Benefit of Early Protocol Biopsy and Treatment of Subclinical Rejection

September 17, 2014 updated by: Astellas Pharma Inc

The Effects of Treatment of Subclinical Rejection on Renal Histology and Graft Function in Renal Transplant Patients Receiving Tacrolimus and Mycophenolate Mofetil

This multicentre randomized, controlled trial (RCT) compared renal allograft histology and function in subjects treated with Tacrolimus + MMF + prednisone undergoing early protocol biopsies and treatment of subclinical rejection versus a non-protocol biopsy control group.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

240

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, V6Z 1Y6
      • Vancouver, British Columbia, Canada, V5Z 1M9
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
      • Ottawa, Ontario, Canada, K1H 7W9
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H2L 4M1
      • Quebec City, Quebec, Canada, G1R 2J6
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7M 0Z9
  • United States
    • California
      • Palo Alto, California, United States, 94304-1510

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant
  • If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods

Exclusion Criteria:

  • Recipients of a kidney from a donor over 65 years of age
  • Recipient of non-related donor kidney with peak pre-transplant PRA > 50
  • Subject has lost a previous graft to rejection less than one year from transplant
  • Subject who has received an investigational drug within three months prior to randomization
  • Subjects who are pregnant or breastfeeding
  • Subject receives a kidney lacking a pre-implantation biopsy
  • Subject has significant disease or disability (e.g. malignancy or uncontrolled infection) which prevents adherence to the protocol

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
Protocol biopsies at 1, 2 and 3 months
Drug: Tacrolimus
Oral
Other Names:
  • Prograf
  • FK506
Drug: MMF
Oral
Other Names:
  • Cellcept
Drug: Corticosteroids (Prednisone)
Oral
Other Names:
  • Methylprednisolone
  • Prednisone
Active Comparator: 2
No protocol biopsies
Drug: Tacrolimus
Oral
Other Names:
  • Prograf
  • FK506
Drug: MMF
Oral
Other Names:
  • Cellcept
Drug: Corticosteroids (Prednisone)
Oral
Other Names:
  • Methylprednisolone
  • Prednisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of interstitial fibrosis/tubular atrophy as defined by Banff interstitial and tubular chronic changes of ci + ct of 2 or more at 6 months
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The incidence of subclinical rejection at 6 months
Time Frame: 6 months
6 months
Prevalence of chronic renal histopathology at 24 months
Time Frame: 24 months
24 months
Renal function as determined by serum creatinine and 24 hour urine creatinine clearance and protein excretion
Time Frame: 6, 12 and 24 moths
6, 12 and 24 moths

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.

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

September 1, 2001

Primary Completion (Actual)

July 1, 2004

Study Completion (Actual)

January 1, 2006

Study Registration Dates

First Submitted

April 20, 2009

First Submitted That Met QC Criteria

April 21, 2009

First Posted (Estimate)

April 22, 2009

Study Record Updates

Last Update Posted (Estimate)

September 18, 2014

Last Update Submitted That Met QC Criteria

September 17, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FKC-008

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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