A Study to Compare the Conversion to Prograf® (Tacrolimus) to the Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure (CRAF)

Astellas

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation; Graft Rejection

Treatments: Drug: tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00510913

20-98-002

Details and patient eligibility

About

A study to compare the conversion to Prograf® (tacrolimus) to the continuation of cyclosporine in patients at risk for chronic renal allograft failure

Full 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

Enrollment: 450 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)