Effectiveness and Safety of Campath in Combination With Tacrolimus Monotherapy to Prevent Kidney Graft Rejection - Full Text View

Sponsors and Collaborators:	Medical University Innsbruck Astellas Pharma GmbH
Information provided by:	Medical University Innsbruck
ClinicalTrials.gov Identifier:	NCT00147381

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	Phase III

MedlinePlus related topics: Kidney Transplantation

Drug Information available for: Tacrolimus Alemtuzumab Campath Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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 Transplantion

Further study details as provided by Medical University Innsbruck:

Primary Outcome Measures:

biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification)

Secondary Outcome Measures:

- biopsy proven acute rejection episodes 12 months after Transplantation (Banff Cl.)
- time to 1st biopsy proven acute rejection episode (Banff Cl.)
- patient and graft survival
- number of patients who will get antilymphocyte preparation for treatment of steroid resistant acute rejection episodes
- treatment failure defined as change from immunosuppressive protocol because of biopsy proven intractable rejection
- adverse events (e.g. infections, PTLD)
- creatinine clearance

Estimated Enrollment:	130
Study Start Date:	January 2004
Estimated Study Completion Date:	July 2006

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147381

Locations

Austria
Medical University for Surgery and Transplantation
Innsbruck, Austria, 6020

Sponsors and Collaborators

Medical University Innsbruck

Astellas Pharma GmbH

Investigators

Principal Investigator:

Raimund Margreiter, Prof. Dr.

Medical University for Surgery and Transplantation, Innsbruck

More Information

Publications:

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.

Publications indexed to this study:

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.

Study ID Numbers:	TaCam 06_MC, DE-02-RG-121/Margreiter
Study First Received:	September 6, 2005
Last Updated:	November 21, 2005
ClinicalTrials.gov Identifier:	NCT00147381
Health Authority:	Austria: Federal Ministry for Health and Women

Keywords provided by Medical University Innsbruck:

Campath-1H
Alemtuzumab
Tacrolimus

renal transplantation
immunosuppression
prevention of acute rejection

Study placed in the following topic categories:

Alemtuzumab
Tacrolimus

Additional relevant MeSH terms:

Immunologic Factors
Antineoplastic Agents
Therapeutic Uses

Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009