Anti-T-Lymphocyte Globulin (ATG) in Renal Transplantation of Kidneys With a Non-Heart-Beating (NHB) Donor
NCT ID: NCT00733733
Last Updated: 2008-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
180 participants
INTERVENTIONAL
2008-01-31
2010-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ATG
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)
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)
Control
Standard immunosuppressive treatment for renal transplantation including tacrolimus/MMF/prednisolone without ATG treatment.
No interventions assigned to this group
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* Female patients of childbearing age agree to maintain effective birth control practice during the study.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Erasmus Medical Center
OTHER
Maastricht University
OTHER
Leiden University Medical Center
OTHER
UMC Utrecht
OTHER
University Medical Center Groningen
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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UMC St Radboud Hospital
Principal Investigators
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andries hoitsma, prof.dr.
Role: PRINCIPAL_INVESTIGATOR
UMC St Radboud Hospital, Nijmegen, the Netherlands
Locations
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UMC St Radboud Hospital
Nijmegen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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andries hoitsma, prof. dr.
Role: primary
Luuk Hilbrands, Dr.
Role: backup
Other Identifiers
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Euro-NHB
Identifier Type: -
Identifier Source: org_study_id