RecruitingPhase 4

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

China290 participantsStarted 2025-05-13

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- 1) Age ≥18 years old, gender unlimited. 2) Receiving the first kidney transplant. 3) Be within 0 (ie, day of transplantation) to 7 days (inclusive) post-kidney transplant at the time of randomization. 4\) Obtain informed consent signed . Exclusion Criteria: * 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. 3)Has a history of CMV disease or suspected CMV disease within 6 months prior to randomization. 4)Has evidence of CMV viremia at any time from the signing of the ICF or the transplant procedure until the randomization period; 5)Has suspected or known hypersensitivity to active or inactive ingredients of LET formulations, VGCV, GCV, formulations. 6)Is on dialysis or plasmapheresis at the time of randomization. Note: For the purposes of this protocol, dialysis includes hemofiltration. Participant who: (1) has had dialysis or plasmapheresis within 7 days (inclusive) post-transplant but is not on dialysis or plasmapheresis at the time of randomization; and (2) is expected to remain off dialysis or plasmapheresis may be enrolled, provided that all other inclusion/exclusion criteria are met. 7)Has post-transplant renal function of CrCI 10 mL/min at randomization (measured) locally). For this exclusion criterion, CrCl will be ca…

What they're measuring

Incidence of CMV disease at 52 weeks after transplantation

Timeframe: 52 weeks after transplantation

Trial details

NCT IDNCT07266467

SponsorFirst Affiliated Hospital Xi'an Jiaotong University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-30

Contact for this trial

Xiaoming Ding

+86 13991238632 xmding1970@163.com