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.

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. - ATG induction in renal transplant patients with a NHBD kidney/NHBD-ATG

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30577

Enrollment

180

Registered

2007-08-03

Start date

2007-09-01

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

delayed graft function

Interventions

The intervention group receives an one-off ATG infusion during operation.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Primary parameter: incidence of DGF	—

Secondary

Measure	Time frame
Most important secundary parameters: duration of DGF; incidence of primary non-functioning kidneys; incidence of rejections; ultimate graft function.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)