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A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT04225923•Nobelpharma

View on ClinicalTrials.gov

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)

Eligibility

Age

18 - 76 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Male or female patients 18 to 75 years of age in the United States or 20 to 75 years of age in Japan at the time of obtaining informed consent.
•2. Patients must be CMV seronegative pre-transplant and scheduled to receive or have received (within 7 days prior to first study drug administration) a first kidney transplant from a CMV seropositive donor.
•3. Patients must be willing and able to give written informed consent for participation in the study.
•4. Patients must be eligible to undergo kidney transplantation from a living or deceased donor, as per institutional standards.
•5. Patients must agree with contraception by using appropriate contraceptive measures.

Exclusion Criteria

•1. Patients who have received a previous solid organ transplantation or hematopoietic stem cell transplantation.
•2. Patients who receive a multi-organ transplant.
•3. Patients who have CMV disease or CMV viremia at Screening.
•4. Patients who have a positive donor-specific antibody within 90 days prior to Randomization confirmed via medical records.
•5. Patients whose body weight is more than 120 kg at Screening.
•6. Patients who have received the following anti-CMV therapy within 7 days prior to Randomization and/or plan to receive the following anti-CMV therapy during the study:
•・ Anti-CMV agents (eg, foscarnet, ganciclovir, valganciclovir, letermovir, high dose acyclovir, high dose valacyclovir, high dose famciclovir, or cidofovir).
•Note: The use of anti-CMV agents per local standard of care during the Rescue Phase of the study is permitted.
•Note: The use of anti-herpes simplex virus and anti-varicella zoster virus prophylaxis for at-risk patients is recommended (as long as the doses are below the one specified above).
•7. Patients who have received the following therapy within 28 days prior to Randomization and/or plan to receive the following anti-CMV therapy during the study:
+15 more criteria

Locations (28)

Mayo Clinic - Scottsdale

Phoenix, Arizona, United States

California Institute of Renal Research

La Mesa, California, United States

Piedmont Healthcare

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

The Christ Hospital

Cincinnati, Ohio, United States

University of Cincinnati College of Medicine

Cincinnati, Ohio, United States

Key Dates

Start Date

June 1, 2020

Primary Completion Date

November 2, 2022

Completion Date

February 8, 2023

Last Updated

June 17, 2025

Enrollment

ACTUAL participants

Conditions

Cytomegalovirus Disease

Interventions

NPC-21 Low dose

DRUG

NPC-21 High dose

DRUG

NPC-21 Placebo

DRUG

MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042)

NCT04129398

Cytomegalovirus InfectionCytomegalovirus Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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