Clinical Trial: Effectiveness and Safety of Campath in Combination with Tacrolimus Monotherapy to Prevent Kidney Graft Rejection

This study is no longer recruiting patients.

Sponsors and Collaborators: Medical University Innsbruck
Astellas Pharma GmbH
Information provided by: Medical University Innsbruck
ClinicalTrials.gov Identifier: NCT00147381

Purpose

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).
Condition Intervention Phase
Kidney Transplantation
 Drug: Alemtuzumab
Phase III

MedlinePlus consumer health information 

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title: Effectiveness and Safety of Campath-1H as an Induction Agent in Combination with Tacrolimus Monotherapy for Prevention of Graft Rejection Compared to Tacrolimus in Combination with MMF and Steroids in Cadaveric Kidney Transplantion

Further Study Details: 
Primary Outcomes: biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification)
Secondary Outcomes: - biopsy proven acute rejection episodes 12 months after Transplantation (Banff Cl.); - time to 1st biopsy proven acute rejection episode (Banff Cl.); - patient and graft survival; - number of patients who will get antilymphocyte preparation for treatment of steroid resistant acute rejection episodes; - treatment failure defined as change from immunosuppressive protocol because of biopsy proven intractable rejection; - adverse events (e.g. infections, PTLD); - creatinine clearance
Expected Total Enrollment:  130

Study start: January 2004;  Study completion: January 2007
Last follow-up: July 2006;  Data entry closure: October 2006

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 observative 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.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • age 18-65
  • endstage renal failure with no previous renal transplantation
  • cadaveric donor
  • written informed consent

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

Location Information


Austria
      Medical University for Surgery and Transplantation, Innsbruck,  6020,  Austria

Study chairs or principal investigators

Raimund Margreiter, Prof. Dr.,  Principal Investigator,  Medical University for Surgery and Transplantation, Innsbruck   

More Information

Publications

Calne R, Moffatt SD, Friend PJ, Jamieson NV, Bradley JA, Hale G, Firth J, Bradley J, Smith KG, Waldmann H. Campath IH allows low-dose cyclosporine monotherapy in 31 cadaveric renal allograft recipients. Transplantation. 1999 Nov 27;68(10):1613-6.

Study ID Numbers:  TaCam 06_MC; DE-02-RG-121/Margreiter
Last Updated:  September 6, 2005
Record first received:  September 6, 2005
ClinicalTrials.gov Identifier:  NCT00147381
Health Authority: Austria: Federal Ministry for Health and Women
ClinicalTrials.gov processed this record on 2005-09-13

Resources




Common Treatments

[ Disclaimer: The information on GoldBamboo for any particular treatment, medicine, drug, or herbal product might be missing or incomplete, and should never be used as a single source of knowledge. GoldBamboo generally has links to authoritative sites displayed toward the bottom of each topic page under the heading "Resources". ]

Follow Us