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

NCT04225923 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2025-06-17

Study results available
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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.

Conditions

  • Cytomegalovirus Disease

Interventions

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

Sponsors & Collaborators

  • Nobelpharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
76 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-11-02
Completion
2023-02-08
FDA Drug
Yes

Countries

  • United States
  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04225923 on ClinicalTrials.gov