NCT00617604

A Study to Assess the Efficacy and Safety of Alefacept in Kidney Transplant Recipients

Efficacy and Safety of Alefacept in Combination With Tacrolimus, Mycophenolate Mofetil and Steroids in de Novo Kidney Transplantation - a Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 218 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether alefacept is effective and well tolerated when used with a combination of tacrolimus, mycophenolate mofetil and steroids versus a combination therapy of placebo, tacrolimus and steroids in the prevention of kidney transplant rejection.

Conditions

• De Novo Kidney Transplantation

Interventions

Type	Name	Description
DRUG	Alefacept	IV and subcutaneous injection
DRUG	placebo	IV and subcutaneous injection
DRUG	Tacrolimus	The initial daily dose was 0.2 mg/kg orally given in 2 doses commencing 24 hours after completion of surgery.
DRUG	Mycophenolate Mofetil	Mycophenolic mofetil was administered as 750 mg twice per day orally
DRUG	Steroids	Methylprednisolone or equivalent: Day 0: 500 - 1000 mg IV bolus Day 1: 125 - 250 mg IV bolus Prednisone or equivalent: Days 2 - 14: 20 - 30 mg orally Days 15 - 28: 10 - 20 mg orally Days 29 - 60: 10 - 15 mg orally Days 61 onwards: 5 - 10 mg orally

Timeline

• Start date: 2007-12-01
• Primary completion: 2009-09-01
• Completion: 2009-09-01
• First posted: 2008-02-18
• Last updated: 2016-02-04
• Results posted: 2016-02-04

Locations

33 sites across 12 countries: Austria, Belgium, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom