A Study to Evaluate FK778 in Kidney Transplant Patients

• Status: Completed
• Trial end date: 2005-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma Europe B.V.

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.