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| ID | Type | Description | Link |
|---|---|---|---|
| DE-02-RG-121/Margreiter |
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| Name | Class |
|---|---|
| Astellas Pharma GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Campath-1H 20 mg | Experimental | 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. |
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| Tacrolimus | Active Comparator | 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. |
|
| Campath-1H 30 mg | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification) | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Biopsy proven acute rejection episodes 12 months after transplantation (Banff Classification) | Year 1 | |
| Time to 1st biopsy proven acute rejection episode (Banff Cl.) | Year 1 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raimund Margreiter, Prof. Dr. | Medical University for Surgery and Transplantation, Innsbruck | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Innsbruck | Innsbruck | Tyrol | 6020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10589966 | Background | 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. doi: 10.1097/00007890-199911270-00032. | |
| 18510632 | Derived | Margreiter R, Klempnauer J, Neuhaus P, Muehlbacher F, Boesmueller C, Calne RY. Alemtuzumab (Campath-1H) and tacrolimus monotherapy after renal transplantation: results of a prospective randomized trial. Am J Transplant. 2008 Jul;8(7):1480-5. doi: 10.1111/j.1600-6143.2008.02273.x. |
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| ID | Term |
|---|---|
| D000074323 | Alemtuzumab |
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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. |
|
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| Alemtuzumab | Drug | Day 0: Campath-1H 30 mg IV infusion over 3-6 hours Day 1: Campath-1H 30 mg IV infusion over 3-6 hours |
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| Patient and graft survival |
| Year 1 |
| Number of patients who will get antilymphocyte preparation for treatment of steroid resistant acute rejection episodes | Year 1 |
| Treatment failure defined as change from immunosuppressive protocol because of biopsy proven intractable rejection | Year 1 |
| Adverse events (e.g. infections, PTLD) | Year 1 |
| Creatinine clearance | Year 1 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |