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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00637143
First received: March 10, 2008
Last updated: September 17, 2014
Last verified: September 2014

March 10, 2008
September 17, 2014
April 1999
February 2006   (final data collection date for primary outcome measure)
Graft Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00637143 on ClinicalTrials.gov Archive Site
Patient Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Tacrolimus as Secondary Intervention vs. Continuation of Cyclosporine in Renal Transplant Patients With Chronic Renal Allograft Failure (CRAF)
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Renal Transplantation
  • Chronic Renal Allograft Failure
  • Drug: Tacrolimus
    Oral
    Other Names:
    • Prograf
    • FK506
  • Drug: Cyclosporine
    Oral
    Other Name: Neoral
  • Experimental: 1
    Intervention: Drug: Tacrolimus
  • Active Comparator: 2
    Intervention: Drug: Cyclosporine
Jevnikar A, Arlen D, Barrett B, Boucher A, Cardella C, Cockfield SM, Rush D, Paraskevas S, Shapiro J, Shoker A, Yilmaz S, Zaltzman JS, Kiberd B. Five-year study of tacrolimus as secondary intervention versus continuation of cyclosporine in renal transplant patients at risk for chronic renal allograft failure. Transplantation. 2008 Oct 15;86(7):953-60. doi: 10.1097/TP.0b013e318186dd0c.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
107
February 2006
February 2006   (final data collection date for primary outcome measure)

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
Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00637143
FKC-003
No
Astellas Pharma Inc
Astellas Pharma Inc
Astellas Pharma Canada, Inc.
Study Chair: Central Contact Astellas Pharma Canada, Inc.
Astellas Pharma Inc
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP