Recruiting

CytoGam®

Sponsor:

Camille N. Kotton, MD

Code:

NCT06958796

Conditions

Cytomegalovirus

Organ Transplant

Kidney Transplant; Complications

Liver Transplant Complications

Simultaneous Liver-Kidney Transplantation; Complications

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months

Study Details

Brief summary:

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.

Conditions

Cytomegalovirus

Organ Transplant

Kidney Transplant; Complications

Liver Transplant Complications

Simultaneous Liver-Kidney Transplantation; Complications

Study ID

NCT06958796

Start date

Nov 27, 2025

Status verified date

Dec, 2025

Completion date

May 31, 2028

Anticipated

Primary completion date

Dec 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • High risk pretransplant CMV donor seropositive/recipient seronegative (D+R-) kidney, liver, or simultaneous liver-kidney (SLK) transplant recipients
  • Able to do routine blood testing (normal care for transplant recipients)
  • Written informed consent obtained from the subject before any trial-related procedures
  • Be ≥18 years and ≤75 years of age at time of consent

Exclusion Criteria

  • Any pre-transplant CMV serologic combinations besides CMV D+/R-
  • Multi organ transplants (other than simultaneous liver-kidney transplant (SLK) recipients) or prior history of bone marrow or stem cell transplant
  • Lung, heart, small bowel, pancreas, or other non-kidney or non-liver transplant recipients
  • Transplant recipients treated for rejection within three months before the end of valganciclovir prophylaxis
  • Participation in another interventional clinical trial at time of consent or within 30 days prior to study consent
  • Transplant recipients with eGFR <30 ml/min/1.73m2 (as they theoretically could be at higher risk for renal impairment with CMV immunoglobulin), poor transplant organ function (i.e. LFTs > twice the upper limit of normal in liver recipients), or who are on dialysis, or plasmapheresis, or who are relisted for transplant, or who might otherwise at risk of complications at the discretion of the local site investigator.
  • Those with a history of severe reaction to CMV immunoglobulin (e.g. CytoGam® or similar) or other human immunoglobulin preparations
  • Individuals with a history of selective immunoglobulin A deficiency will be excluded, as they may produce antibodies against immunoglobulin A, leading to potential anaphylactic reactions upon receiving blood products containing immunoglobulin A, such as CMV immunoglobulin (e.g. CytoGam® or similar)
  • Any history of acute myocardial infarction (within 12 months of screening), clinically significant arrythmia, or clinically significant ECG abnormality in the opinion of the investigator at time of screening
  • History of active or latent tuberculosis (except those who have completed a documented regimen for latent TB treatment) or severe pulmonary disease \[e.g., severe pulmonary hypertension (WHO class IV)\] that in the opinion of the investigator that may preclude their ability to safely tolerate study infusions
  • Any history of neurodegenerative disease, including dementia, or stroke with substantial residual disability (modified Rankin score ≥ 3)
  • Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test.
  • Women of childbearing potential unless using a highly effective method of contraception during dosing and for 24 weeks after study treatment. Medically acceptable birth control (contraceptives) includes but are not limited to: surgical sterilization (such as hysterectomy or "tubes tied"), approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Depo-Lupron, lmplanon), barrier methods (such as condom or diaphragm), an intrauterine device (IUD), abstinence from sex.
  • Any significant history of any treatment nonadherence or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
  • Subjects who have any of the following laboratory values: eGFR <30 ml/min/1.73m2 ; Hemoglobin <8.0 g/dL; Platelets <50,000 cells/uL; Absolute neutrophil count <1,000 cells/uL; Total bilirubin >2.5 x upper limit of normal; Alanine aminotransferase (ALT) >5 x upper limit of normal; Aspartate aminotransferase (AST)\] >5 x upper limit of normal; CMV IgG negative in donor or positive in recipient

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months

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.

Primary outcome measure

  • Number of Participants with Late Clinically Significant CMV Disease [ Time Frame: Treatment Phase (Day 0) through End of Study (Day 168) ]
  • Number of Participants with Adverse Events Related to CMV [ Time Frame: Events starting after or increasing in severity following initiation of the Treatment Phase (Day 0) through end of study (Day 168) ]

Central Contacts and Locations

Central contacts

Amelia Stocking, BS

617-643-4087astocking@mgh.harvard.edu

Camille Kotton, MD

6177240084ckotton@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

MGH Abdominal Transplant Unit

617-643-4087TransplantResearchUnit@MassgeneralBrigham.org

Principal Investigator:

Camille Kotton, MD

University of Texas Southwestern

Recruiting

Dallas, Texas, United States, 75390

Contacts

Jarrett Hubbard, BA

214-648-3111Jarrett.Hubbard@UTSouthwestern.edu

David Wojciechowski, DO

(214) 648-3111David.Wojciechowski@UTSouthwestern.edu

Principal Investigator:

David Wojciechowski, DO

More Information

Sponsor

Camille N. Kotton, MD

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Keywords

  • cytomegalovirus
  • valganciclovir
  • organ transplant
  • immunoglobulin
  • CMV
  • High Risk CMV

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Camille N. Kotton, MD on 2025-12-22.