Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection

September 5, 2014 updated by: Astellas Pharma Inc

Evaluation of the Long-term Safety and Efficacy of a Tacrolimus-based 5-day Steroid Rapid Withdrawal Immunoprophylactic Regimen in de Novo Renal Transplantation

The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.

Study Overview

Study Type

Interventional

Enrollment (Actual)

85

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

    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
      • Edmonton, Alberta, Canada, T6G 2B7
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
      • Vancouver, British Columbia, Canada, V5Z 1C6
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
      • London, Ontario, Canada, N6A 5A5
      • Ottawa, Ontario, Canada, K1H 7W9
      • Toronto, Ontario, Canada, M5G 2N2
      • Toronto, Ontario, Canada, M5C2T2
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
      • Montreal, Quebec, Canada, H3A 1A1
      • Montreal, Quebec, Canada, H2L 4M1
      • Quebec City, Quebec, Canada, G1R 2J6
    • 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures.
  • Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant.
  • Subject is 18 years of age or over at the time of 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 60 years of age or older
  • Recipients of donation after cardiac death (DCD) donors
  • Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart)
  • Subjects with a second renal allograft who had their original graft for < 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure
  • Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) >20
  • Subjects with hepatitis B & C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma)
  • Subjects receiving an allograft with cold ischemia time 24 hours or greater
  • Subjects who have received an investigational drug within three months prior to randomization
  • Subjects who are breastfeeding
  • Subjects with known hypersensitivity to tacrolimus, mycophenolate mofetil, methylprednisolone, basiliximab, prednisone, or any related drugs or their excipients
  • Subjects with significant disease (e.g. uncontrolled infection) or disability (e.g. cognitive deficit) that prevents understanding of or 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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Steroid rapid 5-day withdrawal
IV
Other Names:
  • Prograf
  • FK506
IV
Other Names:
  • Cellcept
IV
ACTIVE_COMPARATOR: 2
Standard steroid maintenance
IV
Other Names:
  • Prograf
  • FK506
IV
Other Names:
  • Cellcept
IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR)
Time Frame: 3 months post transplant
3 months post transplant

Secondary Outcome Measures

Outcome Measure
Time Frame
Biopsy proven chronic allograft nephropathy(CAN)
Time Frame: 2 years post transplant
2 years post transplant
Patient and graft survival rates
Time Frame: End of study (5 years)
End of study (5 years)

Collaborators and Investigators

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

Investigators

  • Study Director: Medical Monitor, 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.

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

July 1, 2005

Primary Completion (ACTUAL)

March 1, 2007

Study Completion (ACTUAL)

March 1, 2007

Study Registration Dates

First Submitted

August 22, 2005

First Submitted That Met QC Criteria

August 22, 2005

First Posted (ESTIMATE)

August 23, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

September 8, 2014

Last Update Submitted That Met QC Criteria

September 5, 2014

Last Verified

September 1, 2014

More Information

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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