Kidney TransplantPhase 4CAPS01NCT07266467
Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Disease in Chinese Kidney Transplant Recipients
A Phase 4 study testing Letermovir and Valganciclovir in people with Kidney Transplant, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- Letermovir and Valganciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2025to 30 Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 .
Who cannot join
- 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 calculated using the Cockcroft-Gault equation using the most recently obtained and available serum creatinine value collected within 3 calendar days prior to and including the day of randomization and after the conclusion of any clinically warranted (at the discretion of the investigator) post-transplant dialysis or plasmapheresis.
- 8)Has Child-Pugh Class C severe hepatic insufficiency at screening. 9)Has both moderate hepatic insufficiency AND moderate-to-severe renal insufficiency at screening.
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- Note: Moderate hepatic insufficiency is defined as Child-Pugh Class B. moderate-to-severe renal insufficiency is defined as CrCl <50 mL/min, as calculated by the Cockcroft-Gault equation, respectively.
- 10)Has any uncontrolled infection on the day of randomization. 11)Has documented positive results for human immunodeficiency virus antibody (HIV-Ab) test at any time prior to randomization, or for hepatitis C virus antibody (HCV-Ab) and with detectable HCV ribonucleic acid (RNA) within 90 days prior to randomization or hepatitis B surface antigen (HBsAg) within 90 days prior to randomization.
- 12)Requires mechanical ventilation, or is hemodynamically unstable, at the time of randomization.
- 13)Has a history of malignancy 5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or is under evaluation for other active or suspected malignancy.
- 14)Is pregnant or expecting to conceive, is breastfeeding, or plans to breastfeed from the time of consent through at least 90 days following cessation of study therapy.
- 15)Has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or put the participant at undue risk, as judged by the investigator, such that it is not in the best interest of the participant to participate in this study.
- 16)laboratory value at screening: hemoglobin <8g/dL; Or neutrophils <1.0109/L; Or platelet <25109/L; Serum AST or ALT>5×ULN; Or serum total bilirubin >2.5×ULN; 17)Has received within 30 days prior to randomization or plans to receive during the study any of the following anti-CMV IgG antibody treatment or anti-CMV drug therapy including: Cidofovirb. CMV hyper-immune globulinc. Any investigational CMV antiviral agent/biologic therapy.
- 18)Has received within 7 days prior to randomization or plans to receive during the study any of the following anti-CMV drug therapy including: LET, GCV, VGCV, Foscarneth, ACV (at doses >3200 mg PO per day or >25 mg/kg IV per day), Valacyclovir (at doses >3 g PO per day), Famciclovir (at doses >1500 mg PO per day).
- 19)are expected to receive TCM or herbal treatment during study treatment and within 14 days after study administration; 20)Is currently participating or has participated in a study with an unapproved investigational compound or device within 28 days, or 5 x half-life of the investigational compound (excluding monoclonal antibodies), whichever is longer, of initial dosing on this study. Participants previously treated with an investigational monoclonal antibody will be eligible to participate after a 150-day washout period.
- 21)Has previously participated or is currently participating in any study involving administration of a CMV vaccine or another CMV investigational agent, or is planning to participate in a study of a CMV vaccine or another CMV investigational agent during the course of this study.
- 22)Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling or child) who is investigational site or sponsor staff directly involved with this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, 710000
Xiaoming Xiaoming Ding, +86 13991238632, xmding1970@163.com
1142899697@qq.com
About this study
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.
Read the detailed description
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
- Kidney Transplant
- Being tested
- Letermovir, Valganciclovir
- Keywords
- Kidney Transplant, cytomegalovirus, letemovir, valganciclovir, Randomized control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LetermovirDrug
Drug name: Letermovir.
ValganciclovirDrug
Valganciclovir.
| Study group | Role | What they receive |
|---|---|---|
| Valganciclovir | Experimental | 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. Receives: Drug: Valganciclovir |
| Letermovir | Active comparator | 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. Receives: Drug: Letermovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CMV disease at 52 weeks after transplantation
Proportion of subjects diagnosed with CMV disease at week 52 after transplantation.
Measured: 52 weeks after transplantation
Secondary outcomes (4)
Incidence of CMV disease at 14/24 weeks after transplantation
Proportion of subjects diagnosed with CMV disease at week 14/26 after transplantation.
Measured: 14/24 weeks after transplantion
Time of CMV onset 52 weeks after transplantation
From the day of transplant to the first diagnosis of CMV disease.
Measured: 52 weeks after transplantation
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.
Measured: 14/24/52 weeks after transplantion
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.
Measured: 52 weeks after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start13 May 2025
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07266467
- Sponsor's protocol ID
- XJTUAF2025-CAPS01
- Acronym
- CAPS01
- Status last verified
- Mar 2025
- First submitted
- 11 May 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Publish the statistical results after the completion of the experiment in the form of academic papers
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Leymovir Versus Valganciclovir in Prevention of Cytomegalovirus Infection and Cytomegalovirus Disease in Chinese Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT07266467
- Acronym / sponsor ID
- CAPS01 / XJTUAF2025-CAPS01
- Conditions
- Kidney Transplant
- Keywords
- Kidney Transplant, cytomegalovirus, letemovir, valganciclovir, Randomized control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- 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
- Study start
- 13 May 2025 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Valganciclovir | Experimental | Drug: ValganciclovirExperimental 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. |
| Letermovir | Active comparator | Drug: LetermovirDrug 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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 .
Key exclusion criteria (17 listed)
- 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 calculated using the Cockcroft-Gault equation using the most recently obtained and available serum creatinine value collected within 3 calendar days prior to and including the day of randomization and after the conclusion of any clinically warranted (at the discretion of the investigator) post-transplant dialysis or plasmapheresis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LetermovirDrug name: Letermovir. | Drug | Letermovir |
| ValganciclovirValganciclovir. | Drug | Valganciclovir |
Primary outcome
Incidence of CMV disease at 52 weeks after transplantation
Time frame: 52 weeks after transplantation
Proportion of subjects diagnosed with CMV disease at week 52 after transplantation.
4 secondary outcomes
Incidence of CMV disease at 14/24 weeks after transplantation
Time frame: 14/24 weeks after transplantion
Time of CMV onset 52 weeks after transplantation
Time frame: 52 weeks after transplantation
Incidence of CMV DNaemia at 14/26/52 weeks after transplantation
Time frame: 14/24/52 weeks after transplantion
Incidence and severity of all adverse events
Time frame: 52 weeks after transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2025.
- Individual participant dataSharing planned: No. Publish the statistical results after the completion of the experiment in the form of academic papers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Letermovir and Valganciclovir in people with Kidney Transplant, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoming Ding (+86 13991238632, xmding1970@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CMV disease at 52 weeks after transplantation (time frame: 52 weeks after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2025.