Clinical Trial: A Study of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-Risk Kidney Allograft Recipients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase II Randomized, Double-blind, Placebo-controlled Trial of MCMV5322A/MCMV3068A for the Prevention of Cytomegalovirus Disease in High-risk Kidney Allograft Recipients
Brief Summary: 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).
Detailed Summary:
Sponsor: Genentech, Inc.
Current Primary Outcome:
- 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 ]
Original Primary Outcome: Safety: Incidence of adverse events [ Time Frame: 24 weeks ]
Current Secondary Outcome:
- 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) ]
Original Secondary Outcome:
- Cytomegalovirus (CMV) load as assessed by the central laboratory [ Time Frame: 12 weeks ]
- Cytomegalovirus load as assessed by the central laboratory [ Time Frame: 24 weeks ]
- Time to detectable of CMV viremia [ Time Frame: 24 weeks ]
- Viral load at first detection of CMV viremia [ Time Frame: 24 weeks ]
- Peak viral load on or following first detection of CMV viremia [ Time Frame: 24 weeks ]
- Initiation of preemptive antiviral therapy during the first 12 weeks after transplantation [ Time Frame: 12 weeks ]
- Initiation of preemptive antiviral therapy during the first 24 weeks after transplantation [ Time Frame: 24 weeks ]
- Time to Initiation of First use of Preemptive Antiviral Therapy [ Time Frame: 24 weeks ]
- Duration of first use of preemptive antiviral therapy initiated during the first 12 weeks after transplantation [ Time Frame: 12 weeks ]
- Duration of all use of preemptive antiviral therapy initiated during the first 24 weeks after transplantation [ Time Frame: 24 weeks ]
- CMV disease (CMV syndrome or tissue-invasive disease) during the first 24 weeks after transplantation [ Time Frame: 24 weeks ]
- Change in CMV serostatus as assessed by the central laboratory [ Time Frame: From baseline to 24 weeks ]
Information By: Genentech, Inc.
Dates:
Date Received: December 17, 2012
Date Started: December 14, 2012
Date Completion:
Last Updated: March 7, 2017
Last Verified: March 2017