Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV) (NCT06958796) | Clinical Trial Compass
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 range18 Years – 75 Years
SexALL
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…
What they're measuring
1
Number of Participants with Late Clinically Significant CMV Disease
Timeframe: Treatment Phase (Day 0) through End of Study (Day 168)
2
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)