Official Title: “Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2006

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.

Intervention(s) in this Clinical Trial

• Drug: Tacrolimus
  • Oral
• Drug: Cyclosporine
  • Oral

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Graft Survival
  • Time Frame: 5 years
    Safety Issue?: No

Secondary Measures

• Patient Survival
  • Time Frame: 5 years
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Astellas Pharma Inc

Overall Clinical Trial Officials and Contacts

Central Contact Study Chair Astellas Pharma Canada, Inc.  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00637143

Study ID Number: FKC-003

ClinicalTrials.gov Identifier: NCT00637143

Health Authority: Canada: Health Canada