drugset / Trial / NCT02435732

CINRYZE as a Donor Pre-treatment Strategy in Kidney Recipients of KDPI>60%

NCT02435732

RandomizedParallel-groupTriple-blindTreatment

Summary

Limiting brain death-induced organ injury through a systemic anti- inflammatory medical management should allow for improvement in the quality of transplanted organs, and as a result, clinical improvement in post-transplant outcomes represented by a decrease in the incidence of delayed graft function (DGF) after transplantation. The specific aim is to evaluate the effect of C1INH (CINRYZE) as a donor pre-treatment strategy to decrease systemic inflammation and decrease the incidence of DGF in Expanded Criteria Donors (ECD), currently identified as donors with Kidney Donor Profile Index (KDPI) greater than or equal to 60%.

Timeline

Start
2020-12
Primary completion
2021-05
Completion
2022-05

Drugs

EvaluationDrugModalityDoseRoute
Subject CINRYZE Protein / enzyme biologic 200 iu/kg Intravenous
Subject CINRYZE Protein / enzyme biologic 500 iu/kg Intravenous
Subject Heparin Other / unclassified 20 iu/kg Intravenous

Indications