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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04225923
Other study ID # NPC-21-2
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 1, 2020
Est. completion date February 8, 2023

Study information

Verified date February 2023
Source Nobelpharma
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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)


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date February 8, 2023
Est. primary completion date November 2, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 76 Years
Eligibility 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: ยท 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
NPC-21 Low dose
NPC-21 will be administered via an approximately 60-minute intravenous infusion
NPC-21 High dose
NPC-21 will be administered via an approximately 60-minute intravenous infusion
NPC-21 Placebo
Placebo will be administered via an approximately 60-minute intravenous infusion

Locations

Country Name City State
Japan Research site_213 Hachioji-shi Tokyo
Japan Marianna University School of Medicine Kawasaki-shi Kanagawa
Japan Research site_206 Kobe Hyogo
Japan Research site_212 Kumamoto-shi Kumamoto
Japan Research site_204 Nagakute Aichi
Japan Research site_201 Nagoya Aichi
Japan Research site_205 Nishinomiya Hyogo
Japan Osaka Metropolitan University Hospital Osaka-shi Osaka
Japan Research site_211 Osaka-shi Osaka
Japan Research site_214 Osaka-shi Osaka
Japan Research site_203 Shimotsuke Tochigi
Japan Research site_208 Suita Osaka
Japan Research site_215 Tomigusuku-shi Okinawa
Japan Research site_202 Toyoake Aichi
United States University of Michigan Ann Arbor Michigan
United States Piedmont Healthcare Atlanta Georgia
United States Augusta University Medical Center Augusta Georgia
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 California Institute of Renal Research La Mesa California
United States University of Wisconsin - Madison Madison Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States University of Nebraska Medical Center Omaha Nebraska
United States Mayo Clinic - Scottsdale Phoenix Arizona
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Nobelpharma

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of CMV disease or CMV viremia Percentage of patients with adjudicated CMV disease or CMV viremia through 16 weeks post-transplant 16 weeks
Secondary Incidence of CMV disease or CMV viremia Percentage of patients with adjudicated CMV disease or CMV viremia. 28 weeks
Secondary Incidence of CMV disease Percentage of patients with adjudicated CMV disease 28 weeks
Secondary Incidence of CMV viremia Percentage of patients with adjudicated CMV viremia. 28 weeks
Secondary Time to detectable CMV disease or CMV viremia 28 weeks
Secondary Time to detectable CMV disease 28 weeks
Secondary Time to detectable CMV viremia 28 weeks
Secondary Amount of CMV DNA 28 weeks
Secondary Incidence and duration of anti-CMV therapy during the Rescue Phase 28 weeks
Secondary Changes in EQ-5D-5L score from Baseline 28 weeks
See also
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Terminated NCT02439957 - A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Phase 3
Active, not recruiting NCT04904614 - Letermovir Use in Heart Transplant Recipients Phase 4
Completed NCT01509404 - Cytogam Administration in Abdominal Organ Transplant Recipients at High Risk for Cytomegalovirus Infection Phase 4
Completed NCT01573039 - Cut Off for the Diagnosis of Cytomegalovirus (CMV) Disease in Serum-positive Kidney Transplant Recipients N/A
Completed NCT00907686 - TT-CMV Observational Birth Cohort Study N/A
Completed NCT04129398 - MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042) Phase 3
Recruiting NCT00828503 - Certican® (Everolimus) Against Cytomegalovirus Disease in Renal Transplant Patients Phase 2