Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Letermovir once daily · 1 trial · 2 indications
The incidence of cytomegalovirus viremia (defined as CMV PCR \> 137 units/ml) or symptomatic disease in AA kidney transplant recipients by one year post-transplantation
| Arm | Type | Description |
|---|---|---|
| Letermovir group (study group) | EXPERIMENTAL | Letermovir 480 mg once daily |
| Historical Control study group | OTHER | Historically matched AA kidney transplant recipients who received the standard of care 450mg once a day valganciclovir prophylaxis |
| Name | Type | Description |
|---|---|---|
| Letermovir 480 mg once daily | DRUG | We will test the study hypothesis in a single center, matched (1:1 fashion) pilot study of Letermovir 480 mg once daily versus historically matched AA kidney transplant recipients who received valganciclovir. We will enroll 30 AA patients over a 12-month period into the Letermovir group and compare outcomes to a historical group of 30 AA kidney transplant recipients who have received valganciclovir prophylaxis (1:1 fashion), for a total of 60 patients. We will attempt to match patients on Letermovir to the historical patients who received valganciclovir, based on age, kidney Donor profile index and the presence of panel of reactive antibodies. |
| Historical/Control | OTHER | The control study group will include high-risk African American kidney transplant recipients cared for with Valganciclovir in the 5 years prior to the enrollment start for the study group. This time frame is based upon the current volume of transplants done at VCU. On average 30 liver and/or kidney transplants are done per month. Thus, 5 years should be an adequate time frame to mine enough number of participants to answer our primary research hypothesis. |
Historical Control group: Inclusion Criteria 1. Kidney transplant recipients 2. Male or female age ≥ 18 years old 3. African American race 4. CMV high risk (D+/R-) 5. received valganciclovir for CMV prophylaxis Historical Control group: Exclusion 1. Re-transplantation 2. Panel of reactive antib...