Actively Recruiting
Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)
Led by Camille N. Kotton, MD · Updated on 2025-12-22
80
Participants Needed
2
Research Sites
130 weeks
Total Duration
On this page
Sponsors
C
Camille N. Kotton, MD
Lead Sponsor
U
University of Texas Southwestern Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- High risk pretransplant CMV donor seropositive/recipient seronegative (D+R-) kidney, liver, or simultaneous liver-kidney 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 65 18 years and 65 75 years of age at time of consent
You will not qualify if you...
- 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, poor transplant organ function (e.g. liver function tests > twice the upper limit of normal), on dialysis, on plasmapheresis, relisted for transplant, or at risk of complications as determined by the local investigator
- History of severe reaction to CMV immunoglobulin (e.g. CytoGam�) or other human immunoglobulin preparations
- History of selective immunoglobulin A deficiency
- History of acute myocardial infarction within 12 months, significant arrhythmia, or significant ECG abnormality
- History of active or latent tuberculosis (except completed latent TB treatment) or severe pulmonary disease that may prevent safe study infusions
- History of neurodegenerative disease, dementia, or stroke with substantial residual disability
- Pregnant or nursing women
- Women of childbearing potential not using highly effective contraception during dosing and for 24 weeks after treatment
- Significant history of treatment nonadherence or medical conditions that could confound study results or increase risk
- 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; ALT >5 x upper limit of normal; AST >5 x upper limit of normal; CMV IgG negative in donor or positive in recipient
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
2
University of Texas Southwestern
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
A
Amelia Stocking, BS
CONTACT
C
Camille Kotton, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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