
Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients
NCT02683291 ·Status: COMPLETED ·Phase: PHASE4
-
Study Comparing Standard Dose and Reduced Dose Tacrolimus + Sirolimus + Corticosteroids in Renal Allograft Recipients
NCT00518271 ·Status: COMPLETED ·Phase: PHASE2
-
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
-
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Kidney Recipients
NCT00384137 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients
NCT00617604 ·Status: COMPLETED ·Phase: PHASE2
-
Study Comparing in Livertransplantation Recipients With Tacrolimus Alone Versus Tacrolimus&Sirolimus
NCT01958190 ·Status: COMPLETED ·Phase: PHASE4
-
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
-
Comparative Study of Modified Release (MR) Tacrolimus/Mycophenolate Mofetil (MMF) in de Novo Kidney Transplant Recipients
NCT00064701 ·Status: COMPLETED ·Phase: PHASE3
-
Comparing Efficacy & Safety of Tacrolimus With/Without MMF or Monoclonal Anti-IL2R Antibody in Liver Transplantation.
NCT00295594 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of 3g Versus 2 g MMF in Combination With Tacrolimus on Progression of Renal Allograft Interstitial Fibrosis
NCT01860183 ·Status: COMPLETED ·Phase: PHASE4
-
The Effect of Sirolimus on the Pharmacokinetics of Tacrolimus
NCT00166829 ·Status: UNKNOWN ·Phase: PHASE4
-
Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation
NCT00297310 ·Status: COMPLETED ·Phase: PHASE4
-
The Comparison of Three Different Immunosuppressant Regimens in Kidney Transplant Recipients.
NCT00275522 ·Status: COMPLETED ·Phase: PHASE4
-
Study Comparing Standard Dose and Reduced Dose Tacrolimus With Sirolimus in Renal Transplant Patients
NCT00519116 ·Status: COMPLETED ·Phase: PHASE4
-
Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients
NCT00311311 ·Status: TERMINATED ·Phase: PHASE3
-
Efficacy and Safety of a Reduced Immunosuppression vs. Standard Triple Therapy in Senior Renal Transplant Recipients
NCT02453867 ·Status: UNKNOWN ·Phase: PHASE4
-
Study Evaluating Two Different Sirolimus-based Immunosuppressive Regimens in Elderly Kidney Transplant Recipients
NCT00254709 ·Status: COMPLETED ·Phase: PHASE4
-
Comparison of the Two Immunosuppressive Regimens Based on Tacrolimus and Cyclosporine Following Kidney Transplantation
NCT00204191 ·Status: UNKNOWN ·Phase: PHASE4
-
Extension Study Of Stage 1 Subjects Of Study A3921009 For The Prevention Of Acute Rejection In Kidney Transplant Patient
NCT00263328 ·Status: COMPLETED ·Phase: PHASE2