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A Study to Evaluate FK778 in Kidney Transplant Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00189735
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : April 17, 2008
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients

Condition or disease Intervention/treatment Phase
Kidney Transplantation Renal Transplantation Transplantation, Renal Transplantation, Kidney Grafting, Kidney Drug: FK778 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : September 2003
Primary Completion Date : October 2005
Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

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

Secondary Outcome Measures :
  1. Efficacy:Incidence of and time to first biopsy-proven acute rejection over the first 24 weeks and after 1 year
  2. Incidence of and time to first corticosteroid-resistant acute rejections over the first 24 weeks and after 1 year
  3. Incidence of and time to first acute rejection by signs and symptoms over the first 24 weeks and after 1 year
  4. Severity of biopsy-proven acute rejections (Banff criteria) over the first 24 weeks and after 1 year
  5. Frequency of treatment failure (as defined below) over the first 24 weeks and after 1 year
  6. Renal function as measured by serum creatinine concentrations and calculated creatinine clearance (Cockcroft formula) over the first 24 weeks and after 1 year
  7. Chronic allograft dysfunction assessed by chronic allograft damage index (CADI) after 24 weeks of transplantation.
  8. Safety first 24 weeks: Patient survival
  9. Graft survival
  10. Incidence of adverse events
  11. Routine safety laboratory parameters
  12. Haemoglobin values at weeks two to six
  13. Leukocytes at weeks two to six
  14. Thrombocytes at weeks two to six
  15. Bilirubin at weeks two to six
  16. Incidence of CMV viraemia
  17. Incidence of Diarrhoea, Gastroenteritis and Gastritis
  18. Safety after 1 year:Incidence of adverse events
  19. Patient and graft survival

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00189735     History of Changes
Other Study ID Numbers: FG-778-02-60
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: April 17, 2008
Last Verified: April 2008

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