Clinical trial NCT00147381: Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Keywords: Campath-1H
Alemtuzumab
Tacrolimus
renal transplantation
immunosuppression
prevention of acute rejection
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
Collaborators: name: Astellas Pharma GmbH
First posted: 2005-09-07
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).

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 criteria: 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

Primary outcomes:
measure: Biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification)
timeFrame: Month 6
Secondary outcomes:
measure: Biopsy proven acute rejection episodes 12 months after transplantation (Banff Classification)
timeFrame: Year 1
measure: Time to 1st biopsy proven acute rejection episode (Banff Cl.)
timeFrame: Year 1
measure: Patient and graft survival
timeFrame: Year 1
measure: Number of patients who will get antilymphocyte preparation for treatment of steroid resistant acute rejection episodes
timeFrame: Year 1
measure: Treatment failure defined as change from immunosuppressive protocol because of biopsy proven intractable rejection
timeFrame: Year 1
measure: Adverse events (e.g. infections, PTLD)
timeFrame: Year 1
measure: Creatinine clearance
timeFrame: Year 1
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: University Hospital Innsbruck
state: Tyrol
Study officials:
affiliation: Medical University for Surgery and Transplantation, Innsbruck
name: Raimund Margreiter, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.