A Study to Evaluate FK778 in Kidney Transplant Patients

Phase 2

Completed

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

• Registration Number: NCT00189735
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-15
• Last Update Posted: 2008-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 364

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of biopsy-proven acute rejection over the first 24 weeks.

Secondary Outcome Measures

Name	Time	Method
Efficacy:Incidence of and time to first biopsy-proven acute rejection over the first 24 weeks and after 1 year
Incidence of and time to first corticosteroid-resistant acute rejections over the first 24 weeks and after 1 year
Incidence of and time to first acute rejection by signs and symptoms over the first 24 weeks and after 1 year
Severity of biopsy-proven acute rejections (Banff criteria) over the first 24 weeks and after 1 year
Frequency of treatment failure (as defined below) over the first 24 weeks and after 1 year
Renal function as measured by serum creatinine concentrations and calculated creatinine clearance (Cockcroft formula) over the first 24 weeks and after 1 year
Chronic allograft dysfunction assessed by chronic allograft damage index (CADI) after 24 weeks of transplantation.
Incidence of adverse events
Routine safety laboratory parameters
Haemoglobin values at weeks two to six
Safety first 24 weeks: Patient survival
Graft survival
Leukocytes at weeks two to six
Thrombocytes at weeks two to six
Bilirubin at weeks two to six
Incidence of CMV viraemia
Incidence of Diarrhoea, Gastroenteritis and Gastritis
Safety after 1 year:Incidence of adverse events
Patient and graft survival