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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2011-07-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Kidney Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Alemtuzumab

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Tacrolimus

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Alemtuzumab

Intervention Type 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

Interventions

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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

Intervention Type 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.

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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MABCAMPATH Prograf Advagraf MABCAMPATH

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No