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

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.

Eligibility

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 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)
* Any history of acute myocardial infarction (within 12 months of screening), clinically significant arrythmia, or clinically significant ECG abnormality in the opinion of the investigator at time of screening
* History of active or latent tuberculosis (except those who have completed a documented regimen for latent TB treatment) or severe pulmonary disease \[e.g., severe pulmonary hypertension (WHO class IV)\] that in the opinion of the investigator that may preclude their ability to safely tolerate study infusions
* Any history of neurodegenerative disease, including dementia, or stroke with substantial residual disability (modified Rankin score ≥ 3)
* Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test.
* Women of childbearing potential unless using a highly effective method of contraception during dosing and for 24 weeks after study treatment. Medically acceptable birth control (contraceptives) includes but are not limited to: surgical sterilization (such as hysterectomy or "tubes tied"), approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Depo-Lupron, lmplanon), barrier methods (such as condom or diaphragm), an intrauterine device (IUD), abstinence from sex.
* Any significant history of any treatment nonadherence or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk
* Subjects who have any of the following 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; Alanine aminotransferase (ALT) \>5 x upper limit of normal; Aspartate aminotransferase (AST)\] \>5 x upper limit of normal; CMV IgG negative in donor or positive in recipient

Conditions6

Locations2 sites

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