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

NCT04225923 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: NPC-21-2
• Study Type: interventional
• Target: 87
• Locations: 2 countries
• Sites: 28

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.

Conditions

Cytomegalovirus Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of CMV Disease or CMV Viremia

  The proportion of patients with CMV disease (CMV syndrome or tissue-invasive CMV disease) or CMV viremia (defined as the detection of 250 IU/mL in plasma measured by PCR analysis in central laboratory or meets the local criteria for CMV viremia measured by PCR analysis or antigenemia testing) per total patients through 16 weeks from first study drug administration. The non-responders include all patients who develop CMV disease or CMV viremia and patients who discontinue from the study in the absence of CMV disease or CMV viremia.

  16 weeks

Secondary Outcomes (6)

• Incidence of CMV Disease or CMV Viremia

  28 weeks

• Incidence of CMV Disease

  28 weeks

• Incidence of CMV Viremia

  28 weeks

• Time to Detectable CMV Disease or CMV Viremia

  28 weeks

• Time to Detectable CMV Disease

  28 weeks

Study Arms (3)

NPC-21 Low dose

EXPERIMENTAL

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

Drug: NPC-21 Low dose

NPC-21 High dose

EXPERIMENTAL

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

Drug: NPC-21 High dose

NPC-21 Placebo

PLACEBO COMPARATOR

Placebo (normal saline) will be administered

Drug: NPC-21 Placebo

Interventions

NPC-21 Low dose DRUG

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

NPC-21 Low dose

NPC-21 High dose 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 Placebo DRUG

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

NPC-21 Placebo

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Patients must be willing and able to give written informed consent for participation in the study.
• Patients must be eligible to undergo kidney transplantation from a living or deceased donor, as per institutional standards.
• Patients must agree with contraception by using appropriate contraceptive measures.

You may not qualify if:

• Patients who have received a previous solid organ transplantation or hematopoietic stem cell transplantation.
• Patients who receive a multi-organ transplant.
• Patients who have CMV disease or CMV viremia at Screening.
• Patients who have a positive donor-specific antibody within 90 days prior to Randomization confirmed via medical records.
• Patients whose body weight is more than 120 kg at Screening.
• 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).
• 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).
• Patients with a history of a serious drug allergy to proteins, immunoglobulins, transfusions, or vaccines or any excipient of the NPC-21 formulation.
• Patients with severe hepatic insufficiency at Screening (eg, Child-Pugh Class C).

Sponsors & Collaborators

• Nobelpharma: lead

Study Sites (28)

Mayo Clinic - Scottsdale

Phoenix, Arizona, 85054, United States

Location

California Institute of Renal Research

La Mesa, California, 91942, United States

Location

Piedmont Healthcare

Atlanta, Georgia, 30309, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

University of Michigan

Ann Arbor, Michigan, 48084, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

University of Cincinnati College of Medicine

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Renal Disease Research Institute

Dallas, Texas, 75235, United States

Location

University of Texas Southwestern

Dallas, Texas, 75390, United States

Location

University of Wisconsin - Madison

Madison, Wisconsin, 53792, United States

Location

Research site_204

Nagakute, Aichi-ken, Japan

Location

Research site_201

Nagoya, Aichi-ken, Japan

Location

Research site_202

Toyoake, Aichi-ken, Japan

Location

Research site_206

Kobe, Hyōgo, Japan

Location

Research site_205

Nishinomiya, Hyōgo, Japan

Location

Research site_217

Kawasaki-shi, Kanagawa, Japan

Location

Research site_212

Kumamoto, Kumamoto, Japan

Location

Research site_215

Tomigusuku-shi, Okinawa, Japan

Location

Research site_211

Osaka, Osaka, Japan

Location

Research site_214

Osaka, Osaka, Japan

Location

Research site_216

Osaka, Osaka, Japan

Location

Research site_208

Suita, Osaka, Japan

Location

Research site_203

Shimotsuke, Tochigi, Japan

Location

Research site_213

Hachioji-shi, Tokyo, Japan

Location

Related Publications (2)

• 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.

  PMID: 40072882 RESULT

• 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.

  PMID: 38700045 DERIVED

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Limitations and Caveats

Patients who developed CMV disease or CMV viremia received rescue therapy and administration of NPC-21 or Placebo was discontinued. Patients who completed rescue therapy withdrew early from the study.

Results Point of Contact

• Title: Research & Development Divion
• Organization: Nobelpharma Co. Ltd.

watanabe.tatsuya@nobelpharma.co.jp

81-3-6670-3800

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 13, 2020
• Study Start: June 1, 2020
• Primary Completion: November 2, 2022
• Study Completion: February 8, 2023
• Last Updated: June 17, 2025
• Results First Posted: June 28, 2024

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

JP (14); US (14)