Study on Letermovir and Valganciclovir for Treating CMV Infections in Kidney Transplant Patients

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What is this study about?

This clinical trial is focused on studying the treatment of cytomegalovirus (CMV) infections in individuals who have received a kidney transplant. The study will compare two treatment approaches: a combination of two medications, letermovir and valganciclovir, versus using valganciclovir alone. Letermovir is available in the form of film-coated tablets known as PREVYMIS. The purpose of the study is to determine if the combination of these two medications is more effective in treating CMV infections in kidney transplant recipients than using valganciclovir by itself.

Participants in the study will receive either the combination of letermovir and valganciclovir or valganciclovir alone. Some participants may receive a placebo, which looks like the medication but does not contain the active ingredient. The study will last for a period of up to 12 weeks, during which participants will have regular check-ups to monitor their health and the effectiveness of the treatment. The main goal is to see if the combination treatment can reduce the amount of CMV in the blood by the third week of treatment.

Throughout the study, participants will be closely monitored for any side effects and changes in their health. Regular blood tests will be conducted to measure the levels of CMV and to ensure the safety and effectiveness of the treatment. The study aims to provide valuable information on the best treatment approach for managing CMV infections in kidney transplant patients, potentially improving outcomes for those affected by this condition.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, weight, kidney transplant status, and the presence of a cytomegalovirus (CMV) infection with specific DNA levels.

A blood test is performed to measure CMV DNA levels, ensuring they meet the required threshold for participation.

2 randomization and treatment assignment

Participants are randomly assigned to one of two treatment groups: a combination of letermovir and valganciclovir, or valganciclovir alone.

The combination group receives PREVYMIS 240 mg film-coated tablets (letermovir) and valganciclovir tablets, both taken orally.

3 treatment administration

Participants take the assigned medication orally as per the study protocol. The exact dosage and frequency are determined by the study team based on individual needs and group assignment.

The treatment continues for a specified duration, with regular monitoring to assess the response.

4 weekly monitoring

Weekly visits are scheduled to monitor CMV DNA levels in the blood, assess any side effects, and ensure adherence to the medication regimen.

Blood tests are conducted to check for CMV DNA levels, and other health indicators such as neutrophil count, liver enzymes, and kidney function.

5 week-3 evaluation

At Week-3, a key evaluation is performed to determine the virological response. This involves checking for a significant decrease in CMV DNA levels or achieving undetectable levels.

Additional tests may include sequencing of specific genes related to CMV and measuring the concentration of the medications in the blood.

6 continued monitoring and final assessment

Monitoring continues up to Week-12, with regular assessments of CMV DNA levels and overall health.

A final assessment is conducted to evaluate the eradication of CMV DNA and the absence of CMV-related symptoms.

Who Can Join the Study?

Must be 18 years or older.
Must provide informed consent and sign it. This means you understand the study and agree to participate.
Must weigh 30 kg or more.
Must have had a kidney transplant.
Must have a documented CMV infection. This means having a certain level of CMV in your blood, confirmed by two tests at least one day apart, done within 14 days before starting the study.
Must be eligible for treatment with oral valganciclovir, as decided by the doctor.
If you are of childbearing age, you must have a negative pregnancy test and use an effective method of contraception until 30 days after the study ends. For men, an effective method of contraception is needed until 90 days after the study ends.
Must have a life expectancy of at least 8 weeks.
Must be French speaking.
Must be affiliated with a social security system or an equivalent system.

Who Cannot Join the Study?

Patients who have had a kidney transplant cannot participate. A kidney transplant is a surgery to place a healthy kidney from a donor into a person whose kidneys no longer function properly.
Patients with CytoMegaloVirus (CMV) infections are excluded. CMV is a common virus that can cause disease in people with weakened immune systems, such as those who have had a transplant.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire Rouen	Rouen	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.12.2023

Trial locations

Investigated drugs:

Letermovir is a medication used in this trial to help treat cytomegalovirus (CMV) infections in kidney transplant recipients. It works by stopping the virus from multiplying, which can help control the infection and prevent it from causing harm to the body.

Valganciclovir is another medication used in this trial, both on its own and in combination with letermovir. It is an antiviral drug that helps to treat CMV infections by reducing the amount of virus in the body, which can help improve symptoms and prevent complications.

Investigated diseases:

Cytomegalovirus infection

Kidney Transplant – A kidney transplant is a surgical procedure where a healthy kidney from a donor is placed into a person whose kidneys no longer function properly. This condition arises when the kidneys are unable to filter waste from the blood effectively, leading to a buildup of harmful substances. The transplanted kidney takes over the function of filtering blood, allowing the recipient to lead a more normal life. Over time, the body may attempt to reject the new kidney, which requires careful monitoring and medication to prevent. The success of the transplant depends on various factors, including the match between donor and recipient and the recipient’s overall health.

Cytomegalovirus Infections – Cytomegalovirus (CMV) infections are caused by a common virus that can infect people of all ages. Once infected, the virus remains in the body for life and can reactivate, especially in individuals with weakened immune systems. In healthy individuals, CMV may cause mild symptoms or none at all, but in those with compromised immunity, it can lead to more serious health issues. The virus can affect various parts of the body, including the eyes, lungs, liver, and digestive tract. CMV is particularly concerning for organ transplant recipients, as it can complicate recovery and affect the success of the transplant.

Trial ID:

2023-506216-40-00

Protocol code:

APHP220791

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Letermovir and Valganciclovir for Treating CMV Infections in Kidney Transplant Patients

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