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FK778 vs Standard Regimen in Renal Transplant

NCT00189735Phase 2

Key facts

Status: Completed
Start: Sep 2003
Primary completion: Oct 2005
Countries: 12
Sponsor: Astellas Pharma
Modality: Small Molecules

Drugs: manitimus
Conditions: kidney transplant rejection

Overview

Phase 2, randomised, double-blind trial of manitimus in kidney transplant rejection (2 arms), sponsored by Astellas Pharma. Primary endpoint: Incidence of biopsy-proven acute rejection at 24 weeks. Started Sep 2003; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

FK778 Arm
FK778 + Tacrolimus + Steroids
Control Arm
MMF + Tacrolimus + Steroids

Who it enrols

Patients with end stage kidney disease or needing retransplantation. Excludes patients with high immunological risk, significant liver disease, donor kidney cold ischemia time >28 hours, or uncontrolled infections.

Endpoints

Primary

Incidence of biopsy-proven acute rejection24 weeks

Secondary

Incidence of biopsy-proven acute rejection1 year
Incidence of corticosteroid-resistant acute rejections1 year
Severity of biopsy-proven acute rejections (Banff criteria)1 year
Frequency of treatment failure1 year
Renal function (Serum creatinine and Creatinine clearance)1 year
Chronic Allograft Damage Index24 weeks
Patient survival1 year
Graft survival1 year

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