Kidney Transplantation
Conditions
Keywords
Campath-1H, Alemtuzumab, Tacrolimus, renal transplantation, immunosuppression, prevention of acute rejection
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.
Interventions
DRUGAlemtuzumab
Day 0: Campath-1H 20 mg IV infusion over 3-6 hours Day 1: Campath-1H 20 mg IV infusion over 3-6 hours
DRUGTacrolimus
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.
Sponsors
Astellas Pharma GmbH
Dr. Claudia Bösmüller
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biopsy proven acute rejection episodes 6 months after transplantation (Banff Classification) | Month 6 |
Secondary
| Measure | Time frame |
|---|---|
| Time to 1st biopsy proven acute rejection episode (Banff Cl.) | Year 1 |
| Patient and graft survival | Year 1 |
| Number of patients who will get antilymphocyte preparation for treatment of steroid resistant acute rejection episodes | Year 1 |
| Biopsy proven acute rejection episodes 12 months after transplantation (Banff Classification) | Year 1 |
| Adverse events (e.g. infections, PTLD) | Year 1 |
| Creatinine clearance | Year 1 |
| Treatment failure defined as change from immunosuppressive protocol because of biopsy proven intractable rejection | Year 1 |
Countries
Austria
Outcome results
None listed