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Led by Camille N. Kotton, MD · Updated on 2025-12-22
80
Participants Needed
2
Research Sites
21 weeks
Total Duration
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
Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)
A
Amelia Stocking, BS
C
Camille Kotton, MD
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Camille N. Kotton, MD
Lead Sponsor
University of Texas Southwestern Medical Center
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | CytoGam® monthly after transplant | Standard Care (no immunoglobulin) | Guideline-recommended antiviral prophylaxis |
|---|---|---|---|
| What it is | Intravenous CytoGam® (cytomegalovirus immune globulin) given monthly for three months after transplant, targeting high-risk (D+R-) kidney, liver, or liver-kidney recipients. | Standard care after transplant without CytoGam® or immunoglobulin. Trial protocol does not add specific antiviral prophylaxis in this arm. | Oral antiviral prophylaxis (valganciclovir or ganciclovir) begun after transplant, given to high-risk (D+R-) recipients per guideline recommendations. |
| Role in trial | Investigational intervention tested for CMV prevention in the specified high-risk population. | Comparator arm receiving routine post-transplant care without immunoglobulin; all participants receive other routine transplant care per protocol. | Benchmark for current clinical practice; represents the guideline-recommended antiviral prophylaxis used outside this trial. |
| Primary use | Prevent late clinically significant CMV disease following kidney, liver, or liver-kidney transplant in high-risk D+R- recipients. | Compare CMV disease rate under routine care without immunoglobulin intervention, as trial control. | Reduce risk of CMV infection and disease in high-risk D+R- transplant recipients via antiviral prophylaxis, as established clinical practice. |
| How it is given or performed | CytoGam® given intravenously at 150 mg/kg, administered monthly for three months after transplant (Days 0, 28, and 56). | No investigational product given. Participants continue routine post-transplant monitoring. | Guidelines recommend oral valganciclovir (preferred), dosed daily for 3–6 months after transplant; ganciclovir IV is an alternative when oral is not feasible. |
| Evidence status | Evidence for immunoglobulin use in this population remains investigational; this trial will determine if additional CytoGam® reduces late CMV disease after transplant. | Trial registry does not report clinical outcome results yet. Published registry evidence pending study completion. | Multiple guidelines and systematic reviews confirm antiviral prophylaxis reduces CMV infection and disease in D+R- transplant recipients compared to placebo or no prophylaxis. |
| Important limitations | CytoGam® has potential risks of infusion reactions, anaphylaxis (especially in IgA-deficient patients), and cost/accessibility concerns. Registry notes restricted eligibility and exclusion for prior severe reactions. | No immunoglobulin is given; CMV risk may remain if effective prophylaxis is absent. Standard care as defined in the trial may not represent present-day best practice outside the study. | Antiviral prophylaxis can cause myelosuppression, anemia, renal toxicity, and risk of resistance. Guidelines note monitoring required; dose adjustment may be needed for kidney function. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Per Ljungman, Roy F Chemaly, Fareed Khawaya...
https://pubmed.ncbi.nlm.nih.gov/39041385/Raymund R Razonable, Atul Humar
https://pubmed.ncbi.nlm.nih.gov/30817026/Camille N Kotton, Deepali Kumar, Angela M Caliendo...
https://pubmed.ncbi.nlm.nih.gov/29596116/Jacqueline M McBride, Daniel Sheinson, Jenny Jiang...
https://pubmed.ncbi.nlm.nih.gov/30775403/Camille N. Kotton, MD
Lead Sponsor
University of Texas Southwestern Medical Center
Collaborating Sponsor
