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

Last updated: June 18, 2012
Sponsor: Dr. Claudia Bösmüller
Overall Status: Completed

Phase

3

Condition

Kidney Transplantation

Treatment

N/A

Clinical Study ID

NCT00147381
TaCam 07_MC
DE-02-RG-121/Margreiter
  • Ages 18-65
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age 18-65

  • endstage renal failure with no previous renal transplantation

  • cadaveric donor

  • written informed consent

Exclusion

Exclusion Criteria:

  • pregnant or nursing women

  • multi-organ transplant recipients

  • live donor recipients

  • re-transplants

  • panel reactive antibodies (PRA) > 25%

  • previous treatment with Campath-1H

  • use of other investigational agents within 6 weeks

  • active systemic infection

  • HIV positive patient or donor

  • positive lymphocyte cytotoxicity cross-match between recipient serum and donor cells

  • past history of anaphylaxis following exposure to humanized monoclonal antibodies

Study Design

Total Participants: 197
Study Start date:
January 01, 2004
Estimated Completion Date:
July 31, 2011

Study Description

Major advances in immunosuppressive therapy have resulted in long-term graft survival by the use of various drug combinations.However, these combinations carry the risk of e.g. infection, malignancy, renal damage, hypertension, diabetes, hyperlipidemia, hirsutism, cushingoid facial appearance and bone necrosis.Therefore one of the major goals should be to reduce immunosuppression without increasing risk of rejections.

Based on good results of a pilot study (not a single acute rejection episode during the 18-20 months observation period despite low level of Tacrolimus and absence of steroids) this randomised trial was designed to further evaluate the safety and efficacy of Campath-1H.

Connect with a study center

  • University Hospital Innsbruck

    Innsbruck, Tyrol 6020
    Austria

    Site Not Available

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