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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 21, 2014