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

February 15, 2017 updated by: Astellas Pharma Inc

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

107

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
      • Edmonton, Alberta, Canada, T6G 2B7
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V8
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
      • London, Ontario, Canada, N6A 5A5
      • Toronto, Ontario, Canada, M5C 2T2
      • Toronto, Ontario, Canada, M5G 2N2
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H3A 1A1
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7M 0Z9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Oral
Drug: Tacrolimus
Oral
Other Names:
  • Prograf
  • FK506
Active Comparator: 2
Oral
Drug: Cyclosporine
Oral
Other Names:
  • Neoral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Graft Survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient Survival
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Canada, Inc.

Investigators

  • Study Chair: Central Contact, Astellas Pharma Canada, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 1999

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

March 10, 2008

First Submitted That Met QC Criteria

March 14, 2008

First Posted (Estimate)

March 17, 2008

Study Record Updates

Last Update Posted (Actual)

February 16, 2017

Last Update Submitted That Met QC Criteria

February 15, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKC-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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