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NCT03443869 · ClinicalTrials.gov registry record · Phase 3
Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)
A Phase 3 study, sponsored by Merck Sharp & Dohme.
- Completed
- Registry status
- Phase 3
- Development phase
- 601
- Enrollment target
NCT03443869: Completed Phase 3 study, sponsored by Merck Sharp & Dohme.
NCT03443869 is a Phase 3 study that has completed, run by Merck Sharp & Dohme. The registered enrollment target is 601 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03443869, a Phase 3 study, has completed, sponsored by Merck Sharp & Dohme.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 601 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior to VGCV, in preventing CMV disease through 52 weeks post-transplant.
Primary Outcome
CMV disease was defined as the presence of either CMV end-organ disease or CMV syndrome and was confirmed by an independent, blinded Clinical Adjudication Committee (CAC). Only CAC-confirmed ("adjudicated") cases were included in percentage of participants who met the endpoint. Investigator-assessed cases which were not confirmed by the CAC were not included.
Interventions
- DRUG Letermovir
- DRUG Valganciclovir
- DRUG Acyclovir (ACV)
- DRUG Placebo to ACV
- DRUG Placebo to LET
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 601 participants |
| Start Date | 2018-05-03 |
| Est. Completion | 2022-04-05 |
| Phase | Phase 3 |
What the finished NCT03443869 record still lists
NCT03443869 is an interventional study that assigns participants to a tested intervention. The registered 601 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 5 interventions - of which Letermovir is the first listed.
NCT03443869 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03443869 about?
NCT03443869 is a clinical study titled "Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)". The primary objective of this study is to evaluate the efficacy of letermovir (LET) versus valganciclovir (VGCV) in preventing CMV disease in adult kidney transplant recipients. The primary hypotheses are that LET is non-inferior to VGCV; and if non-inferiority is demonstrated, that LET is superior ...
What is the current status of trial NCT03443869?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 601 participants. The study started on 2018-05-03. Estimated completion is 2022-04-05.
What interventions are being tested in trial NCT03443869?
The interventions under investigation include: Letermovir (DRUG), Valganciclovir (DRUG), Acyclovir (ACV) (DRUG), Placebo to ACV (DRUG), Placebo to LET (DRUG).
Who is sponsoring clinical trial NCT03443869?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03443869's enrollment target sits among peer trials
601 608th of 2000 higher than 1,393 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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