The Third International Consensus Guidelines on the Management of Cytomegalovirus in Solid-organ Transplantation.
Camille N Kotton, Deepali Kumar, Angela M Caliendo...
https://pubmed.ncbi.nlm.nih.gov/29596116Actively Recruiting
Phase 4
Age: 18Years - 75Years
All Genders
ID06958796
Exploratory Use of CMV Immunoglobulin in High Risk (D+R-) Transplant Recipients at the End of Antiviral Prophylaxis to Decrease the Risk of Late CMV Infection
Led by Camille N. Kotton, MD · Updated on 2025-12-22
80
Participants Needed
2
Research Sites
21 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
Researchers are studying whether giving CytoGam (a type of immunoglobulin) after completing standard antiviral prevention can help people at high risk of developing late cytomegalovirus (CMV) disease following liver, kidney, or simultaneous liver-kidney transplants. CMV is a common virus that can be inactive in healthy individuals but may reactivate and cause serious disease in transplant recipients with weakened immune systems due to anti-rejection medications. Participants will be randomly assigned to one of two groups: one group receives CytoGam infusions once a month for three months, while the other group receives standard care without additional intervention. Each CytoGam infusion takes about four hours, and the study includes blood tests to monitor CMV DNA levels. The study aims to find out if CytoGam can reduce the risk of late CMV disease after the usual antiviral treatment ends. During the study, participants will have scheduled visits for infusions or telephone calls, with regular blood tests to check for CMV activity. Researchers will monitor for late CMV disease and any adverse events related to CMV from the start of treatment through 168 days. The study also measures CMV DNA levels over time to evaluate treatment effects and safety, with close monitoring of participants' health throughout the study period.
CONDITIONS
Brief Title
Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- 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 as part of normal transplant care
- Signed informed consent before any trial procedures
- Age between 18 and 75 years at time of consent
You will not qualify if you...
- Any CMV serologic combination other than donor positive/recipient negative (D+R-)
- Multi-organ transplants except simultaneous liver-kidney transplant
- Prior bone marrow or stem cell transplant
- Lung, heart, small bowel, pancreas, or other non-kidney/liver transplants
- Treatment for transplant rejection within 3 months before end of valganciclovir prophylaxis
- Participation in another interventional trial within 30 days prior to consent
- eGFR less than 30 ml/min/1.73m2, poor organ function, on dialysis, plasmapheresis, or relisted for transplant
- History of severe reaction to CMV immunoglobulin or similar products
- History of selective immunoglobulin A deficiency
- Recent acute myocardial infarction, significant arrhythmia, or ECG abnormalities
- History of active or latent tuberculosis or severe pulmonary disease that may prevent safe study infusion
- History of neurodegenerative disease, dementia, or stroke with major disability
- Pregnant or nursing women
- Women of childbearing potential not using highly effective contraception during dosing and 24 weeks after
- History of treatment nonadherence or medical conditions that may confound study results or increase risk
- Laboratory values outside specified limits including low hemoglobin, platelets, neutrophils, or abnormal liver tests
- Donor CMV IgG negative or recipient CMV IgG positive
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months
Participants receive either monthly CytoGam® infusions for three months or standard care without infusions after completing antiviral prophylaxis. Blood tests are done during and between visits to monitor CMV levels and health status.
3 infusion visits lasting about 5 hours each for CytoGam® recipients; monthly telephone visits for standard care participants; blood tests every 2 weeks
Follow-up
Duration - Approximately 3 months
Participants are monitored for late CMV infection and adverse events through regular blood testing and telephone check-ins after completing the treatment phase.
Blood tests every 1 to 2 weeks; periodic telephone visits
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
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Research Team
A
Amelia Stocking, BS
C
Camille Kotton, MD
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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Published Research Related To This Trial
Cytomegalovirus in solid organ transplant recipients-Guidelines of the American Society of Transplantation Infectious Diseases Community of Practice.
Raymund R Razonable, Atul Humar
https://pubmed.ncbi.nlm.nih.gov/30817026Correlation of Cytomegalovirus (CMV) Disease Severity and Mortality With CMV Viral Burden in CMV-Seropositive Donor and CMV-Seronegative Solid Organ Transplant Recipients.
Jacqueline M McBride, Daniel Sheinson, Jenny Jiang...
https://pubmed.ncbi.nlm.nih.gov/30775403Consensus Definitions of Cytomegalovirus (CMV) Infection and Disease in Transplant Patients Including Resistant and Refractory CMV for Use in Clinical Trials: 2024 Update From the Transplant Associated Virus Infections Forum.
Per Ljungman, Roy F Chemaly, Fareed Khawaya...
https://pubmed.ncbi.nlm.nih.gov/39041385