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. - NHB-ATG

Conditions: Transplantation of a renal graft from a non-heart-beating donor

Registration Number: EUCTR2007-000210-36-NL

Lead Sponsor: MC St Radboud University Hospital Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. Non-heart-beating-donors (Maastricht III/IV)
2. Female patients of childbearing age agree to maintain effective birth control practice during the study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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 subjected to previous transplants or 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 clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Main objective of this study is to compare the efficacy and tolerability of polyclonal antibody as induction therapy vs. no antibody induction, with special regard to the incidence of initial delayed graft function.<br><br>;Primary end point(s): Incidence of initial DGF (defined as the need for dialysis after transplantation).;Secondary Objective: The main secondary objectives of the trial are:<br>- the duration of initial DGF <br>- Incidence of primary non-functioning grafts.<br>- Acute rejection (biopsy proven):<br>- overall incidence and time until first manifestation<br>- histopathological severity (BANFF)<br>- incidence of subclinical rejection <br>- Renal function as determined by creatinine clearance (MDRD) at 1, 2, and 3 months.<br>

Secondary Outcome Measures