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

Kidney Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147381
• Other study ID #: TaCam 07_MC
• Secondary ID: DE-02-RG-121/Mar
• Status: Completed
• Phase: Phase 3
• First received: September 6, 2005
• Last updated: June 18, 2012
• Start date: January 2004
• Est. completion date: July 2011

Study information

• Verified date: June 2012
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: July 2011
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• 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
• 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.
• 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

Locations

Country	Name	City	State
Austria	University Hospital Innsbruck	Innsbruck	Tyrol

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Claudia Bösmüller	Astellas Pharma GmbH

Country where clinical trial is conducted

Austria, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification)		Month 6	Yes
Secondary	Biopsy proven acute rejection episodes 12 months after transplantation (Banff Classification)		Year 1	Yes
Secondary	Time to 1st biopsy proven acute rejection episode (Banff Cl.)		Year 1	No
Secondary	Patient and graft survival		Year 1	No
Secondary	Number of patients who will get antilymphocyte preparation for treatment of steroid resistant acute rejection episodes		Year 1	No
Secondary	Treatment failure defined as change from immunosuppressive protocol because of biopsy proven intractable rejection		Year 1	No
Secondary	Adverse events (e.g. infections, PTLD)		Year 1	No
Secondary	Creatinine clearance		Year 1	No