A Study to Evaluate FK778 in Kidney Transplant Patients

Phase 2CompletedNCT00189735

Astellas Pharma Inc364 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

364

Conditions

Kidney Transplantation Renal Transplantation Transplantation, Renal Transplantation, Kidney Grafting, Kidney

Interventions

FK778DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (37)

Unnamed facility

Innsbruck, Austria

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Safety first 24 weeks: Patient survival

Graft survival

Incidence of adverse events

Routine safety laboratory parameters

Haemoglobin values at weeks two to six

Leukocytes at weeks two to six

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.