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Letermovir vs Valganciclovir for CMV Prevention in Kidney Transplant
NCT03443869Phase 3
Key facts
- Status
- Completed
- Start
- May 2018
- Primary completion
- Apr 2022
- Countries
- 16
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- letermovir
- Conditions
- cytomegalovirus disease (CMV)
01
Overview
Phase 3, randomised, double-blind trial of letermovir in cytomegalovirus disease (CMV) (2 arms), sponsored by Merck & Co. Primary endpoint: Percentage of Participants With Adjudicated Cytomegalovirus (CMV) Disease Through 52 Weeks Post-transplant. Started May 2018; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Letermovir
Letermovir + Acyclovir + Placebo to VGCV
Valganciclovir
Valganciclovir + Placebo to LET + Placebo to ACV
03
Who it enrols
Adult kidney transplant recipients (D+/R-) within 7 days post-transplant, excluding those with prior CMV disease, severe hepatic insufficiency, or active infections.
04
Endpoints
Primary
Percentage of Participants With Adjudicated Cytomegalovirus (CMV) Disease Through 52 Weeks Post-transplant
Secondary
Percentage of Participants With Adjudicated CMV Disease Through 28 Weeks Post-transplant
Time to Onset of Adjudicated CMV Disease Through 52 Weeks Post-transplant
Percentage of Participants With Any AE
Percentage of Participants With Any Drug-related Serious Adverse Event (SAE)
05
Results
Primary endpoints met
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