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

Cytomegalovirus Disease Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of NPC-21 for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04225923
• Other study ID #: NPC-21-2
• Status: Completed
• Phase: Phase 2
• 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
• 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:

· 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.

Related Conditions & MeSH terms

• Cytomegalovirus Disease
• Cytomegalovirus Infections

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