RecruitingPhase 4

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

United States80 participantsStarted 2025-11-27

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 preparati…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants with Late Clinically Significant CMV Disease

Timeframe: Treatment Phase (Day 0) through End of Study (Day 168)

Number of Participants with Adverse Events Related to CMV

Timeframe: Events starting after or increasing in severity following initiation of the Treatment Phase (Day 0) through end of study (Day 168)

Trial details

NCT IDNCT06958796

SponsorCamille N. Kotton, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-30

Contact for this trial

Amelia Stocking, BS

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

View on ClinicalTrials.gov More Cytomegalovirus trials