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Completed

NCT Number: NCT00189735

A Study to Evaluate FK778 in Kidney Transplant Patients

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

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Key information

Conditions

Kidney Transplantation Grafting, Kidney Renal Transplantation Transplantation, Kidney Transplantation, Renal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Innsbruck, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FK778

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Collaborators

  • Astellas Pharma Europe B.V.

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Sep 19, 2005
Registry last updated
Apr 17, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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