Anti-T-Lymphocyte Globulin (ATG) in Renal Transplantation of Kidneys With a Non-Heart-Beating (NHB) Donor

Radboud University Medical Center

Status and phase: Unknown; Phase 3

Conditions: Recipients of a Kidney From a Non-Heart-Beating Donor; Renal Transplant Patients

Treatments: Drug: ATG Fresenius

Study type: Interventional

Funder types: Other

Identifiers

NCT00733733

Euro-NHB

Details and patient eligibility

About

One of the greatest problems in renal transplantation is the shortage of donor kidneys. Kidneys of non-heart-beating donors (NHB) are a possible solution, but transplantation is accompanied with a high percentage of acute renal failure, caused by ischemia-reperfusion injury. The increased ischemia-reperfusion injury results in an increased immune activation, which can lead to more injury of the kidney and additional acute rejections. The hypothesis of this trial is that ischemia-reperfusion injury can be diminished by ATG. ATG could have additional favourable effects. To investigate this half of the patients is treated with additional ATG to the standard immunosuppressive treatment. Calcineurin inhibitors are not diminished during the first days after transplantation to investigate whether ATG has special effects on ischemia-reperfusion injury.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnant or lactating women at the time of randomization.
• Patients and donors are ABO incompatible.
• Women having had >3 pregnancies (including abortions if no consistent data on PRA or anti-donor antibodies are available).
• Patients with hypersensibility to rabbit proteins, previous treatment with rabbit IgG, or known intolerance to any component of basal immunosuppression.
• Patients with leukocytes <3,000/mm3 and/or platelets <50,000/mm3 before initiation of transplant.
• Patients, who are HIV positive.
• Patients subjected to previous transplants or candidates for multiple transplants (e.g. SKP).
• Patients, who are unlikely to comply with the visit schedule in the protocol and patients who cannot communicate reliably with the investigator.
• Patients with pulmonary oedema or with other signs of overhydration.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

ATG

Active Comparator group

Description:

One gift of ATG Fresenius (9 mg/kg body weight) intravenously during the transplantation procedure. ATG is given in addition to standard immunosuppressive treatment (tacrolimus/MMF/prednisolone)

Treatment:

Drug: ATG Fresenius

Control

No Intervention group

Description:

Standard immunosuppressive treatment for renal transplantation including tacrolimus/MMF/prednisolone without ATG treatment.