This is a Phase II, randomized, double-blind, placebo-controlled study designed to assess the safety and clinical activity of multiple intravenous doses of MCMV5322A/MCMV3068A in cytomegalovirus (CMV)-seronegative recipients of a renal transplant from a CMV-seropositive donor, with use of a preemptive approach for prevention of CMV disease. Participants will be randomized into two treatment groups: active or placebo control; both arms will be followed preemptively. The study has a planned enrollment of approximately 120 participants (60 active and 60 placebo).
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
122
Four doses of MCMV3068A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.
Four doses of MCMV5322A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.
Four doses of placebo matched to MCMV5322A/MCMV3068A administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.
UCLA; Kidney & Pancreas Transplantation
Los Angeles, California, United States
California Inst. of Renal Research
San Diego, California, United States
Univ of CA San Francisco; Kidney Transplant Service
San Francisco, California, United States
University of Colorado Health Sciences Center; Dept of Medicine
Denver, Colorado, United States
Georgetown Uni Hospital; Division of Transplant Surgery
Washington D.C., District of Columbia, United States
Percentage of Participants With Adverse Events
Time frame: Baseline up to Week 24
Percentage of Participants With CMV Viral Load Greater than or Equal to (>=) 150 Copies per Milliliter (Copies/mL) During the First 12 Weeks After Transplantation
Time frame: Baseline up to Week 12
Percentage of Participants With CMV Viral Load >= 150 Copies/mL During the First 24 Weeks After Transplantation
Time frame: Baseline up to Week 24
Time to Detectable CMV Viral Load >=150 Copies/mL
Time frame: Baseline up to Week 24
Viral Load at the First Detection of CMV DNAemia (>=150 Copies/mL), DNAemia is detection of deoxyribonucleic acid (DNA)
Time frame: Baseline up to Week 24
Peak Viral Load on or Following First Detection of CMV DNAemia (>=150 Copies/mL)
Time frame: Baseline up to Week 24
Percentage of Participants who Require Initiation of Pre-emptive Antiviral Therapy During the First 12 Weeks and 24 Weeks After Transplantation
Time frame: Baseline up to Weeks 12 and 24
Time to Initiation of First use of Preemptive Antiviral Therapy
Time frame: Baseline up to Week 24
Duration of First use of Preemptive Antiviral Therapy Initiated During the First 12 and 24 Weeks After Transplantation
Time frame: Baseline up to Weeks 12 and 24
Percentage of Participants With CMV Syndrome or Tissue-Invasive CMV Disease During the First 24 Weeks After Transplantation
Time frame: Baseline up to Week 24
Percentage of Participants With Change in CMV Serostatus
Time frame: Baseline up to Week 24
MCMV5322A Serum Concentrations
Time frame: Up to 24 hours prior to dosing (Day 1) and 1, 4, 24, and 72 hours postdose; predose (0 hours) and 1 hour postdose on Days 8, 29, 57; on Days 43, 58, 64, 71, 78, 85, 113, and 141; at study completion (Day 169)
MCMV3068A Serum Concentrations
Time frame: Up to 24 hours prior to dosing (Day 1) and 1, 4, 24, and 72 hours postdose; predose (0 hours) and 1 hour postdose on Days 8, 29, 57; on Days 43, 58, 64, 71, 78, 85, 113, and 141; at study completion (Day 169)
Percentage of Participants With Anti-therapeutic Antibodies (ATAs) to MCMV5322A and MCMV3068A
Time frame: Predose (0 hours) on Days 1, 29, 57; at Days 85, 113, and 141; and at Study Completion (Day 169)
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Atlanta, Georgia, United States
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Henry Ford Health System; Gastroenterology
Detroit, Michigan, United States
Washington Uni School of Medicine/Barnes Jewish Hospital; Renal
St Louis, Missouri, United States
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