Cyclosporine a Pretreatment and Kidney Graft Function (Cis-A-Rein)

University Hospital, Clermont-Ferrand

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation; Brain Death

Treatments: Drug: Placebo; Drug: cyclosporine A

Study type: Interventional

Funder types: Other

Identifiers

NCT02907554

RBHP_2014_CONSTANTIN

2014-003544-12 (Other Identifier)

Details and patient eligibility

About

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.

Full description

Organ donors included in the study are randomized to a control group receiving a placebo or an intervention group receiving 2.5 mg/kg of cyclosporine A before organ procurement. In the operating theater organs are harvested. Thereafter, harvested kidneys from these patients are transplanted to chronic kidney insufficiency patients. The management of transplanted patients is performed as usual. According to the pretreatment of the transplant, delayed graft function during the first week (need of at least one dialysis session) was evaluated as well as kidney function at different timepoints (slow graft function, estimated creatinine clearance on day 3 and 7, acute and chronic graft rejection), length of hospital stay and mortality during the first year after transplantation.

Enrollment: 648 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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648 participants in 2 patient groups, including a placebo group

control group

Placebo Comparator group

Description:

control group receives a placebo

Treatment:

Drug: Placebo

intervention group

Experimental group

Description:

the intervention group receives 2.5 mg/kg of cyclosporine

Treatment:

Drug: cyclosporine A