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.
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
87
NPC-21 will be administered via an approximately 60-minute intravenous infusion on Day 1 and at Week 4, 8, 12
NPC-21 will be administered via an approximately 60-minute intravenous infusion on Day 1 and at Week 4, 8, 12
Placebo will be administered via an approximately 60-minute intravenous infusion on Day 1 and at Week 4, 8, 12
Mayo Clinic - Scottsdale
Phoenix, Arizona, United States
Incidence of CMV Disease or CMV Viremia
The proportion of patients with CMV disease (CMV syndrome or tissue-invasive CMV disease) or CMV viremia (defined as the detection of 250 IU/mL in plasma measured by PCR analysis in central laboratory or meets the local criteria for CMV viremia measured by PCR analysis or antigenemia testing) per total patients through 16 weeks from first study drug administration. The non-responders include all patients who develop CMV disease or CMV viremia and patients who discontinue from the study in the absence of CMV disease or CMV viremia.
Time frame: 16 weeks
Incidence of CMV Disease or CMV Viremia
The proportion of patients with CMV disease or CMV viremia. The non-responders include all patients who develop CMV disease or CMV viremia and patients who discontinue from the study in the absence of CMV disease or CMV viremia.
Time frame: 28 weeks
Incidence of CMV Disease
The proportion of patients with CMV disease
Time frame: 28 weeks
Incidence of CMV Viremia
The proportion of patients with CMV viremia.
Time frame: 28 weeks
Time to Detectable CMV Disease or CMV Viremia
The count and proportion of patients experiencing event and censored will be summarized by treatment group.
Time frame: 28 weeks
Time to Detectable CMV Disease
The count and proportion of patients experiencing event and censored will be summarized by treatment group.
Time frame: 28 weeks
Time to Detectable CMV Viremia
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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
...and 18 more locations
The count and proportion of patients experiencing event and censored will be summarized by treatment group.
Time frame: 28 weeks