NCT04225923

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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of NPC-21 for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Nobelpharma · Industry
• Sex: All
• Age: 18 Years – 76 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a Phase 2, randomized, double-blind, placebo-controlled study of NPC-21 for kidney transplant recipients at high risk of CMV infection in the United States and Japan. Approximately 108 eligible patients will be randomized prior to first study drug administration to receive low-dose NPC 21, high-dose NPC-21, or placebo. Randomization will be stratified by region (United States or Japan)

Conditions

• Cytomegalovirus Disease

Interventions

Type	Name	Description
DRUG	NPC-21 Low dose	NPC-21 will be administered via an approximately 60-minute intravenous infusion on Day 1 and at Week 4, 8, 12
DRUG	NPC-21 High dose	NPC-21 will be administered via an approximately 60-minute intravenous infusion on Day 1 and at Week 4, 8, 12
DRUG	NPC-21 Placebo	Placebo will be administered via an approximately 60-minute intravenous infusion on Day 1 and at Week 4, 8, 12

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-11-02
• Completion: 2023-02-08
• First posted: 2020-01-13
• Last updated: 2025-06-17
• Results posted: 2024-06-28

Locations

28 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study