LET vs VGCV to Prevent CMV disease in Kidney Transplant Recipient
Research type
Research Study
Full 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
IRAS ID
238648
Contact name
Joyce Popoola
Contact email
Sponsor organisation
Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc.
Eudract number
2017-001055-30
Clinicaltrials.gov Identifier
IND number, 104,706 (tablet IND); 118,361 (IV IND)
Duration of Study in the UK
3 years, 2 months, 7 days
Research summary
Summary of Research
Cytomegalovirus (CMV) is a virus which causes infection and disease with clinical complications and increased risk of death among patients receiving solid organ transplant (SOT).
CMV prophylaxis is widely used following SOT and is associated with reductions in CMV disease, death and transplant rejection. Ganciclovir (GCV) and valganciclovir (VGCV) are currently used for CMV prophylaxis although both are linked to myelosuppression (a condition in which bone marrow activity is decreased, resulting in fewer red blood cells, white blood cells and platelets). CMV strains resistant to GCV/VGCV have also been identified. GCV is renally cleared so changes in kidney function (resulting from, for example, kidney transplant) may lead to over exposure to the medicine and increased risk of toxicity. There is therefore an unmet medical need for new agents which do not cause myelosuppression, are dosed independent of kidney function and are active against GCV-resistant CMV. MK-8228 (also known as letermovir (LET)) belongs to a new class of anti-CMV agents that exhibit some of these properties.
This Phase III randomised, double-blinded interventional study will evaluate the effectiveness and safety of LET compared to VGCV in the prevention of CMV disease in approximately 600 male/female kidney transplant participants.
Participants will participate for 52-54 weeks and will be assigned to 1 of 2 treatment arms:
Arm 1: LET 240 mg or 480 mg once daily (QD), if given concomitantly with cyclosporin A, with VGCV matching placebo, and acyclovir.
Arm 2: VGCV QD or GCV QD with LET matching placebo and acyclovir matching placebo.
Treatments will start within 7 days post-transplant and continue through Week 28. After 28 weeks, participants will be followed through Week 52 to assess for CMV disease and DNAemia.
This study is funded by Merck Sharp & Dohme Limited and will take place at one study centre in the UK.Summary of Results
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REC name
Wales REC 1
REC reference
18/WA/0057
Date of REC Opinion
8 Mar 2018
REC opinion
Further Information Favourable Opinion