Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)
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.
| Condition(s) | Cytomegalovirus, Organ Transplant, Kidney Transplant; Complications, Liver Transplant Complications, Simultaneous Liver-Kidney Transplantation; Complications |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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 | 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 |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Camille N. Kotton, MD |
| Locations | Boston, Massachusetts, United States; Dallas, Texas, United States |
| Start date | 2025-11-27 |
| NCT ID | NCT06958796 |
| Official listing | https://clinicaltrials.gov/study/NCT06958796 |