Study on Preventing Cytomegalovirus Infection Using Valganciclovir in Kidney Transplant Patients

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What is this study about?

This clinical trial is focused on studying the effectiveness of a new preventive strategy for managing cytomegalovirus (CMV) infection in patients who have received a kidney transplant. CMV is a common virus that can cause serious health issues in people with weakened immune systems, such as those who have undergone organ transplants. The study will compare two different approaches to preventing CMV infection: a new strategy that is guided by the patient’s immune response and the standard universal preventive approach.

The treatment being tested in this study is called Valganciclovir, which is a medication used to prevent CMV infections. Participants in the study will receive this medication in the form of a film-coated tablet. The study will last for a period of six months following the kidney transplant, during which the effectiveness of the new preventive strategy will be evaluated. Some participants will receive the new strategy, while others will follow the standard preventive approach, and some may receive a placebo.

The main goal of the study is to determine how well the new strategy works in preventing CMV infections compared to the standard approach. Researchers will monitor the participants for any signs of CMV infection and will also assess the need for additional antiviral treatments. The study aims to provide valuable insights into improving the care and outcomes for kidney transplant patients at risk of CMV infection.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, recent kidney transplant status, and CMV seropositivity.

Participants must have undergone a kidney transplant within 1 to 12 days prior to joining and must be CMV positive, as determined by a specific blood test.

2 initial treatment phase

Participants receive a non-depleting immunosuppressive treatment called Basiliximab before the transplant.

This treatment is part of the standard care to prevent the body from rejecting the new kidney.

3 medication administration

Participants are administered valganciclovir, a medication used to prevent CMV infection.

The medication is provided in the form of a 450 mg film-coated tablet, taken orally.

4 monitoring period

Participants are monitored for CMV infection over a period of 6 months following the kidney transplant.

Regular assessments are conducted to measure the presence of CMV in the blood and the number of CMV-specific T lymphocytes at specific intervals, such as 15 weeks and 28 weeks post-transplant.

5 evaluation of outcomes

The primary outcome measured is the proportion of participants who develop CMV infection within 6 months of transplantation.

Secondary outcomes include the need for additional antiviral treatment and the development of CMV disease within the same timeframe.

6 completion of study

The study is expected to conclude by March 28, 2026, with the recruitment phase starting on March 28, 2024.

Final evaluations will include cost-effectiveness analysis and overall effectiveness of the preventive strategy compared to standard care.

Who Can Join the Study?

Age between 18 and 75 years old.
Received a kidney transplant between 1 to 12 days ago.
Tested positive for CMV (Cytomegalovirus) on the day of the transplant. This means having a specific level of antibodies in the blood.
Receiving a specific type of medication to prevent the immune system from attacking the new kidney, called non-depleting inducing immunosuppressive treatment (Basiliximab), given before the transplant.
Must be part of a social security scheme.
Must have read, understood, and signed an information letter about the study.
For women who can have children: Must use effective birth control methods, such as birth control pills, an intrauterine device, or have had a tubal ligation, for at least 1 month before joining the study and continue during the study and for at least 30 days after stopping the study treatment. Must also have a negative pregnancy test before joining the study.
For women who are postmenopausal: Must have had no menstrual periods for at least 12 months before joining the study.
For women who are surgically sterile: Must have had surgery to remove the ovaries and/or uterus.
For men: Must have had surgery to become sterile, or use a condom during the study and for at least 90 days after stopping the study treatment, or have a partner who uses effective birth control methods, or have a partner who is postmenopausal or surgically sterile.

Who Cannot Join the Study?

Patients who are not positive for CMV. CMV stands for Cytomegalovirus, a common virus that can affect people with weakened immune systems.
Patients who have not undergone a kidney transplant.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not considered part of a vulnerable population. A vulnerable population includes individuals who may have a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Lille	Lille	France

Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire Rouen	Rouen	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	28.03.2024

Trial locations

Investigated drugs:

Valganciclovir

Valganciclovir is a medication used to prevent cytomegalovirus (CMV) infection in patients who have received a kidney transplant. It works by stopping the virus from multiplying in the body, which helps to prevent the infection from developing or spreading.

Ganciclovir is another medication that helps prevent CMV infection in kidney transplant patients. Similar to valganciclovir, it inhibits the growth of the virus, reducing the risk of infection after transplantation.

Immuno-guided therapy is a strategy used to tailor the prevention of CMV infection based on the patient’s immune response. This approach aims to provide a more personalized treatment plan, potentially reducing the need for medication and minimizing side effects.

Cytomegalovirus Infection – Cytomegalovirus (CMV) infection is caused by a common virus that can infect people of all ages. Once the virus is in a person’s body, it stays there for life and can reactivate. In healthy individuals, CMV usually causes mild symptoms or none at all. However, in people with weakened immune systems, such as transplant patients, it can lead to more serious illness. The virus can affect various parts of the body, including the eyes, lungs, liver, and digestive system. CMV infection can be particularly concerning in transplant patients, as it may lead to complications and affect the success of the transplant.

Trial ID:

2024-515925-27-00

Protocol code:

2020/0422/HP

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Preventing Cytomegalovirus Infection Using Valganciclovir in Kidney Transplant Patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?