Phase 2, Randomized, Double-blind, Placebo-controlled Study of Fiztasovimab (NPC-21) for Kidney Transplant Recipients
Naotsugu Ichimaru1, Yoichiro Natori2,3, Rita R Alloway4
1Department of Urology, Kinki Central Hospital, Hyogo, Japan.
Background:
Kidney transplantation (KT) has dramatically improved the quality of life of patients with end-stage kidney disease. However, the incidence of opportunistic infections has also increased because of immunosuppression. A common infection after KT is cytomegalovirus (CMV). In KT recipients, we assessed the efficacy and safety of fiztasovimab (NPC-21), an anti-CMV monoclonal antibody.
Methods:
This was a multicenter, randomized, double-blind, placebo-controlled, phase 2 study of NPC-21 for KT recipients with CMV donor-positive (D + )/recipient-negative (R - ) serostatus. Patients were randomly assigned to receive monthly 6 or 12 mg/kg NPC-21, or placebo, in a 4:1:4 ratio. The primary efficacy endpoint was CMV infection by week 16.
Results:
Eighty-seven KT recipients were randomized; 38, 11, and 38 received 6 mg/kg of NPC-21, 12 mg/kg of NPC-21, or placebo, respectively. CMV infections occurred in 29 of 38 (76.3%), 9 of 11 (81.8%), and 26 of 38 (68.4%) patients in the 6 mg/kg NPC-21, 12 mg/kg NPC-21, and placebo groups, respectively, with no statistically significant differences. CMV disease occurred in 2 of 49 (4.1%) versus 5 of 38 (13.2%) patients in the 6 and 12 mg/kg combined NPC-21 group versus the placebo group. The absolute difference (95% confidence interval) was -9.1 (-23.9 to 2.8). No significant adverse events were observed after NPC-21 administration.
Conclusions:
NPC-21 was safe, but no significant efficacy difference was found between NPC-21 and placebo. Severe CMV infection was less likely in the NPC-21 group versus the placebo group. Further studies are needed to elucidate the role of NPC-21 in the prevention of CMV.
Insights
Fiztasovimab (NPC-21) showed no significant efficacy in preventing cytomegalovirus (CMV) infections after kidney transplantation. While generally safe, further research is needed to determine its role in CMV prevention for transplant recipients.
Area of Science:
- Immunology
- Transplantation Medicine
- Infectious Diseases
Background:
- Kidney transplantation (KT) improves quality of life for end-stage kidney disease patients.
- Immunosuppression post-KT increases opportunistic infection risk, notably cytomegalovirus (CMV).
- Fiztasovimab (NPC-21) is an anti-CMV monoclonal antibody evaluated in KT recipients.
Purpose of the Study:
- To assess the efficacy and safety of fiztasovimab (NPC-21) in preventing CMV infection in kidney transplant recipients.
- To compare different dosages of NPC-21 against a placebo.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled phase 2 study.
- KT recipients with CMV donor-positive/recipient-negative serostatus were randomized to receive monthly 6 or 12 mg/kg NPC-21, or placebo (4:1:4 ratio).
- Primary endpoint was CMV infection by week 16.
Main Results:
- Eighty-seven patients were randomized. CMV infections occurred in 76.3% (6 mg/kg NPC-21), 81.8% (12 mg/kg NPC-21), and 68.4% (placebo) with no significant difference.
- Severe CMV disease was less frequent in the combined NPC-21 groups (4.1%) versus placebo (13.2%).
- No significant adverse events were observed with NPC-21 administration.
Conclusions:
- Fiztasovimab (NPC-21) demonstrated safety but lacked significant efficacy in preventing CMV infection compared to placebo.
- A trend suggested reduced severe CMV disease with NPC-21.
- Further studies are required to clarify the role of NPC-21 in CMV prevention strategies for kidney transplant patients.
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