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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
601
LET 480mg (or 240 mg when administered concomitantly with cyclosporin A) once daily for 28 weeks
900 mg VGCV tablet orally, once daily for 28 weeks
400 mg over-encapsulated ACV tablet orally, every 12 hours for 28 weeks
Percentage of Participants With Adjudicated Cytomegalovirus (CMV) Disease Through 52 Weeks Post-transplant
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.
Time frame: Up to 52 weeks
Percentage of Participants With Adjudicated CMV Disease Through 28 Weeks Post-transplant
CMV disease was defined as the presence of either CMV end-organ disease or CMV syndrome and was confirmed by an independent, blinded 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.
Time frame: Up to 28 weeks
Time to Onset of Adjudicated CMV Disease Through 52 Weeks Post-transplant
The time to onset of adjudicated CMV disease was calculated in days, from the day of randomization to the day of onset of CMV disease as determined by the CAC.
Time frame: Up to 52 weeks
Percentage of Participants With Any AE
An AE was defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE.
Time frame: Up to 52 weeks
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Over-encapsulated placebo tablet orally, every 12 hours for 28 weeks
Placebo to LET tablet orally, once daily for 28 weeks
Placebo to VGCV tablet orally, once daily for 28 weeks
UAB ( Site 0269)
Birmingham, Alabama, United States
UCLA Medical Center ( Site 0266)
Los Angeles, California, United States
UC Davis Medical Center ( Site 0271)
Sacramento, California, United States
University of California-San Francisco ( Site 0236)
San Francisco, California, United States
Stanford Health Care ( Site 0235)
Stanford, California, United States
The Emory Clinic ( Site 0247)
Atlanta, Georgia, United States
University of Chicago ( Site 0251)
Chicago, Illinois, United States
Indiana University ( Site 0261)
Indianapolis, Indiana, United States
Ochsner Clinic Foundation ( Site 0238)
New Orleans, Louisiana, United States
University of Maryland Medical Center ( Site 0234)
Baltimore, Maryland, United States
...and 84 more locations
Percentage of Participants With Any Drug-related Serious Adverse Event (SAE)
An SAE was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event. SAEs that the investigator determined the relationship of the AE to the treatment as at least possibly related were reported.
Time frame: Up to 52 weeks