Renal Ex Vivo SYN002 Perfusion to Eliminate CMV Transmission

Summary

Donor organs often carry latent Cytomegalovirus (CMV) infection that may be transmitted to the recipient. The goal of this clinical trial is to determine the safety of SYN002 treatment during Ex-Vivo Organ Perfusion (EVOP) in clinical kidney transplantation. Donor kidneys will be treated on the EVOP system with SYN002 in order to decrease the burden of latent CMV in the organ and mitigate the transmission of cytomegalovirus (CMV).

Timeline

Start

2026-03-16

Primary completion

2027-03-16

Completion

2027-12-31

Publications

• Background Ribeiro RVP, Ku T, Wang A, Pires L, Ferreira VH, Michaelsen V, Ali A, Galasso M, Moshkelgosha S, Gazzalle A, Jeppesen MG, Rosenkilde MM, Liu M, Singer LG, Kumar D, Keshavjee S, Sinclair J, Kledal TN, Humar A, Cypel M. Ex vivo treatment of cytomegalovirus in human donor lungs using a novel chemokine-based immunotoxin. J Heart Lung Transplant. 2022 Mar;41(3):287-297. doi: 10.1016/j.healun.2021.10.010. Epub 2021 Oct 25.
• Background Kotton CN, Kumar D, Manuel O, Chou S, Hayden RT, Danziger-Isakov L, Asberg A, Tedesco-Silva H, Humar A; Transplantation Society International CMV Consensus Group. The Fourth International Consensus Guidelines on the Management of Cytomegalovirus in Solid Organ Transplantation. Transplantation. 2025 Jul 1;109(7):1066-1110. doi: 10.1097/TP.0000000000005374. Epub 2025 Apr 9. No abstract available.

Drugs

Indications