Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection
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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 Drug: Tacrolimus |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 Transplantation |
- 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 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 ]
| Enrollment: | 197 |
| Study Start Date: | January 2004 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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. |
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
|
|
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. |
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:
|
|
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. |
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
|
Detailed 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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Austria | |
| University Hospital Innsbruck | |
| Innsbruck, Tyrol, Austria, 6020 | |
| Principal Investigator: | Raimund Margreiter, Prof. Dr. | Medical University for Surgery and Transplantation, Innsbruck |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Claudia Bösmüller, Dr. med., Medical University Innsbruck |
| ClinicalTrials.gov Identifier: | NCT00147381 History of Changes |
| Other Study ID Numbers: | TaCam 07_MC, DE-02-RG-121/Margreiter |
| Study First Received: | September 6, 2005 |
| Last Updated: | June 18, 2012 |
| Health Authority: | Austria: Federal Office for Safety in Health Care |
Keywords provided by Medical University Innsbruck:
|
Campath-1H Alemtuzumab Tacrolimus |
renal transplantation immunosuppression prevention of acute rejection |
Additional relevant MeSH terms:
|
Tacrolimus Campath 1G Alemtuzumab Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013