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

Completed · Phase 2 · Has a placebo group

Conditions studied: Cytomegalovirus Disease

In brief

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.

Key facts

Study ID

NCT04225923

Run by

Nobelpharma

People needed

87

Starts

2020-06-01

Expected to finish

2023-02-08

Last updated by the study team

2025-06-17

Who can join

Age: 18 and older, up to 76. Sex: any. Healthy volunteers: not accepted.

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).
• 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.

Where it is running

• Mayo Clinic - Scottsdale — Phoenix, Arizona, United States
• California Institute of Renal Research — La Mesa, California, United States
• Piedmont Healthcare — Atlanta, Georgia, United States
• Augusta University Medical Center — Augusta, Georgia, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, 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
• University of Wisconsin - Madison — Madison, Wisconsin, United States
• Research site_204 — Nagakute, Aichi-ken, Japan
• Research site_201 — Nagoya, Aichi-ken, Japan
• Research site_202 — Toyoake, Aichi-ken, Japan
• Research site_206 — Kobe, Hyōgo, Japan
• Research site_205 — Nishinomiya, Hyōgo, Japan
• Research site_217 — Kawasaki-shi, Kanagawa, Japan
• Research site_212 — Kumamoto, Kumamoto, Japan
• Research site_215 — Tomigusuku-shi, Okinawa, Japan
• Research site_211 — Osaka, Osaka, Japan
• Research site_214 — Osaka, Osaka, Japan
• Research site_216 — Osaka, Osaka, Japan

Full record on ClinicalTrials.gov

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