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

NCT00617604 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2016-02-04

Study results available
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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

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

Sponsors & Collaborators

  • Astellas Pharma Inc

    lead INDUSTRY

Principal Investigators

  • Central Contact · Astellas Pharma Europe B.V.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Austria
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00617604 on ClinicalTrials.gov