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

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.

NCT Number	NCT07266467
Lead Sponsor	First Affiliated Hospital Xi'an Jiaotong University Collaborators: Chinese People's Liberation Army Northern Theater Command General Hospital, The First Hospital of Jilin University, The Affiliated Hospital of Qingdao University, Qianfo Mountain Hospital, Shandong Province, The First Affiliated Hospital of Anhui Medical University, Eastern Theater General Hospital, Shu lan Hospital, Shanghai Zhongshan Hospital, Tongji Hospital, The Second Xiangya Hospital, Central South University, The First Affiliated Hospital of Zhengzhou University, Second Affiliated Hospital of Guangzhou Medical University, First Affiliated Hospital, Sun Yat-Sen University, Beijing Chao Yang Hospital, RenJi Hospital, Nanfang Hospital, Southern Medical University, Beijing Tsinghua Changgeng Hospital
Conditions	Kidney Transplant
Enrollment	290 participants
Start Date	2025-05-13
Primary Completion	2026-11-30 (estimated)
Study Completion	2026-11-30 (estimated)
Updated on ClinicalTrials.gov	2025-12-05