A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection (NCT04225923) | Clinical Trial Compass
CompletedPhase 2
A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection
United States87 participantsStarted 2020-06-01
Plain-language 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.
Who can participate
Age range18 Years – 76 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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:
. 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:
✕. Patients with a history of a serious drug allergy to proteins, immunoglobulins, transfusions, or vaccines or any excipient of the NPC-21 formulation.