CompletedPhase 4

Cyclosporine a Pretreatment and Kidney Graft Function

France648 participantsStarted 2017-12-19

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of delayed graft function defined by a need of at least one hemodialysis session

Timeframe: within the 7 days following renal transplantation.

Trial details

NCT IDNCT02907554

SponsorUniversity Hospital, Clermont-Ferrand

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-10

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