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Study of CytoGam® for CMV Prevention After Transplant

This study, called "Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)", is looking at whether a medicine called Cytomegalovirus Immune Globulin Intravenous (Human) (also known as CytoGam®) can help prevent a serious infection called Cytomegalovirus (CMV) in people who have had a kidney, liver, or simultaneous liver-kidney transplant. CMV is a common virus that can cause problems, especially in people with weakened immune systems, like transplant recipients. You might be able to join if you are between 18 and 75 years old, have had one of these transplants, and are at high risk for CMV because your donor had CMV but you didn't (D+R-). The study will measure how many participants get late CMV disease and how many have side effects related to CMV. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 80 participants. Some participants will receive the study drug, while others will not.
What's involved
If you are in the interventional arm, you would receive Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months. You would also need to do routine blood testing, which is standard care for transplant recipients.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the start of treatment (Day 0) through the end of the study (Day 168).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06958796

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

Recruiting
PHASE4Ages 18–75InterventionalPrevention
Camille N. Kotton, MD
~80 participants
Updated 2025-12-22 on ClinicalTrials.gov
What's tested:Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants with Late Clinically Significant CMV Disease
Measured over Treatment Phase (Day 0) through End of Study (Day 168)
+1 more outcome measured

Conditions

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

Explore related trials

CytomegalovirusKidney TransplantationLiver TransplantationSimultaneous Liver-Kidney Transplantation

Where it's being run

2 sites across 2 states
Massachusetts1
Texas1

Study leadership

  • Camille Kotton, MD, FIDSA, FAST · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
  • David Wojciechowski, DO · PRINCIPAL_INVESTIGATOR · University of Texas Southwestern Medical Center

Who to contact

Amelia Stocking, BS
[email protected]
617-643-4087
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Number of Participants with Late Clinically Significant CMV DiseaseTreatment Phase (Day 0) through End of Study (Day 168)

    Comparison between treatment groups of number of participants with a blood CMV viral load \>1000 IU/ml at any point during the treatment phase through end of study

  • Number of Participants with Adverse Events Related to CMVEvents starting after or increasing in severity following initiation of the Treatment Phase (Day 0) through end of study (Day 168)

    Congregate data of all Adverse Events (including Serious Adverse Events) will be compared between treatment arms. The number and percent of CMV related AEs will be summarized by: Organ system impacted Relationship to CMV Severity Deaths Those leading to: 1. Initiation of CMV treatment 2. Hospitalization due to CMV