Status:
COMPLETED
A Study to Evaluate FK778 in Kidney Transplant Patients
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Astellas Pharma Europe B.V.
Conditions:
Kidney Transplantation
Renal Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients
Eligibility Criteria
Inclusion
- Patient has end stage kidney disease or needs retransplantation (loss of graft for non-immunological reasons).
- Patient has been fully informed.
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT00189735
Start Date
September 1 2003
End Date
October 1 2005
Last Update
April 17 2008
Active Locations (37)
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1
Innsbruck, Austria, 6020
2
Brussels, Belgium, 1070
3
Brussels, Belgium, 1200
4
Leuven, Belgium, 3000