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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00637143
First Posted: March 17, 2008
Last Update Posted: February 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Astellas Pharma Canada, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]

Secondary Outcome Measures:
  • Patient Survival [ Time Frame: 5 years ]

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
Oral
Drug: Tacrolimus
Oral
Other Names:
  • FK506
  • Prograf
Active Comparator: 2
Oral
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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, M5C 2T2
Toronto, Ontario, Canada, M5G 2N2
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

Additional Information:
Publications:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00637143     History of Changes
Other Study ID Numbers: FKC-003
First Submitted: March 10, 2008
First Posted: March 17, 2008
Last Update Posted: February 16, 2017
Last Verified: February 2017

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

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