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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma GmbH
Information provided by (Responsible Party):
Dr. Claudia Bösmüller, Medical University Innsbruck
ClinicalTrials.gov Identifier:
NCT00147381
First received: September 6, 2005
Last updated: June 18, 2012
Last verified: June 2012

September 6, 2005
June 18, 2012
January 2004
August 2008   (final data collection date for primary outcome measure)
Biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification) [ Time Frame: Month 6 ] [ Designated as safety issue: Yes ]
biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification)
Complete list of historical versions of study NCT00147381 on ClinicalTrials.gov Archive Site
  • Biopsy proven acute rejection episodes 12 months after transplantation (Banff Classification) [ Time Frame: Year 1 ] [ Designated as safety issue: Yes ]
  • Time to 1st biopsy proven acute rejection episode (Banff Cl.) [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Patient and graft survival [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Number of patients who will get antilymphocyte preparation for treatment of steroid resistant acute rejection episodes [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Treatment failure defined as change from immunosuppressive protocol because of biopsy proven intractable rejection [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Adverse events (e.g. infections, PTLD) [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • Creatinine clearance [ Time Frame: Year 1 ] [ Designated as safety issue: No ]
  • - 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
Not Provided
Not Provided
 
Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection
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

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).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Kidney Transplantation
  • 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

    Other Name: MABCAMPATH
  • 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.

    Other Names:
    • Prograf
    • Advagraf
  • 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

    Other Name: MABCAMPATH
  • Experimental: Campath-1H 20 mg

    Day 0: Immediately post transplant surgery patients will receive methylprednisolone 250 mg IV followed one hour later by Campath-1H 20 mg IV infusion over 3-6 hours.

    Day 1: Same protocol of Campath-1H and methylprednisolone as on Day 0.

    Day 2: No treatment

    Day 3: Initial dose of Tacrolimus 0,1 mg/kg/d (0,05 mg/kg/bid)

    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.

    Intervention: Drug: Alemtuzumab
  • Active Comparator: Tacrolimus

    Day 0: Immediately post transplant surgery patients will receive methylprednisolone 250 mg IV followed one hour later by Campath-1H 30 mg IV infusion over 3-6 hours.

    Day 1: No treatment

    Day 2: Initial dose Tacrolimus 0.1 mg/kg/d (0.05 mg/kg.bid).

    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.

    Intervention: Drug: Tacrolimus
  • Experimental: Campath-1H 30 mg

    Day 0: Immediately post transplant surgery patients will receive methylprednisolone 250 mg IV followed one hour later by Campath-1H 30 mg IV infusion over 3-6 hours.

    Day 1: No treatment.

    Day 2: Initial dose Tacrolimus 0.1 mg/kg/d (0.05 mg/kg.bid).

    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.

    Intervention: Drug: Alemtuzumab

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
197
July 2011
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00147381
TaCam 07_MC, DE-02-RG-121/Margreiter
No
Dr. Claudia Bösmüller, Medical University Innsbruck
Dr. Claudia Bösmüller
Astellas Pharma GmbH
Principal Investigator: Raimund Margreiter, Prof. Dr. Medical University for Surgery and Transplantation, Innsbruck
Medical University Innsbruck
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP