Cyclosporine versus placebo pretreatment of brain-dead donors and kidney graft function (Cis-A-Rein trial): a multicenter, double-blind, randomized, controlled trial.

PURPOSE: Delayed graft function is the most frequent early complication of kidney transplantation. Pretreatment of kidney donors with cyclosporine has decreased delayed graft function in animal studies by reducing ischemia-reperfusion graft injuries. No randomized clinical trials have assessed the efficacy of cyclosporine pretreatment of brain-dead donors in reducing delayed graft function.

METHODS

In this multicenter randomized, double-blind, and placebo-controlled trial, brain-dead donors were randomized (1:1) to receive either 2.5 mg/kg of cyclosporine or a glucose placebo infusion. The kidney transplant candidates were allocated through their donor assignment. The primary outcome was the occurrence of delayed graft function (DGF), defined as the need for at least one hemodialysis within the 7 days after kidney transplantation. Secondary outcomes included early graft function parameters within the 7 days post-transplantation, and 1-year graft and recipient survival.

RESULTS

Between December 17, 2017 and March 3, 2023, 258 donors/331 recipients in the placebo group and 238 donors/312 recipients in the cyclosporine group were included in the modified intention-to-treat analysis. DGF occurred in 46 recipients (13.9%) in the placebo group and in 53 recipients (17.0%) in the cyclosporine group (unadjusted odd ratio = 1·27, 95% CI 0.83-1.95, P = 0.28). No significant between-group differences in the secondary outcomes (early graft function and 1-year graft and recipient survival) were observed.

CONCLUSION

In this double-blind, randomized controlled clinical trial, a pretreatment of brain-dead donors with a single low dose of cyclosporine did not significantly reduce the occurrence of DGF in kidney transplant recipients.