Ensayos clínicos

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.
• Female patients of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before Screening) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone in the postmenopausal range at Screening, based on the laboratory’s reference range.
• Female patients of childbearing potential (i.e., not postmenopausal or surgically sterilized) must have a negative urine or serum pregnancy test result at Screening. Participating female patients of childbearing potential must agree to use 1 of the following throughout the duration of the study and for 90 days following the last study drug administration:
  • One highly effective method of contraception and an acceptable barrier method (condom used by male partner plus spermicide);
  • Two highly effective methods of contraception.
• Investigators will select the appropriate methods of contraception in accordance with local regulatory requirements. Highly effective methods of contraception that result in a low failure rate (i.e., < 1% per year) when used consistently and correctly include the following:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable), intrauterine device, or intrauterine hormone-releasing system for at least 12 weeks before Screening;
  • Bilateral tubal occlusion or vasectomized partner at least 26 weeks before Screening.
  • Note: A vasectomized partner is a highly effective method of contraception, provided that the male partner is the sole sexual partner of the study patient who is a female of childbearing potential and that the vasectomized partner has received medical assessment of surgical success;
  • Sexual abstinence.
  • Note: True abstinence, when in line with the preferred and usual lifestyle of the patient, is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study drug treatment. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.
• Male patients must agree to abstain from sperm donation and use condoms with spermicide during sexual intercourse between Screening and at least 90 days after administration of the last dose of study drug. Male patients must ensure nonpregnant female partners of childbearing potential comply with the contraception requirements.

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 (CMV syndrome or tissue-invasive CMV disease) or CMV viremia (polymerase chain reaction [PCR] analysis or antigenemia testing in local laboratory meets the local criteria for 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.
  • Note: In case of hemodialysis patients, body weight is defined immediately after dialysis or dry weight. In case of peritoneal dialysis patients, body weight is defined after removal of dialysate or dry weight.
  • Note: Body weight measured within 7 days prior to pre-Randomization is permitted.
• 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 (e.g., foscarnet, ganciclovir, valganciclovir, letermovir, high dose acyclovir [≥ 500 mg/m^2 intravenously every 8 hours, 10 mg/kg intravenously every 8 hours or 800 mg orally 4 times a day], high dose valacyclovir [1000 mg orally 3 times a day], high dose famciclovir [500 mg orally every 8 hours], 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 (e.g., 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 (e.g., 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 (i.e., 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.

Eligibility last updated 12/28/21. Questions regarding updates should be directed to the study team contact.