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