Tacrolimus as Secondary Intervention vs. Continuation of Cyclosporine in Renal Transplant Patients With Chronic Renal Allograft Failure (CRAF)

Astellas

Status and phase

Completed

Phase 4

Conditions

Renal Transplantation

Chronic Renal Allograft Failure

Treatments

Drug: Tacrolimus

Drug: Cyclosporine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00637143

FKC-003

Details and patient eligibility

About

The purpose of this study is to compare renal transplant recipients on cyclosporine maintenance therapy vs. those converted to tacrolimus-based immunosuppression with respect to renal outcomes.

Full description

The objective of this study is to compare the incidence, progression and severity of chronic renal allograft failure in at-risk patients who are converted from cyclosporine to tacrolimus-based immunosuppression to patients who remain on cyclosporine.

Enrollment

107 patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient is at least 3 months post-transplant of a cadaveric or living donor kidney
Patient has been on a cyclosporine-based immunosuppression regimen since the transplant
Patient has one of the following risk factors for chronic renal allograft failure at the baseline biopsy:
- Serum creatinine: Male: >=2.0mg/dL (176.8 umol/L); Female: >= 1.7mg/dL (150.28 umol/L) 3 months or later post-transplant
- Serum creatinine > 30% increased over post-discharge nadir
Patient has had a renal biopsy > 3 months after transplant and within 6 months prior to enrollment
Patient or legal guardian has signed and dated an IRB approved informed consent document
Female patient has a negative pregnancy test and agrees to practice effective birth control while receiving mycophenolate mofetil (MMF)

Exclusion criteria

Patient is dialysis dependent and has recurrence of primary or de novo renal disease
Patient has an estimated creatinine clearance <25mL/min
Patient has changed maintenance immunosuppressant therapy (e.g., azathioprine to MMF) within 3 months of randomization
Baseline biopsy shows acute rejection Grade >=IIB using Banff 95 criteria or >= Grade IIA using Banff 97 criteria
Patient requires antilymphocyte therapy to treat rejection at baseline or post-baseline biopsy
Patient has received an investigational immunosuppressant within 3 months, or has a known hypersensitivity to tacrolimus, or any excipients of the drug
Patient is a known carrier of any of the HIV viruses