Letermovir-based Dual Therapy for Treatment of Cytomegalovirus Infections
ConditionCytomegalovirus Infection
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
The purpose of this study is to evaluate the efficacy and the tolerance of letermovir as part of dual antiviral therapy (in association with valganciclovir) in renal transplant recipients with CMV DNAemia, requiring valganciclovir treatment per investigator's judgment.
Eligibility criteria
Qualifiers
Age ≥ 18 years
Weight ≥ 30 kg
Kidney transplant recipient
Have a documented CMV infection or disease, with (i) a screening value of CMV DNA ≥ 3000 IU/mL in whole blood or plasma in 2 consecutive assessments separated by ≥ 1 day, as determined by local laboratory quantitative polymerase chain reaction (qPCR). Both samples should be taken within 14 days prior to randomization with the second sample obtained within 5 days prior to randomization OR (ii) a screening value of CMV DNA ≥ 30000 IU/mL in whole blood or plasma, as determined by local laboratory quantitative polymerase chain reaction (qPCR), in 1 sample obtained within 5 days prior to randomization
Disqualifiers
Have a current CMV infection that is considered refractory or resistant due to inadequate adherence to antiviral treatment, to the best knowledge of the investigator.
Have a CMV infection that is known to be genotypically resistant to valganciclovir and/or letermovir on documented evidence.
Be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet, cidofovir, letermovir or maribavir) for the current CMV infection for longer than 72 hours. However, patients experiencing CMV infection while receiving ganciclovir or valganciclovir prophylaxis (i.e. at prophylactic dosages) or letermovir prophylaxis can be included.
Have an eGFR < 15 mL/min/1.73m² (using the CKD-EPI Creatinine Equation (2009)).
Trial design
Treatments tested in this trial
- Letermovir
- Valganciclovir
- Letermovir placebo
Treatment groups
80 Participants
are divided into 2 treatment groupsLocations
5Centre 011-Hôpital Bichat, Service de Néphrologie75018, ParisÎle-de-France Region, France
Hôpital de la Pitié Salpêtrière, Service de Néphrologie75013, ParisÎle-de-France Region, France
Hôpital Européen Georges Pompidou75015, ParisÎle-de-France Region, France
Hôpital Necker Enfants Malades - SMIT75015, ParisÎle-de-France Region, France
Sponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
URC-CIC Paris Descartes Necker Cochin
Collaborator
Source ClinicalTrials.gov