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) in Renal Transplant Patients With a Kidney From a Non-Heart-Beating Donor and Tacrolimus, Mycophenolate Mofetil, and Steroids as Basic Immunosuppression.
18 Years
N/A
Both
Renal Transplant Patients, Recipients of a Kidney From a Non-Heart-Beating Donor
Trial Information
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) in Renal Transplant Patients With a Kidney From a Non-Heart-Beating Donor and Tacrolimus, Mycophenolate Mofetil, and Steroids as Basic Immunosuppression.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of initial delayed graft function (defined as need for dialysis)
Outcome Time Frame:
Within three months after transplantation
Safety Issue:
No
Principal Investigator
andries hoitsma, prof.dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
UMC St Radboud Hospital, Nijmegen, the Netherlands
Authority:
Netherlands: Medical Ethics Review Committee (METC)
Study ID:
Euro-NHB
NCT ID:
NCT00733733
Start Date:
January 2008
Completion Date:
June 2010
Related Keywords:
- Renal Transplant Patients
- Recipients of a Kidney From a Non-Heart-Beating Donor
- kidney
- transplantation
- non-heart-beating donor
- delayed graft function
- Antithymocyte globulin
- ischemia-reperfusion damage
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