A Study to Evaluate FK778 in Kidney Transplant Patients

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


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

  Show 37 Study Locations
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Europe B.V.
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: Federal Agency for Medicines and Health Products, FAMHP
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 April 20, 2014