drugset / Trial / NCT02435732
CINRYZE as a Donor Pre-treatment Strategy in Kidney Recipients of KDPI>60%
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |