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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03443869
Registration number
NCT03443869
Ethics application status
Date submitted
19/02/2018
Date registered
23/02/2018
Titles & IDs
Public title
Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)
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Scientific 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
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Secondary ID [1]
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MK-8228-002
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Secondary ID [2]
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8228-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
CMV Disease
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Letermovir
Treatment: Drugs - Valganciclovir
Treatment: Drugs - Acyclovir (ACV)
Treatment: Drugs - Placebo to ACV
Treatment: Drugs - Placebo to LET
Treatment: Drugs - Placebo to VGCV
Experimental: Letermovir - LET 480mg (or 240 mg when administered concomitantly with cyclosporin A) tablet orally; placebo to VGCV tablet orally once daily; and 400 mg capsule of acyclovir (ACV) orally every 12 hours for 28 weeks
Active comparator: Valganciclovir - 900 mg VGCV tablet orally, once daily; placebo to LET tablet orally once daily; and placebo to ACV orally every 12 hours for 28 weeks
Treatment: Drugs: Letermovir
LET 480mg (or 240 mg when administered concomitantly with cyclosporin A) once daily for 28 weeks
Treatment: Drugs: Valganciclovir
900 mg VGCV tablet orally, once daily for 28 weeks
Treatment: Drugs: Acyclovir (ACV)
400 mg over-encapsulated ACV tablet orally, every 12 hours for 28 weeks
Treatment: Drugs: Placebo to ACV
Over-encapsulated placebo tablet orally, every 12 hours for 28 weeks
Treatment: Drugs: Placebo to LET
Placebo to LET tablet orally, once daily for 28 weeks
Treatment: Drugs: Placebo to VGCV
Placebo to VGCV tablet orally, once daily for 28 weeks
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Adjudicated Cytomegalovirus (CMV) Disease Through 52 Weeks Post-transplant
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 52 weeks
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Secondary outcome [1]
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Percentage of Participants With Adjudicated CMV Disease Through 28 Weeks Post-transplant
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 28 weeks
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Secondary outcome [2]
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Time to Onset of Adjudicated CMV Disease Through 52 Weeks Post-transplant
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 52 weeks
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Secondary outcome [3]
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Percentage of Participants With Any AE
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Assessment method [3]
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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.
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Timepoint [3]
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Up to 52 weeks
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Secondary outcome [4]
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Percentage of Participants With Any Drug-related Serious Adverse Event (SAE)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 52 weeks
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Eligibility
Key inclusion criteria
* Have a documented negative serostatus for CMV within 180 days prior to randomization.
* Anticipate receiving a primary or secondary allograft kidney from a CMV IgG seropositive (D+) donor at the time of screening AND have received a primary or secondary allograft kidney from a documented D+ donor at the time of randomization.
* Be within 0 (i.e. day of transplantation) to 7 days (inclusive) post-kidney transplant at the time of randomization.
* Males agree to use contraception during the treatment period, and for at least 90 days after the last dose of study treatment, and refrain from donating sperm during this period.
* Female is not pregnant, not breastfeeding, and is not a woman of childbearing potential (WOCBP), OR if a WOCBP, agrees to follow the contraception guidance during the treatment period and for at least 90 days after the last dose of study treatment.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Has received a previous solid organ transplant or hematopoietic stem cell transplant (HSCT). Note: Participants who have received a prior primary allograft kidney may be enrolled, provided that all other inclusion/exclusion criteria are met.
* Is a multi-organ transplant recipient (e.g. kidney-pancreas). Double kidney transplant recipients (i.e. transplant of two kidneys from the same donor to the same recipient simultaneously) will be excluded.
* Has a history of CMV disease or suspected CMV disease within 6 months prior to randomization.
* Has suspected or known hypersensitivity to active or inactive ingredients of LET formulations, VGCV, GCV, and/or ACV formulations.
* Is on dialysis or plasmapheresis at the time of randomization. Dialysis includes hemofiltration.
* Has Child-Pugh Class C severe hepatic insufficiency at screening.
* Has both moderate hepatic insufficiency AND moderate-to-severe renal insufficiency at screening.
* Has any uncontrolled infection on the day of randomization.
* Has documented positive results for human immunodeficiency virus antibody (HIV-Ab) test at any time prior to randomization, or for hepatitis C virus antibody (HCV-Ab) and with detectable HCV ribonucleic acid (RNA) within 90 days prior to randomization, or hepatitis B surface antigen (HBsAg) within 90 days prior to randomization.
* Requires mechanical ventilation, or is hemodynamically unstable, at the time of randomization.
* Has a history of malignancy =5 years prior to signing informed consent.
* Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through at least 90 days following cessation of study therapy.
* Is expecting to donate eggs or sperm starting from the time of consent through at least 90 days following cessation of study therapy.
* Has received within 30 days prior to randomization or plans to receive during the study any of the following anti-CMV IgG antibody treatment or anti-CMV drug therapy including the following: Cidofovir, CMV hyper-immune globulin, Any investigational CMV antiviral agent/biologic therapy.
* Has received within 7 days prior to randomization or plans to receive during the study any of the following anti-CMV drug therapy: LET, GCV, VGCV, Foscarnet, ACV, Valacyclovir, Famciclovir.
* Is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence.
* Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5× half-life of the investigational compound whichever is longer, of initial dosing on this study.
* Has previously participated in this study or any other study involving LET.
* Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/05/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
5/04/2022
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Sample size
Target
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Accrual to date
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Final
601
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital ( Site 0005) - Camperdown
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Westmead Hospital ( Site 0006) - Westmead
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Princess Alexandra Hospital ( Site 0004) - Woolloongabba
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Royal Adelaide Hospital ( Site 0003) - Adelaide
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Monash Health-Monash Medical Centre ( Site 0008) - Clayton
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Royal Melbourne Hospital ( Site 0007) - Parkville
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2050 - Camperdown
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2145 - Westmead
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4102 - Woolloongabba
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5000 - Adelaide
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3168 - Clayton
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3050 - Parkville
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Funding & Sponsors
Primary sponsor type
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Name
Merck Sharp & Dohme LLC
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT03443869
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Trial related presentations / publications
Limaye AP, Budde K, Humar A, Vincenti F, Kuypers DRJ, Carroll RP, Stauffer N, Murata Y, Strizki JM, Teal VL, Gilbert CL, Haber BA. Letermovir vs Valganciclovir for Prophylaxis of Cytomegalovirus in High-Risk Kidney Transplant Recipients: A Randomized Clinical Trial. JAMA. 2023 Jul 3;330(1):33-42. doi: 10.1001/jama.2023.9106.
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Public notes
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Contacts
Principal investigator
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Merck Sharp & Dohme LLC
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/69/NCT03443869/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/69/NCT03443869/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Limaye AP, Budde K, Humar A, Vincenti F, Kuypers D...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT03443869