Actively Recruiting
Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Disease in Chinese Kidney Transplant Recipients
Led by First Affiliated Hospital Xi'an Jiaotong University · Updated on 2025-12-05
290
Participants Needed
1
Research Sites
80 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital Xi'an Jiaotong University
Lead Sponsor
C
Chinese People's Liberation Army Northern Theater Command General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Disease in Chinese Kidney Transplant Recipients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, any gender.
- Receiving the first kidney transplant.
- Within 0 to 7 days after kidney transplant at time of randomization.
- Signed informed consent obtained.
You will not qualify if you...
- Previous solid organ or hematopoietic stem cell transplant.
- Multi-organ transplant recipient (e.g., kidney-pancreas) or double kidney transplant.
- History or suspected CMV disease within 6 months before randomization.
- Evidence of CMV virus in blood from consent signing or transplant until randomization.
- Known allergy to letermovir, valganciclovir, ganciclovir, or their ingredients.
- On dialysis or plasmapheresis at randomization (except if stopped within 7 days post-transplant and expected to remain off).
- Post-transplant kidney function with creatinine clearance below 10 mL/min at randomization.
- Severe liver disease (Child-Pugh Class C) at screening.
- Moderate liver disease plus moderate-to-severe kidney insufficiency at screening.
- Any uncontrolled infection on day of randomization.
- Positive HIV antibody test anytime before randomization.
- Positive hepatitis C antibody with detectable virus RNA within 90 days before randomization.
- Positive hepatitis B surface antigen within 90 days before randomization.
- Requires mechanical ventilation or unstable blood circulation at randomization.
- History of cancer in last 5 years except certain treated skin or cervical cancers.
- Pregnant, breastfeeding, or plans to breastfeed during study and 90 days after treatment.
- Conditions or treatments that could affect study results or safety as judged by investigator.
- Low blood counts or abnormal liver tests at screening (specific lab value thresholds).
- Recent or planned anti-CMV antibody or drug treatments within specified time frames.
- Expected to receive traditional Chinese medicine or herbal treatments during study and 14 days after.
- Participation in another investigational study within 28 days or 5 half-lives of prior drug.
- Previous or current participation in CMV vaccine or investigational CMV agent studies.
- Immediate family member involved in this study as site or sponsor staff.
AI-Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, China, 710000
Actively Recruiting
Research Team
X
Xiaoming Ding
CONTACT
Y
Yihan Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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