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:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00637143
First received: March 10, 2008
Last updated: January 1, 2009
Last verified: March 2008
  Purpose

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.


Condition Intervention Phase
Renal Transplantation
Chronic Renal Allograft Failure
Drug: Tacrolimus
Drug: Cyclosporine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prograf® (Tacrolimus) as Secondary Intervention vs. Continuation of Cyclosporine in Patients at Risk for Chronic Renal Allograft Failure

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Graft Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: April 1999
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Tacrolimus
Oral
Other Names:
  • Prograf
  • FK506
Active Comparator: 2 Drug: Cyclosporine
Oral
Other Name: Neoral

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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637143

Locations
Canada, Alberta
Calgary, Alberta, Canada, T2N 2T9
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Newfoundland and Labrador
St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Nova Scotia
Halifax, Nova Scotia, Canada, B3H 1V8
Canada, Ontario
Hamilton, Ontario, Canada, L8N 4A6
London, Ontario, Canada, N6A 5A5
Toronto, Ontario, Canada, M5G 2N2
Toronto, Ontario, Canada, M5C 2T2
Canada, Quebec
Montreal, Quebec, Canada, H1T 2M4
Montreal, Quebec, Canada, H3A 1A1
Canada, Saskatchewan
Saskatoon, Saskatchewan, Canada, S7M 0Z9
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Canada, Inc.
Investigators
Study Chair: Central Contact Astellas Pharma Canada, Inc.
  More Information

No publications provided

Responsible Party: Sr Manager, Clinical Trial Registry, Astellas Pharma US, Inc.
ClinicalTrials.gov Identifier: NCT00637143     History of Changes
Other Study ID Numbers: FKC-003
Study First Received: March 10, 2008
Last Updated: January 1, 2009
Health Authority: Canada: Health Canada

Keywords provided by Astellas Pharma Inc:
Renal transplant
Tacrolimus
Cyclosporine
Intervention
Chronic Renal Allograft Failure
Interstitial Fibrosis Tubular Atrophy

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
Tacrolimus
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Dermatologic Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on July 22, 2014