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A Study to Evaluate FK778 in Kidney Transplant Patients

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Europe BV
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00189735
First received: September 12, 2005
Last updated: April 15, 2008
Last verified: April 2008
History of Changes
  Purpose

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


Condition Intervention Phase
Kidney Transplantation
Renal Transplantation
Transplantation, Renal
Transplantation, Kidney
Grafting, Kidney
 Drug: FK778
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Incidence of biopsy-proven acute rejection over the first 24 weeks.

Secondary Outcome Measures:
  • 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
  • Incidence of adverse events
  • 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

Enrollment: 364
Study Start Date: September 2003
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00189735

  Hide Study Locations
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, 08907
Barcelona, Spain, 08036
Barcelona, Spain, 08025
Cordoba, Spain, 14004
Madrid, Spain, 28041
Madrid, Spain, 28034
Santander, Spain, 39008
Valencia, Spain, 46009
Sweden
Uppsala, Sweden, 75185
Switzerland
Zurich, Switzerland, 8091
United Kingdom
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Europe BV
Investigators
Principal Investigator: H. H. Neumayer Universitätsklinik Charité
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00189735     History of Changes
Other Study ID Numbers: FG-778-02-60
Study First Received: September 12, 2005
Last Updated: April 15, 2008
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Directorate general for the protection of Public health: Medicines
Poland: Ministry of Health
Czech Republic: State Institute for Drug Control
United Kingdom: National Health Service
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Italy: Ministry of Health
Austria: Federal Ministry for Health and Women
Switzerland: Swissmedic

Keywords provided by Astellas Pharma Inc:
Treatment Efficacy
Treatment Effectiveness
Anti-rejection therapy
 Immunosuppression
Antirejection
Malononitrilamide

ClinicalTrials.gov processed this record on May 23, 2013