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

Phase 4

Completed

• Conditions: Renal Transplantation; Chronic Renal Allograft Failure
• Interventions: Drug: Tacrolimus; Drug: Cyclosporine

• Registration Number: NCT00637143
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 1999-04
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2008-03-10
• Study First Submitted QC: 2008-03-14
• Study First Posted: 2008-03-17
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Tacrolimus	Oral
2	Cyclosporine	Oral

Primary Outcome Measures

Name	Time	Method
Graft Survival	5 years

Secondary Outcome Measures

Name	Time	Method
Patient Survival	5 years