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

Radboud University Medical Center180 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

180

Conditions

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

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of initial delayed graft function (defined as need for dialysis)

Time frame: Within three months after transplantation

Secondary Outcomes

Duration of initial delayed graft failure

Time frame: Within 3 months after transplantation

Incidence of primary never-functioning grafts

Time frame: Within 3 months after transplantation

Incidence of acute rejections (biopsy proven)

Time frame: Within 3 months after transplantation

Renal function as determined by MDRD

Time frame: At 1, 2, 3 months after transplantation

Proteinuria

Time frame: At 1, 2, 3 months after transplantation

Percentage of patients with arterial hypertension