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.
None
1)Received a previous solid organ transplant or HSCT. 2)Is a multi-organ transplant recipient (eg, kidney-pancreas). Note: Double kidney transplant recipients (ie, transplant of two kidneys from the same donor to the same recipient simultaneously) will be excluded.
Parallel
Letermovir
DrugDrug name: Letermovir.
Valganciclovir
DrugValganciclovir.
Incidence of CMV disease at 52 weeks after transplantation
Proportion of subjects diagnosed with CMV disease at week 52 after transplantation.
Incidence of CMV disease at 14/24 weeks after transplantation
Proportion of subjects diagnosed with CMV disease at week 14/26 after transplantation.
Time of CMV onset 52 weeks after transplantation
From the day of transplant to the first diagnosis of CMV disease.
Incidence of CMV DNaemia at 14/26/52 weeks after transplantation
Proportion of subjects diagnosed with CMV DNaemia at week 14/26/52 after transplantation.
Incidence and severity of all adverse events
Proportion of subjects with any AE that occurred from the time the study intervention was assigned to 14 days after the study intervention was terminated. Saes will only be reported 14 days after stopping the study intervention until week 52 after transplantation.
Click on the lead sponsor to view all of their trials.
First Affiliated Hospital Xi'an Jiaotong University
Lead sponsor
Chinese People's Liberation Army Northern Theater Command General Hospital
Collaborator
The First Hospital of Jilin University
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Qianfo Mountain Hospital, Shandong Province
Collaborator
The First Affiliated Hospital of Anhui Medical University
Collaborator
Eastern Theater General Hospital
Collaborator
Shu lan Hospital
Collaborator
Shanghai Zhongshan Hospital
Collaborator
Tongji Hospital
Collaborator
The Second Xiangya Hospital, Central South University
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Second Affiliated Hospital of Guangzhou Medical University
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
Beijing Chao Yang Hospital
Collaborator
RenJi Hospital
Collaborator
Nanfang Hospital, Southern Medical University
Collaborator
Tsinghua Changgeng Hospital, Beijing
Collaborator
