Actively Recruiting
Letermovir/Valganciclovir Combination Versus Valganciclovir Monotherapy for Treatment of Cytomegalovirus (CMV) Infections in Kidney Transplant Recipients
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-02
80
Participants Needed
5
Research Sites
8 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and tolerability of letermovir combined with valganciclovir in kidney transplant patients who have cytomegalovirus (CMV) infections. This study aims to see if dual therapy with letermovir and valganciclovir can control CMV infection better and reduce the chance of drug resistance compared to valganciclovir alone. The trial is a randomized, phase 3 study involving kidney transplant recipients with CMV DNAemia needing valganciclovir treatment. Participants will be randomly assigned to receive either daily oral doses of letermovir plus valganciclovir or a placebo with valganciclovir. Letermovir is given at 480 mg once daily, with dosage adjustments if cyclosporine A is co-administered. Valganciclovir is given at 900 mg twice daily, with dose adjustments for impaired kidney function. Treatment continues until the participant meets criteria for treatment success or failure, up to 12 weeks. Throughout the study, participants will have blood tests to monitor CMV levels and assess treatment response, including measuring CMV DNAemia at week 3 and week 12. Researchers will also evaluate clinical symptoms, adverse events, drug concentrations, viral gene sequencing, and immune response over 12 weeks. The primary outcome is the virological response at week 3, and safety and effectiveness will be closely monitored during the study period.
CONDITIONS
Brief Title
Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Weight 30 kg or more
- Kidney transplant recipient
- Documented CMV infection or disease with specific CMV DNA levels in blood or plasma
- Eligible for oral valganciclovir treatment
- For patients of childbearing age: negative pregnancy test and use of effective contraception
- For male patients: use of effective contraception
- Life expectancy of at least 8 weeks
- French speaking
- Affiliated with social security or equivalent
- Signed informed consent
You will not qualify if you...
- Current CMV infection refractory or resistant due to poor antiviral adherence
- Known genotypic resistance to valganciclovir or letermovir
- Treatment with anti-CMV agents for current infection longer than 72 hours (except prophylaxis cases)
- Estimated glomerular filtration rate (eGFR) below 15 mL/min/1.73m²
- Liver enzymes (AST or ALT) or bilirubin levels significantly elevated beyond set limits, except Gilbert's syndrome
- Severe chronic liver disease (Child-Pugh Class C)
- Known HIV infection with detectable viral load in past 3 months
- Need for mechanical ventilation or vasopressor support
- Pregnancy or breastfeeding
- Previous anti-CMV vaccine
- Use of leflunomide or artesunate at treatment start
- Use of strong CYP enzyme inhibitors or inducers at treatment start
- Use of specific interacting medications at treatment start
- Known hereditary intolerance to galactose or related conditions
- Known hypersensitivity to letermovir or study excipients
- Any medical or surgical condition interfering with study or safety
- Participation in another clinical trial of medicinal products
- Low blood counts below specified thresholds
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 weeks
Participants receive daily oral treatment with either letermovir plus valganciclovir or letermovir placebo plus valganciclovir until treatment success or failure, up to 12 weeks.
Weekly visits for up to 12 weeks
Trial Site Locations
Total: 5 locations
1
Hôpital Necker Enfants Malades
Paris, France, 75015
Actively Recruiting
2
Hôpital de la Pitié Salpêtrière, Service de Néphrologie
Paris, Île-de-France Region, France, 75013
Actively Recruiting
3
Hôpital Européen Georges Pompidou
Paris, Île-de-France Region, France, 75015
Actively Recruiting
4
Hôpital Necker Enfants Malades - SMIT
Paris, Île-de-France Region, France, 75015
Actively Recruiting
5
Centre 011-Hôpital Bichat, Service de Néphrologie
Paris, Île-de-France Region, France, 75018
Actively Recruiting
Research Team
P
Pierre FRANGE, MD, PhD
A
Aminata TRAORE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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