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

Dr. Claudia Bösmüller

Status and phase: Completed; Phase 3

Conditions: Kidney Transplantation

Treatments: Drug: Alemtuzumab; Drug: Tacrolimus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00147381

DE-02-RG-121/Margreiter

TaCam 07_MC

Details and patient eligibility

About

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).

Full 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.

Enrollment: 197 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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197 participants in 3 patient groups

Campath-1H 20 mg

Experimental group

Description:

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.

Treatment:

Drug: Alemtuzumab

Drug: Alemtuzumab

Tacrolimus

Active Comparator group

Description:

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.

Treatment:

Drug: Tacrolimus

Campath-1H 30 mg

Experimental group

Description:

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.

Treatment:

Drug: Alemtuzumab

Drug: Alemtuzumab