Cyclosporine A Pretreatment and Kidney Graft Function

• Status: Recruiting
• Trial end date: 2022-09-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Centre Hospitalier Universitaire de Nice; Centre Hospitalier Universitaire de Nīmes; Groupe Hospitalier Pitie-Salpetriere; Hôpital de la Timone; Hôtel Dieu (Nantes); Poitiers University Hospital; University Hospital, Estaing; University Hospital, Montpellier; University Hospital, Toulouse
• Treatments: Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

For organ donors:

• Male and females aged 18 to 70 years

• Brain death

Inclusion criteria for organ recipients:

• Male and females aged 18 to 70 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