Cytomegalovirus DiseasePhase 2NCT04225923
A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection
A Phase 2 study testing NPC-21 Low dose and NPC-21 High dose in people with Cytomegalovirus Disease, run by Nobelpharma at 28 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Cytomegalovirus Disease
- What is being tested?
- NPC-21 Low dose and NPC-21 High dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 28 sitesin 2 countries
- Study dates
- 1 Jun 2020to 8 Feb 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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:
Show all 25Show fewer
- ・ 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).
- Patients with active and untreated hepatitis B virus or hepatitis C virus, as documented as part of the pre-transplant screening.
- Patients with known human immunodeficiency virus infection, based on medical records serology.
- Patients with any uncontrolled infection at Randomization or a history of serious and uncontrolled infection within 6 months prior to Randomization.
- Patients who are pregnant or lactating.
- 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.
- 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.
- Patients who have previously participated in this study or any other study involving NPC-21.
- Patients who have previously participated or are currently participating in any study involving the administration of a CMV vaccine or another CMV investigational agent.
- 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.
- Patients who are unable or unwilling, in the opinion of the Investigator, to comply with the protocol.
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States14 sites
University of Michigan
Ann Arbor, Michigan, 48084
Piedmont Healthcare
Atlanta, Georgia, 30309
Augusta University Medical Center
Augusta, Georgia, 30912
The Christ Hospital
Cincinnati, Ohio, 45219
University of Cincinnati College of Medicine
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Renal Disease Research Institute
Dallas, Texas, 75235
University of Texas Southwestern
Dallas, Texas, 75390
California Institute of Renal Research
La Mesa, California, 91942
University of Wisconsin - Madison
Madison, Wisconsin, 53792
University of Minnesota
Minneapolis, Minnesota, 55455
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Mayo Clinic - Scottsdale
Phoenix, Arizona, 85054
Washington University School of Medicine
St Louis, Missouri, 63110
Japan14 sites
Research site_213
Hachioji-shi, Tokyo
Research site_217
Kawasaki-shi, Kanagawa
Research site_206
Kobe, Hyōgo
Research site_212
Kumamoto, Kumamoto
Research site_204
Nagakute, Aichi-ken
Research site_201
Nagoya, Aichi-ken
Research site_205
Nishinomiya, Hyōgo
Research site_211
Osaka, Osaka
Research site_214
Osaka, Osaka
Research site_216
Osaka, Osaka
Research site_203
Shimotsuke, Tochigi
Research site_208
Suita, Osaka
Research site_215
Tomigusuku-shi, Okinawa
Research site_202
Toyoake, Aichi-ken
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of NPC-21 for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection
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.
Read the 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
- Being tested
- NPC-21 Low dose, NPC-21 High dose, NPC-21 Placebo
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| NPC-21 Low dose | Experimental | NPC-21 (6mg/kg) will be administered Receives: Drug: NPC-21 Low dose |
| NPC-21 High dose | Experimental | NPC-21 (12mg/kg) will be administered Receives: Drug: NPC-21 High dose |
| NPC-21 Placebo | Placebo comparator | Placebo (normal saline) will be administered Receives: Drug: NPC-21 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (6)
Incidence of CMV Disease or CMV Viremia
The proportion of patients with CMV disease or CMV viremia. 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.
Measured: 28 weeks
Incidence of CMV Disease
The proportion of patients with CMV disease
Measured: 28 weeks
Incidence of CMV Viremia
The proportion of patients with CMV viremia.
Measured: 28 weeks
Time to Detectable CMV Disease or CMV Viremia
The count and proportion of patients experiencing event and censored will be summarized by treatment group.
Measured: 28 weeks
Time to Detectable CMV Disease
The count and proportion of patients experiencing event and censored will be summarized by treatment group.
Measured: 28 weeks
Time to Detectable CMV Viremia
The count and proportion of patients experiencing event and censored will be summarized by treatment group.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Jun 2020
- Primary completion2 Nov 2022
- Study completion8 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cytomegalovirus DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nobelpharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225923
- Sponsor's protocol ID
- NPC-21-2
- Status last verified
- Jun 2025
- First submitted
- 9 Jan 2020
- Last updated
- 17 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40072882Vernooij 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.
PubMed 38700045
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of NPC-21 for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection
- ClinicalTrials.gov ID
- NCT04225923
- Acronym / sponsor ID
- NPC-21-2
- Conditions
- Cytomegalovirus Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- NobelpharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 8 Feb 2023 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Posted 28 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NPC-21 Low dose | Experimental | Drug: NPC-21 Low doseNPC-21 (6mg/kg) will be administered |
| NPC-21 High dose | Experimental | Drug: NPC-21 High doseNPC-21 (12mg/kg) will be administered |
| NPC-21 Placebo | Placebo comparator | Drug: NPC-21 PlaceboPlacebo (normal saline) will be administered |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NPC-21 Low doseNPC-21 will be administered via an approximately 60-minute intravenous infusion on Day 1 and at Week 4, 8, 12 | Drug | NPC-21 Low dose |
| NPC-21 High doseNPC-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 PlaceboPlacebo will be administered via an approximately 60-minute intravenous infusion on Day 1 and at Week 4, 8, 12 | Drug | NPC-21 Placebo |
Primary outcome
Incidence of CMV Disease or CMV Viremia
Time frame: 16 weeks
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.
6 secondary outcomes
Incidence of CMV Disease or CMV Viremia
Time frame: 28 weeks
Incidence of CMV Disease
Time frame: 28 weeks
Incidence of CMV Viremia
Time frame: 28 weeks
Time to Detectable CMV Disease or CMV Viremia
Time frame: 28 weeks
Time to Detectable CMV Disease
Time frame: 28 weeks
Time to Detectable CMV Viremia
Time frame: 28 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40072882Ichimaru 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.
- Derived from this study: PubMed 38700045Vernooij 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NPC-21 Low dose and NPC-21 High dose in people with Cytomegalovirus Disease, run by Nobelpharma at 28 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CMV Disease or CMV Viremia (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04225923, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.