ionHeart21
- Conditions
- Cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seroposit
- Registration Number
- JPRN-jRCT2041200019
- Lead Sponsor
- Ichimaru Naotsugu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 108
1.Male or female patients 18 to 75 years of age in the United States or 20 to 75 years of age in Japan.
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.
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with adjudicated CMV disease or CMV viremia through 16 weeks post-transplant
- Secondary Outcome Measures
Name Time Method - Incidence of CMV disease or CMV viremia by Week 28 <br>- Incidence of CMV disease<br>- Incidence of CMV viremia<br>- Time to detectable CMV disease or CMV viremia<br>- Time to detectable CMV disease<br>- Time to detectable CMV viremia<br>- Amount of CMV DNA by PCR analyzed by the central laboratory<br>- Incidence and duration of anti-CMV therapy during the Rescue Phase<br>- Changes in EQ-5D-5L score from Baseline to Weeks 16 and 28