A Study to Evaluate the Safety and Efficacy of Prograf/FK778 and Prograf/MMF in de Novo Kidney Transplant Recipients

June 6, 2012 updated by: Astellas Pharma Inc

A Phase 2, Randomized, Open-Label, Parallel Group, Multi-Center Study to Assess the Safety and Efficacy of Prograf®/FK778 and Prograf®/MMF in De Novo Kidney Transplant Recipients

A study to evaluate the safety and efficacy of Prograf/FK778 in de novo kidney transplant patients

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

150

Phase

  • Phase 2

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
    • Alabama
      • Birmingham, Alabama, United States, 35294
    • California
      • Los Angeles, California, United States, 90057
      • San Diego, California, United States, 92123
    • Colorado
      • Denver, Colorado, United States, 80262
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Jacksonville, Florida, United States, 32216
      • Miami, Florida, United States, 33136
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Kansas
      • Wichita, Kansas, United States, 67214
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Michigan
      • Detroit, Michigan, United States, 80262
    • New Jersey
      • New Brunswick, New Jersey, United States, 89003
    • New York
      • New York, New York, United States, 10021
      • New York, New York, United States, 10029
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Cincinnati, Ohio, United States, 45267
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17104
      • Philadelphia, Pennsylvania, United States, 19107
    • Tennessee
      • Memphis, Tennessee, United States, 38163
    • Utah
      • Salt Lake City, Utah, United States, 84132
    • 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient is a recipient of a primary or retransplanted cadaveric or non-HLA-identical living donor kidney.
  • Patient must receive first oral dose of randomized study drug within 48 hours of transplant procedure.

Exclusion Criteria:

  • Patient has received or is receiving an organ transplant other than kidney
  • Patient has received a kidney transplant from a cadaveric donor >= 60 years of age.

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of biopsy confirmed acute rejection (Banff Grade ≥ I) at 6 months.

Secondary Outcome Measures

Outcome Measure
6 month patient and graft survival rates
time to first biopsy confirmed acute rejection
clinically treated acute rejection episodes
treatment failure (up to 6 months)
renal function (SrCl and CrCl)
quantitation of CMV and polyomavirus viral load

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma US, Inc.

Investigators

  • Study Director: John Holman, MD, Astellas Pharma US, Inc.

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, 2003

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

January 24, 2006

First Submitted That Met QC Criteria

January 24, 2006

First Posted (Estimate)

January 26, 2006

Study Record Updates

Last Update Posted (Estimate)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 6, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 03-0-165

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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