A Study to Compare Early Steroid Withdrawal and Long-Term Steroid Maintenance Therapy in Kidney Transplant Patients

November 15, 2011 updated by: Astellas Pharma Inc

A Prospective, Randomized, Multi-Center Double-Blind Study of Early Corticosteroid Cessation vs. Long Term Corticosteroid Therapy With Prograf and CellCept in Primary Renal Transplant Patients

A study comparing the early withdrawal of steroids to long-term maintenance steroid therapy in Kidney Transplant Patients receiving Prograf and Cellcept

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

397

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

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Loma Linda, California, United States, 92354
      • Los Angeles, California, United States, 90057
    • Colorado
      • Denver, Colorado, United States, 80262
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Kentucky
      • Lexington, Kentucky, United States, 40536
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
    • Michigan
      • Detroit, Michigan, United States, 48202
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
      • Rochester, Minnesota, United States, 55905
    • Nebraska
      • Omaha, Nebraska, United States, 68198
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
    • New York
      • Buffalo, New York, United States, 14203
      • New York, New York, United States, 10021
      • New York, New York, United States, 10029
    • Ohio
      • Cincinnati, Ohio, United States, 45267
      • Cleveland, Ohio, United States, 44106
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
    • Tennessee
      • Memphis, Tennessee, United States, 38163
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Galveston, Texas, United States, 77555
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84132
      • Salt Lake City, Utah, United States, 84103
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
      • Milwaukee, Wisconsin, United States, 53226

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

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion:

  • Patient is between post kidney transplant day 3-7 and no requirement for dialysis

Exclusion:

  • Patient is receiving kidney from HLA identical,living donor
  • Patient is a multi-organ transplant recipient
  • Patient is pregnant or lactating. Female patients of child bering potential must have a negative pregnancy test and agree to practice effective birth control

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
early steroid cessation
Drug: tacrolimus
Oral
Other Names:
  • Prograf
  • FK506
Drug: CellCept
IV or Oral
Other Names:
  • MMF
  • Mycophenolate mofetil
Drug: steroids (methylprednisone or prednisone)
IV or Oral
Other Names:
  • prednisone
  • methylprednisone
Experimental: 2
long-term maintenance steroids
Drug: tacrolimus
Oral
Other Names:
  • Prograf
  • FK506
Drug: CellCept
IV or Oral
Other Names:
  • MMF
  • Mycophenolate mofetil
Drug: steroids (methylprednisone or prednisone)
IV or Oral
Other Names:
  • prednisone
  • methylprednisone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of death, graft loss, or severe acute rejection
Time Frame: 6 months, 12 months, yearly up to 5 years
6 months, 12 months, yearly up to 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Comparison of patient and graf survival
Time Frame: 6 months, 12 months, yearly up to 5 years
6 months, 12 months, yearly up to 5 years
Incidence and severity of acute rejection
Time Frame: 6 months, 12 months, yearly up to 5 years
6 months, 12 months, yearly up to 5 years
Need for antilymphocyte treatment
Time Frame: 6 months, 12 months, yearly up to 5 years
6 months, 12 months, yearly up to 5 years
Graft function
Time Frame: 6 month, 12 months, yearly up to 5 years
6 month, 12 months, yearly up to 5 years
Framingham Coronary Heart Disease Risk Factors
Time Frame: 6 months, 12 months, yearly up to 5 years
6 months, 12 months, yearly up to 5 years

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

Investigators

  • Study Director: Central Contact, Astellas Pharma US, 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

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

November 1, 1999

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 17, 2008

First Submitted That Met QC Criteria

March 28, 2008

First Posted (Estimate)

April 1, 2008

Study Record Updates

Last Update Posted (Estimate)

November 17, 2011

Last Update Submitted That Met QC Criteria

November 15, 2011

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-99-001

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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