Status:
UNKNOWN
Anti-T-Lymphocyte Globulin (ATG) in Renal Transplantation of Kidneys With a Non-Heart-Beating (NHB) Donor
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Erasmus Medical Center
Maastricht University
Conditions:
Renal Transplant Patients
Recipients of a Kidney From a Non-Heart-Beating Donor
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 hig...
Eligibility Criteria
Inclusion
- Non-heart-beating-donors (Maastricht III/IV)
- Female patients of childbearing age agree to maintain effective birth control practice during the study.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00733733
Start Date
January 1 2008
End Date
June 1 2010
Last Update
August 13 2008
Active Locations (1)
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1
UMC St Radboud Hospital
Nijmegen, Netherlands, 6525 GA