Neuroanesthesia & neurocritical care

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

Intensive Care MedPublished Randomised controlled trial

An erratum to this article was published (Intensive Care Med, Mar 2026 ↗)

Primary result · DGFResult — go to the resultUnadjusted odds ratio 1.27 95% CI 0.83–1.95

Authors' 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.

Study context

Population
Brain-dead kidney donors and their kidney transplant recipientsmodified ITT analysis
Comparison
Cyclosporine 2.5 mg/kg vs glucose placebo infusion in brain-dead donors
  • Cyclosporinen = 238 donors/312 recipients
  • Placebon = 258 donors/331 recipientsreference
Primary endpoint
Delayed graft function (DGF): need for ≥1 hemodialysis within 7 days after kidney transplantation
Follow-up
7 days
Methodological detailsmulticentre, double-blind, placebo-controlled, Enrolment December 17, 2017 to March 3, 2023
  • Multicentre
  • Double-blind
  • Placebo-controlled
  • Enrolment December 17, 2017 to March 3, 2023

Primary result

DGF

Unadjusted odds ratio

1.27

95% CI 0.83–1.95

P = 0.28

Events by treatment group

Cyclosporine vs Placebo
unadjusted OR 1.27 (95% CI 0.83–1.95); P = 0.28

As reported in the abstract

Secondary outcomes

Early graft function and 1-year graft and recipient survival

No significant between-group differences

Original publication

Cyclosporine versus placebo pretreatment of brain-dead donors and kidney graft function (Cis-A-Rein trial): a multicenter, double-blind, randomized, controlled trial. Intensive Care Med. Published 8 January 2026. doi:10.1007/s00134-025-08265-6

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