A Study to Compare the Conversion to Prograf® (Tacrolimus) to the Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure
Phase 4
Completed
- Conditions
- Graft RejectionKidney Transplantation
- Registration Number
- NCT00510913
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
A study to compare the conversion to Prograf® (tacrolimus) to the continuation of cyclosporine in patients at risk for chronic renal allograft failure
- Detailed Description
A two arm study (1 Active, 1 Active control) to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine-based to tacrolimus-based immunosuppression to patients who remain on cyclosporine-based therapy
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
- Patient has been on cyclosporine-based immunosuppression regimen since the transplant
- Patient has at least one pre-defined risk factor for chronic allograft failure
Exclusion Criteria
- Patient is dialysis dependent
- Patient is recipient of a solid organ transplant other than the kidney
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Graft Survival 5 years
- Secondary Outcome Measures
Name Time Method Patient survival, Graft Loss 5 years