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RecruitingCytomegalovirusOrgan TransplantKidney Transplant; Complications

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

Eligible age

18–75 yrs

Accepts

All genders

Locations

2 states

Healthy volunteers

No

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About this study

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.

Sponsor: Camille N. Kotton, MD

You may qualify if…

  • ✓ 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

You may not qualify if…

  • ✕ 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 preparations
  • ✕ Individuals with a history of selective immunoglobulin A deficiency will be excluded, as they may produce antibodies against immunoglobulin A, leading to potential anaphylactic reactions upon receiving blood products containing immunoglobulin A, such as CMV immunoglobulin (e.g. CytoGam® or similar)

Where it's recruiting

Massachusetts

Boston

Texas

Dallas

Source: ClinicalTrials.gov · NCT06958796 · last updated 2025-12-22

Strategic Help With Immunoglobulin to Enhance Protect Against Late Dis · TrialPath