A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection

Summary

The primary objective is to assess the efficacy and safety of NPC-21 when administered prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seropositive donor.

Timeline

Start

2020-06-01

Primary completion

2022-11-02

Completion

2023-02-08

Outcome

Missed primary endpoint

paper NPC-21 was safe, but no significant efficacy difference was found between NPC-21 and placebo. PMID 40072882 ↗

Publications

• Results Ichimaru N, Natori Y, Alloway RR, Wojciechowski D, Castillo Almeida NE, Futamura K, Watanabe T, Nakagawa K, Egawa H; LionHeart21 Study Group. Phase 2, Randomized, Double-blind, Placebo-controlled Study of Fiztasovimab (NPC-21) for Kidney Transplant Recipients at High Risk of Cytomegalovirus Infection (LionHeart21). Transplantation. 2025 Jun 1;109(6):985-993. doi: 10.1097/TP.0000000000005260. Epub 2025 May 18.
• Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.

Drugs

Indications