A Study to Evaluate FK778 in Kidney Transplant Patients

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

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

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.