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OSAKA: Advagraf vs Prograf in Kidney Transplant

NCT00717470Phase 4

Key facts

Status: Completed
Start: May 2008
Primary completion: Mar 2010
Countries: 22
Sponsor: Astellas Pharma
Modality: Orthosteric Ligands

Drugs: tacrolimus + Wuzhi capsule
Conditions: kidney transplant rejection

Overview

Phase 4, randomised, open-label trial of tacrolimus + Wuzhi capsule in kidney transplant rejection (4 arms), sponsored by Astellas Pharma. Primary endpoint: Efficacy failure rate (Graft loss, Biopsy confirmed acute rejection, Graft dysfunction) at 24 weeks. Started May 2008; status: completed.

Design

4 arms

Study design: RandomizedOpen-label

Prograf Control
Prograf (0.2 mg/kg/day) + MMF + Steroids
Advagraf Low Dose
Advagraf (0.2 mg/kg/day) + MMF + Steroids
Advagraf High Dose
Advagraf (0.3 mg/kg/day) + MMF + Steroids
Advagraf + Induction
Advagraf (0.2 mg/kg/day) + MMF + Basiliximab + Steroids

Who it enrols

Patients with end stage kidney disease suitable for primary renal transplantation from a cadaveric or living donor. Excludes patients with significant liver disease, HIV, or those requiring other immunosuppressive therapy.

Endpoints

Primary

Efficacy failure rate (Graft loss, Biopsy confirmed acute rejection, Graft dysfunction)24 weeks

Secondary

Renal Function24 weeks
Acute rejection24 weeks
Biopsy confirmed acute rejection24 weeks

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