Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Camille N. Kotton, MD
Study ID
NCT06958796
Phase
PHASE4
Status
Recruiting
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Conditions

  • Cytomegalovirus
  • Kidney Transplant; Complications
  • Liver Transplant Complications
  • Organ Transplant
  • Simultaneous Liver-Kidney Transplantation; Complications

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months — DRUG
    The interventional arm will receive Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months as (150 mg/kg) for 3 consecutive months (Days 0, 28 and 56 +/- 3 days). The non-interventional arm will not receive any intervention.

Study Details

This study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help transplant recipients with a high risk for developing late CMV disease after a liver and/or kidney transplant.

Key Dates

Start date
Nov 27, 2025
Status verified
Dec 2025
Primary completion
Dec 30, 2027
Completion
May 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Arm A: CytoGam®
    Participants assigned to receive CytoGam® will receive an infusion once a month for three months at their study site. The infusion will be completed over an average of about 4 hours; these three visits will last about 5 hours. During these study staff will review concomitant medications and adverse events. Participants will be asked to have blood taken at infusion visits and 2 weeks after an infusion visit to check the level of CMV DNA in their blood.
  • No Intervention: Arm B: Standard of Care
    Participants assigned to Arm B, will be asked to complete a telephone call visit once a month. During these visits, a member of study staff will review concomitant medications and adverse events. Participants will be asked to have their blood taken every two weeks to check the level of CMV DNA.

Primary Outcome Measure

Number of Participants with Late Clinically Significant CMV Disease [ Time Frame: Treatment Phase (Day 0) through End of Study (Day 168) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
MGH Abdominal Transplant Unit
[email protected]
617-643-4087
Camille Kotton, MD (PRINCIPAL_INVESTIGATOR)
University of Texas SouthwesternDallasTexas75390
Jarrett Hubbard, BA
[email protected]
214-648-3111
David Wojciechowski, DO
[email protected]
(214) 648-3111
David Wojciechowski, DO (PRINCIPAL_INVESTIGATOR)

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