A Study to Evaluate FK778 in Kidney Transplant Patients

April 15, 2008 updated by: Astellas Pharma Inc

A Multicentre, Randomised, Double-Blind, Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Different Concentrations of FK778 With Tacrolimus (FK506) and Steroids Versus a Standard Regimen of Tacrolimus, MMF and Steroids in Renal Transplant Patients

A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

364

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

  • Austria
      • Innsbruck, Austria, 6020
  • Belgium
      • Brussels, Belgium, 1200
      • Brussels, Belgium, 1070
      • Leuven, Belgium, 3000
  • Czech Republic
      • Praha 4, Czech Republic, 14021
  • France
      • Brest, France, 29 200
      • Creteil Cedex, France, 94010
      • Grenoble Cedex 9, France
      • Le Kremlin Bicetre Cedex, France, 94275
      • Montpellier Cedex 05, France, 34295
      • Rennes Cedex, France, 35003
      • Saint-Etienne Cedex 02, France, 42055
      • Toulouse, France, 31 403
  • Germany
      • Berlin, Germany, 10117
      • Berlin, Germany, 13353
      • Essen, Germany, 45122
      • Frankfurt, Germany, 60590
      • Halle/Saale, Germany, 06112
      • Munchen, Germany, 81675
      • Regensburg, Germany, 93053
  • Italy
      • Padova, Italy, 35128
      • Roma, Italy, 00168
      • Torino, Italy, 10126
  • Netherlands
      • Maastricht, Netherlands, 6202
  • Poland
      • Bydgoszcz, Poland, 85-094
      • Szczecin, Poland, 70-111
  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08907
      • Barcelona, Spain, 08025
      • Cordoba, Spain, 14004
      • Madrid, Spain, 28034
      • Madrid, Spain, 28041
      • Santander, Spain, 39008
      • Valencia, Spain, 46009
  • Sweden
      • Uppsala, Sweden, 75185
  • Switzerland
      • Zurich, Switzerland, 8091
  • United Kingdom
      • Manchester, United Kingdom, M13 9WL

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 has end stage kidney disease or needs retransplantation (loss of graft for non-immunological reasons).
  • Patient has been fully informed.

Exclusion Criteria:

  • Patient has an immunological high risk and/or having a previous graft survival shorter than 1 year due to immunological reasons.
  • Patient has significant liver disease.
  • Cold ischemia time of the donor kidney >28 hours.
  • Patient having uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.
  • Patient has previously received or is receiving an organ transplant other than kidney.

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of biopsy-proven acute rejection over the first 24 weeks.

Secondary Outcome Measures

Outcome Measure
Incidence of adverse events
Efficacy:Incidence of and time to first biopsy-proven acute rejection over the first 24 weeks and after 1 year
Incidence of and time to first corticosteroid-resistant acute rejections over the first 24 weeks and after 1 year
Incidence of and time to first acute rejection by signs and symptoms over the first 24 weeks and after 1 year
Severity of biopsy-proven acute rejections (Banff criteria) over the first 24 weeks and after 1 year
Frequency of treatment failure (as defined below) over the first 24 weeks and after 1 year
Renal function as measured by serum creatinine concentrations and calculated creatinine clearance (Cockcroft formula) over the first 24 weeks and after 1 year
Chronic allograft dysfunction assessed by chronic allograft damage index (CADI) after 24 weeks of transplantation.
Safety first 24 weeks: Patient survival
Graft survival
Routine safety laboratory parameters
Haemoglobin values at weeks two to six
Leukocytes at weeks two to six
Thrombocytes at weeks two to six
Bilirubin at weeks two to six
Incidence of CMV viraemia
Incidence of Diarrhoea, Gastroenteritis and Gastritis
Safety after 1 year:Incidence of adverse events
Patient and graft survival

Collaborators and Investigators

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

Sponsor

Astellas Pharma Inc

Collaborators

Astellas Pharma Europe B.V.

Investigators

  • Principal Investigator: H. H. Neumayer, Universitätsklinik Charité

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, 2003

Primary Completion (Actual)

October 1, 2005

Study Completion (Actual)

October 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Estimate)

April 17, 2008

Last Update Submitted That Met QC Criteria

April 15, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FG-778-02-60

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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