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Completed

NCT Number: NCT00147381

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

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).

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Key information

Conditions

Kidney Transplantation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital Innsbruck

Innsbruck, Tyrol, 6020, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alemtuzumab

Drug

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

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

Other names: MABCAMPATH

Tacrolimus

Drug

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.

Other names: Prograf, Advagraf

Primary outcomes

  1. Biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification)

    Time frame: Month 6

Secondary outcomes

  1. Biopsy proven acute rejection episodes 12 months after transplantation (Banff Classification)

    Time frame: Year 1

  2. Time to 1st biopsy proven acute rejection episode (Banff Cl.)

    Time frame: Year 1

  3. Patient and graft survival

    Time frame: Year 1

  4. Number of patients who will get antilymphocyte preparation for treatment of steroid resistant acute rejection episodes

    Time frame: Year 1

  5. Treatment failure defined as change from immunosuppressive protocol because of biopsy proven intractable rejection

    Time frame: Year 1

  6. Adverse events (e.g. infections, PTLD)

    Time frame: Year 1

  7. Creatinine clearance

    Time frame: Year 1

Sponsors and collaborators

Lead sponsor

Dr. Claudia Bösmüller

Other

Collaborators

  • Astellas Pharma GmbH

Registry information

Official study 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 Transplantation

Important dates

Study start
2004
Primary completion
2008
Study completion
2011
First posted
Sep 7, 2005
Registry last updated
Jun 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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