CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 87 enrolled
Drug / intervention
NPC-21 Low dose +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04225923
NCT04225923Phase 2Completed
CompareCT.gov

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

Nobelpharma·interventional·Posted Jan 13, 2020·Updated Jun 17, 2025

In Brief

A Phase 2 clinical trial evaluating NPC-21 Low dose, NPC-21 High dose, and 1 other intervention for Cytomegalovirus Disease. Completed, enrolled 87 participants across 28 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCytomegalovirus Disease
CountriesJapan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJan 13, 2020
Enrollment StartJun 1, 2020
Primary CompletionNov 2, 2022
Study CompletionFeb 8, 2023
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.5 years ago

Interventions

NPC-21 Low dosedrug

NPC-21 will be administered via an approximately 60-minute intravenous infusion on Day 1 and at Week 4, 8, 12

NPC-21 High dosedrug

NPC-21 will be administered via an approximately 60-minute intravenous infusion on Day 1 and at Week 4, 8, 12

NPC-21 Placebodrug

Placebo will be administered via an approximately 60-minute intravenous infusion on Day 1 and at Week 4, 8, 12