Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)
Public ClinicalTrials.gov record NCT03443869. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of MK-8228 (Letermovir) Versus Valganciclovir for the Prevention of Human Cytomegalovirus (CMV) Disease in Adult Kidney Transplant Recipients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03443869
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 601 participants
Conditions and interventions
Conditions
Interventions
- Letermovir Drug
- Valganciclovir Drug
- Acyclovir (ACV) Drug
- Placebo to ACV Drug
- Placebo to LET Drug
- Placebo to VGCV Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 3, 2018 (Actual)
- Primary completion
- Apr 5, 2022 (Actual)
- Completion
- Apr 5, 2022 (Actual)
- Last update posted
- Jul 28, 2023
2018 – 2022
United States locations
- U.S. sites
- 27
- U.S. states
- 19
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB ( Site 0269) | Birmingham | Alabama | 35233 | — |
| UCLA Medical Center ( Site 0266) | Los Angeles | California | 90095 | — |
| UC Davis Medical Center ( Site 0271) | Sacramento | California | 95817 | — |
| University of California-San Francisco ( Site 0236) | San Francisco | California | 94143 | — |
| Stanford Health Care ( Site 0235) | Stanford | California | 94305 | — |
| The Emory Clinic ( Site 0247) | Atlanta | Georgia | 30322 | — |
| University of Chicago ( Site 0251) | Chicago | Illinois | 60637 | — |
| Indiana University ( Site 0261) | Indianapolis | Indiana | 46202 | — |
| Ochsner Clinic Foundation ( Site 0238) | New Orleans | Louisiana | 70121 | — |
| University of Maryland Medical Center ( Site 0234) | Baltimore | Maryland | 21201 | — |
| Johns Hopkins Hospital ( Site 0232) | Baltimore | Maryland | 21287 | — |
| Brigham & Women's Hospital ( Site 0244) | Boston | Massachusetts | 02115 | — |
| Henry Ford Hospital ( Site 0242) | Detroit | Michigan | 48202 | — |
| University of Nebraska Medical Center ( Site 0272) | Omaha | Nebraska | 68198 | — |
| Saint Barnabas Medical Center ( Site 0250) | Livingston | New Jersey | 07039 | — |
| Icahn School of Medicine at Mount Sinai ( Site 0256) | New York | New York | 10029 | — |
| Columbia University Medical Center ( Site 0255) | New York | New York | 10032 | — |
| New York Presbyterian Hospital - Weill Cornell Medical Center ( Site 0276) | New York | New York | 10065 | — |
| Duke University Medical Center ( Site 0243) | Durham | North Carolina | 27710 | — |
| Wake Forest University Baptist Medical Center ( Site 0260) | Winston-Salem | North Carolina | 27157 | — |
| The Ohio State University Wexner Medical Center ( Site 0264) | Columbus | Ohio | 43210 | — |
| University of Pennsylvania ( Site 0270) | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh ( Site 0252) | Pittsburgh | Pennsylvania | 15213 | — |
| Medical University of South Carolina ( Site 0257) | Charleston | South Carolina | 29425 | — |
| Vanderbilt University Medical Center ( Site 0275) | Nashville | Tennessee | 37232 | — |
| Virginia Commonwealth University ( Site 0245) | Richmond | Virginia | 23298 | — |
| University of Washington Medical Center ( Site 0246) | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 67 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03443869, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 28, 2023 · Synced Oct 17, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03443869 live on ClinicalTrials.gov.