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

NCT ID: NCT04225923

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2023-02-08

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

NPC-21 Low dose

NPC-21 (6mg/kg) will be administered

Group Type: EXPERIMENTAL

NPC-21 Low dose

Intervention Type: DRUG

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

NPC-21 High dose

NPC-21 (12mg/kg) will be administered

Group Type: EXPERIMENTAL

NPC-21 High dose

Intervention Type: DRUG

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

NPC-21 Placebo

Placebo (normal saline) will be administered

Group Type: PLACEBO_COMPARATOR

NPC-21 Placebo

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

NPC-21 Placebo

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

Intervention Type: DRUG

Eligibility Criteria

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:

• CMV hyperimmune globulin (eg, CytoGam).
• Intravenous immunoglobulin.
• Plasmapheresis (receipt prior to first study drug administration is acceptable).

8. Patients with a history of a serious drug allergy to proteins, immunoglobulins, transfusions, or vaccines or any excipient of the NPC-21 formulation.

9. Patients with severe hepatic insufficiency at Screening (eg, Child-Pugh Class C).

10. Patients with active and untreated hepatitis B virus or hepatitis C virus, as documented as part of the pre-transplant screening.

11. Patients with known human immunodeficiency virus infection, based on medical records serology.

12. Patients with any uncontrolled infection at Randomization or a history of serious and uncontrolled infection within 6 months prior to Randomization.

13. Patients who are pregnant or lactating.

14. Patients with a history of malignancy within 5 years prior to Randomization other than curatively treated in situ cervical carcinoma, cutaneous basal cell carcinoma, or cutaneous squamous cell carcinoma.

15. Patients with a history of alcohol or drug abuse or dependence within 1 year prior to Randomization that, in the opinion of the Investigator, would preclude study participation.

16. Patients who have previously participated in this study or any other study involving NPC-21.

17. Patients who have previously participated or are currently participating in any study involving the administration of a CMV vaccine or another CMV investigational agent.

18. Patients who have participated in another interventional clinical study and received another investigational product (ie, not approved by the Food and Drug Administration in the United States or the Ministry of Health, Labour and Welfare in Japan) within 90 days before Randomization.

19. Patients who are unable or unwilling, in the opinion of the Investigator, to comply with the protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 76 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nobelpharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Cleveland Clinic

Cleveland, Ohio, United States

Renal Disease Research Institute

Dallas, Texas, United States

University of Texas Southwestern

Dallas, Texas, United States

University of Wisconsin - Madison

Madison, Wisconsin, United States

Research site_204

Nagakute, Aichi-ken, Japan

Research site_201

Nagoya, Aichi-ken, Japan

Research site_202

Toyoake, Aichi-ken, Japan

Research site_206

Kobe, Hyōgo, Japan

Research site_205

Nishinomiya, Hyōgo, Japan

Research site_217

Kawasaki-shi, Kanagawa, Japan

Research site_212

Kumamoto, Kumamoto, Japan

Research site_215

Tomigusuku-shi, Okinawa, Japan

Research site_211

Osaka, Osaka, Japan

Research site_214

Osaka, Osaka, Japan

Research site_216

Osaka, Osaka, Japan

Research site_208

Suita, Osaka, Japan

Research site_203

Shimotsuke, Tochigi, Japan

Research site_213

Hachioji-shi, Tokyo, Japan

Countries

United States; Japan

References

Ichimaru N, Natori Y, Alloway RR, Wojciechowski D, Castillo Almeida NE, Futamura K, Watanabe T, Nakagawa K, Egawa H; LionHeart21 Study Group. Phase 2, Randomized, Double-blind, Placebo-controlled Study of Fiztasovimab (NPC-21) for Kidney Transplant Recipients at High Risk of Cytomegalovirus Infection (LionHeart21). Transplantation. 2025 Jun 1;109(6):985-993. doi: 10.1097/TP.0000000000005260. Epub 2025 May 18.

Reference Type: RESULT

PMID: 40072882 (View on PubMed)

Vernooij RW, Michael M, Ladhani M, Webster AC, Strippoli GF, Craig JC, Hodson EM. Antiviral medications for preventing cytomegalovirus disease in solid organ transplant recipients. Cochrane Database Syst Rev. 2024 May 3;5(5):CD003774. doi: 10.1002/14651858.CD003774.pub5.

Reference Type: DERIVED

PMID: 38700045 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

NPC-21-2

Identifier Type: -

Identifier Source: org_study_id