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Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection

NCT00147381 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2012-06-19

No results posted yet for this study

Summary

The purpose of this study is to determine whether Campath following Tacrolimus monotherapy is more effective in the prevention of renal graft rejection (considering an acute rejection rate of 5% for Campath-1H/Tacrolimus and of 22% for Tacrolimus/MMF/Steroids).

Conditions

  • Kidney Transplantation

Interventions

DRUG

Alemtuzumab

Day 0: Campath-1H 20 mg IV infusion over 3-6 hours Day 1: Campath-1H 20 mg IV infusion over 3-6 hours

DRUG

Tacrolimus

Day 0: Tacrolimus will be given pre-operatively or immediately post transplant surgery. The recommended initial daily starting dose is 0,1 mg/kg/d orally (0,05 mg/kg/bid) to aim at a whole blood level of 8-12 ng/ml. till Month 6: Aim at blood level of 8-12 ng/ml (try to prevent the Tacrolimus trough level falling below 10 ng/ml in the first 3 months). Month 7-12: Maintain the Tacrolimus blood level at 5-8 ng/ml after 6 months.

DRUG

Alemtuzumab

Day 0: Campath-1H 30 mg IV infusion over 3-6 hours Day 1: Campath-1H 30 mg IV infusion over 3-6 hours

Sponsors & Collaborators

  • Astellas Pharma GmbH

    collaborator INDUSTRY

  • Dr. Claudia Bösmüller

    lead OTHER

Principal Investigators

  • Raimund Margreiter, Prof. Dr. · Medical University for Surgery and Transplantation, Innsbruck

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2008-08-31
Completion
2011-07-31

Countries

  • Austria

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 NCT00147381 on ClinicalTrials.gov