A Study to Evaluate FK778 in Kidney Transplant Patients

Astellas

Status and phase: Completed; Phase 2

Conditions: Transplantation, Kidney; Kidney Transplantation; Grafting, Kidney; Transplantation, Renal; Renal Transplantation

Treatments: Drug: FK778

Study type: Interventional

Funder types: Industry

Identifiers

NCT00189735

FG-778-02-60

Details and patient eligibility

About

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

Enrollment: 364 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind