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Completed
NCT02907554
Cyclosporine A Pretreatment and Kidney Graft Function
Conditions: Brain Death, Kidney Transplantation
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE4
Enrollment: 648
Sponsor: University Hospital, Clermont-Ferrand
Location: CHU Clermont-Ferrand Clermont-Ferrand
Summary
Organ donors included in the study are randomized to a control group or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. Harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. According to the pretreatment of the transplant, delayed graft function during the first week was evaluated as well as kidney function at different timepoints and mortality during the first year after transplantation.
Eligibility Criteria
Inclusion Criteria:
For organ donors:
* Male and females aged 18 to 80 years
* Brain death
Inclusion criteria for organ recipients:
* Male and females aged 18 to 80 years
* Indication of kidney transplantation
* Informed consent
Exclusion Criteria:
For organ donors:
* Contra-indication for multiorgan procurement (infections, cancer, etc)
* Preexistent chronic renal failure.
* Refusal for organ procurement by the donor (confirmed by the French national register or reported by the next-of-kin).
Exclusion criteria for organ recipients:
* Need for a double kidney transplantation.
* Need for a multiorgan transplantation
Source: ClinicalTrials.gov (NCT02907554). StuddyBuddy aggregates publicly available trial information.