A prospective, randomized, open, multicenter study to evaluate the efficacy and tolerability of induction therapy with a single high-dose anti-T-lymphocyte globulin (ATG-Fresenius) in renal transplant patients with a kidney from a non-heart-beating donor and tacrolimus, mycophenolate mofetil, and steroids as basic immunosuppression.
- Conditions
- 10038430delayed graft functionacute rejction
- Registration Number
- NL-OMON30577
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 180
Patients will receive information related to the clinical trial and have to give written informed consent.;1. Non-heart-beating-donors (Maastricht III/IV)
2. Female patients of childbearing age agree to maintain effective birth control practice during the study.
1. Pregnant or lactating women at the time of randomization.
2. Patients and donors are ABO incompatible.
3. Women having had >3 pregnancies (including abortions if no consistent data on PRA or anti-donor antibodies are available).
4. Patients with hypersensibility to rabbit proteins, previous treatment with rabbit IgG, or known intolerance to any component of basal immunosuppression.
5. Patients with leukocytes <3,000/mm3 and/or platelets <50,000/mm3 before initiation of transplant.
6. Patients, who are HIV positive.
7. Patients, who are candidates for multiple transplants (e.g. SKP).
8. Patients, who are unlikely to comply with the visit schedule in the protocol and patients who cannot communicate reliably with the investigator.
9. Patients with pulmonary oedema or with other signs of overhydration.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method