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 · Type: INTERVENTIONAL · Enrollment: 853
Last updated 2024-10-31
Summary
The purpose of this study is to compare the effect of two anti-rejection therapy regimens on kidney function in kidney transplant recipients.
Conditions
- Kidney Transplantation
Interventions
- DRUG
-
Advagraf
oral
- DRUG
-
Mycophenolate Mofetil
oral
- DRUG
-
Sirolimus
oral
- DRUG
-
i.v. and oral
Sponsors & Collaborators
-
Astellas Pharma Inc
lead INDUSTRY
Principal Investigators
-
Use Central Contact · Astellas Pharma Europe Ltd.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2011-03-08
- Primary Completion
- 2013-09-18
- Completion
- 2013-09-18
Countries
- Australia
- Austria
- Belarus
- Belgium
- Czechia
- France
- Germany
- Hong Kong
- Hungary
- Italy
- Netherlands
- Poland
- Russia
- South Korea
- Spain
- Taiwan
- Turkey (Türkiye)
Study Locations
More Related Trials
-
Study to Evaluate the Safety and Efficacy of Advagraf vs Prograf in Kidney Transplantation Patients 1 Month After the Transplantation
NCT01742624 ·Status: COMPLETED ·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
-
The Comparison of Tacrolimus and Sirolimus Immunosuppression Based Drug Regimens in Kidney Transplant Recipients
NCT00275535 ·Status: COMPLETED ·Phase: PHASE4
-
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
-
To Compare the Efficacy and Safety of a Therapy of Tacrolimus With Sirolimus or MMF in Kidney Transplantation.
NCT00296361 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Compare the Pharmacokinetics of Tacrolimus in Stable Pediatric Allograft Recipients Converted From Prograf® to Advagraf®
NCT01294020 ·Status: COMPLETED ·Phase: PHASE2
-
Study of Tacrolimus Immunosuppressive Therapy After Kidney Transplantation
NCT00717379 ·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
-
A Study to Assess the Safety and Efficacy of ADVAGRAF (Tacrolimus Modified Release Formulation) in Kidney Transplant Patients Who Were Treated With PROGRAF
NCT01839929 ·Status: COMPLETED ·Phase: PHASE4
-
A Pilot Study Comparing the Use of Low-target Versus Conventional Target Advagraf
NCT01265537 ·Status: COMPLETED ·Phase: NA
-
Study to Evaluate the Safety and Efficacy of Extended Release Tacrolimus (Advagraf®) + Sirolimus (Rapamune®), Versus Extended Release Tacrolimus (Advagraf®) + Mycophenolate Mofetil in Kidney Transplant Patients
NCT01680952 ·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 Evaluating A Planned Transition From Tacrolimus To Sirolimus In Kidney Transplant Recipients
NCT00895583 ·Status: COMPLETED ·Phase: PHASE4
-
Tacrolimus Minimization in Kidney Transplant Recipients Selected According to the AGORA Algorithm for Their Low Immunological Risk and Medium-term Graft Failure
NCT06235892 ·Status: RECRUITING ·Phase: PHASE3
-
Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
NCT00903188 ·Status: UNKNOWN ·Phase: PHASE4
-
Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts
NCT00933231 ·Status: COMPLETED ·Phase: PHASE3
-
The Comparison of Three Different Immunosuppressant Regimens in Kidney Transplant Recipients.
NCT00275522 ·Status: COMPLETED ·Phase: PHASE4
-
A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
NCT02057484 ·Status: COMPLETED
-
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 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
NCT02034747 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluaion the Short Term Effects of Advograf Plus Rapamiune After Kidney Transplantation
NCT07033858 ·Status: RECRUITING ·Phase: NA
-
A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection
NCT00717470 ·Status: COMPLETED ·Phase: PHASE4
-
Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function
NCT02334488 ·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
-
Tacrolimus/Sirolimus Versus Tacrolimus/Mycophenolate Mofetil (MMF) Versus Neoral/Sirolimus in Adult, Primary Kidney Transplantation
NCT00681213 ·Status: COMPLETED ·Phase: PHASE4