Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Disease in Chinese Kidney Transplant Recipients

Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Study ID
NCT07266467
Phase
PHASE4
Status
Recruiting
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Conditions

  • Kidney Transplant

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Letermovir — DRUG
    Drug name: Letermovir.
  • Valganciclovir — DRUG
    Valganciclovir.

Study Details

the existing anti-CMV drugs mainly include valganciclovir, ganciclovir and foscarnet sodium, all of which act on DNA polymerase (pUL54), making them prone to cross resistance. DNA synthesis in normal cell is also catalyzed by DNA polymerase, which can also inhibit normal cell production, especially in metabolically active bone marrow cells, leading to bone marrow suppression. In addition, these drugs are mainly metabolized by the kidneys, causing damage to proximal renal tubular cells. Therefore, it is necessary to closely monitor the patient's renal function and adjust the dosage. Overall, the medical demand for effective and well-tolerated treatment methods for CMV infection management in kidney transplant recipients remains unmet, and safer anti-CMV drugs are urgently needed. The target of letemovir is the CMV DNA terminal enzyme complex, which is different from the target of existing anti-CMV drugs, and does not exhibit cross resistance. Moreover, this target does not have a corresponding substance in mammalian cells and does not exhibit toxicity similar to DNA polymerase targets. In addition, letemovir is mainly metabolized by the liver, and urinary excretion can be ignored (\<2% dose), so there is no need to adjust the dose according to renal function. Phase III registered clinical studies abroad have shown that letemovir is not inferior to valganciclovir in preventing CMV disease in kidney transplant recipients. Additionally, letemovir is safer and has a lower incidence of adverse reactions, especially leukopenia or granulocytopenia. However, there is still a lack of data on the use of kidney transplantation in Chinese population. The aim of this study was to evaluate the efficacy and safety of letamovir in preventing CMV infection and CMV disease in kidney transplant recipients in China.

Key Dates

First listed
Dec 5, 2025
Start date
May 13, 2025
Status verified
Mar 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
290 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Valganciclovir
    Experimental drug: Valganciclovir. Dose: 450mg. Dosing interval: once daily. Route of administration: oral. Course of treatment: Starting within 7 days (random day) after kidney transplantation and continuing until the 14th week (about 100 days) after transplantation.
  • Active Comparator: Letermovir
    Drug name: Letermovir. Dose: 480mg. Dosing interval: once daily. Route of administration: oral. Course of treatment: Starting within 7 days (random day) after kidney transplantation and continuing until the 14th week (about 100 days) after transplantation.

Primary Outcome Measure

Incidence of CMV disease at 52 weeks after transplantation [ Time Frame: 52 weeks after transplantation ]

Central Contacts

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