Anti-T-Lymphocyte Globulin (ATG) in Renal Transplantation of Kidneys With a Non-Heart-Beating (NHB) Donor
- Conditions
- Renal Transplant PatientsRecipients of a Kidney From a Non-Heart-Beating Donor
- Interventions
- Registration Number
- NCT00733733
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 180
- Non-heart-beating-donors (Maastricht III/IV)
- Female patients of childbearing age agree to maintain effective birth control practice during the study.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ATG ATG Fresenius 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)
- Primary Outcome Measures
Name Time Method Incidence of initial delayed graft function (defined as need for dialysis) Within three months after transplantation
- Secondary Outcome Measures
Name Time Method Duration of initial delayed graft failure Within 3 months after transplantation Incidence of primary never-functioning grafts Within 3 months after transplantation Incidence of acute rejections (biopsy proven) Within 3 months after transplantation Renal function as determined by MDRD At 1, 2, 3 months after transplantation Proteinuria At 1, 2, 3 months after transplantation Percentage of patients with arterial hypertension At 3 months after transplantation Percentage of patients with antihypertensive drugs (and the number of different classes of antihypertensive drugs) At 3 months after transplantation Percentage of hyperlipidemic patients At 3 months after transplantation Percentage of post transplant diabetes mellitus During 3 months after transplantation Incidence of cytomegalovirus infection During 3 months after transplantation Incidence of tumours/PTLD At 3 months after transplantation Patient and graft survival At 3 months after transplantation Incidence of other infections During 3 months after transplantation Microalbuminuria At 1, 2, 3 months after transplantation
Trial Locations
- Locations (1)
UMC St Radboud Hospital
🇳🇱Nijmegen, Netherlands