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Study on Preventing CMV Infection in Low-Risk Kidney Transplant Patients Using Ganciclovir and Valganciclovir

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the prevention of cytomegalovirus (CMV) infection in patients who have received a kidney transplant and are considered low-risk. The study will use two medications: Ganciclovir and Valganciclovir. Ganciclovir is administered as a solution for infusion, which means it is given directly into the bloodstream through a vein. Valganciclovir is taken as a film-coated tablet, which is a type of pill that is swallowed.

The purpose of the study is to compare two different approaches to preventing CMV infection in kidney transplant recipients. One approach is called immune-guided prophylaxis, which involves using the body's immune response to guide treatment. The other approach is preemptive therapy, which means starting treatment as soon as early signs of infection appear. The study will monitor the effectiveness and safety of these approaches over time.

Participants in the study will be observed for up to 12 months after their kidney transplant. The study will look at how many patients develop CMV disease and how many experience a condition called neutropenia, which is a low level of a type of white blood cell that helps fight infections. The study will also track the number of days patients take Valganciclovir and any side effects that occur. The goal is to determine which approach provides better outcomes for patients, with a focus on preventing CMV disease without causing neutropenia.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed. Participants must be over 18 years old, have received a kidney transplant, and be CMV-seropositive. Non-menopausal women must have a negative pregnancy test.

  2. Step 2

    Initial treatment phase

    Participants receive treatment to prevent CMV infection. This involves taking valganciclovir in the form of a film-coated tablet. The dosage and frequency are determined by the study team based on individual needs.

  3. Step 3

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor health and the effectiveness of the treatment. Blood tests are conducted to check for CMV infection and to monitor for any side effects, such as neutropenia, which is a low level of white blood cells.

  4. Step 4

    Evaluation at 6 months

    At 6 months post-transplant, the study evaluates the proportion of participants with CMV disease and any degrees of neutropenia. The safety of the treatment is assessed by the number of days participants have taken valganciclovir and the occurrence of any adverse events.

  5. Step 5

    Evaluation at 12 months

    At 12 months post-transplant, a final evaluation is conducted. The study measures the incidence of CMV disease and the safety of the treatment, focusing on the presence of neutropenia. The results are ranked using a method called DOOR, which assesses the desirability of outcomes.

Who can join the trial?

3 criteria

  • Must be over 18 years of age.
  • Must be a CMV-seropositive kidney transplant recipient. CMV-seropositive means that you have been exposed to the cytomegalovirus (CMV) in the past and have developed antibodies against it.
  • For women who are not menopausal, a negative pregnancy test is required.

Who cannot join the trial?

3 criteria

  • Patients who are not considered low-risk for kidney transplant.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a vulnerable population group.
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Investigated drugs

INMUNOVIR is a medication being studied for its potential to help prevent infections in people who have received a kidney transplant. After a kidney transplant, patients are at risk of infections because their immune system is weakened. This medication is being tested to see if it can help guide the immune system to prevent a specific type of infection called CMV, which is common in transplant patients. The study is looking at how well this medication works and how safe it is for patients to use.

What is already known about the treatment

INMUNOVIR – INMUNOVIR is administered orally in the form of tablets and is currently being studied for its effectiveness and safety in preventing CMV infection in low-risk kidney transplant patients. This medication is in the clinical trial phase, focusing on immune-guided prophylaxis compared to preemptive therapy. It is primarily indicated for use in kidney transplant recipients to prevent viral infections. At the molecular level, INMUNOVIR works by enhancing the body's immune response to fight off infections. It is classified pharmacologically as an immunomodulator, which means it helps regulate the immune system to better protect against diseases.

Investigated diseases

  • Cytomegalovirus Disease

    Cytomegalovirus (CMV) disease is caused by the CMV virus, which is a type of herpesvirus. It can remain dormant in the body and reactivate, especially in individuals with weakened immune systems, such as organ transplant recipients. The disease often begins with flu-like symptoms, including fever, fatigue, and muscle aches. As it progresses, it can affect various organs, leading to complications such as pneumonia, hepatitis, or gastrointestinal issues. In severe cases, it may cause inflammation of the retina, leading to vision problems. The progression and severity of symptoms can vary widely among individuals.

  • Neutropenia

    Neutropenia is a condition characterized by an abnormally low number of neutrophils, a type of white blood cell essential for fighting off infections. It can result from various factors, including certain medications, medical treatments, or underlying health conditions. As neutropenia progresses, individuals become more susceptible to infections, which can manifest as frequent or severe bacterial infections. Symptoms may include fever, mouth ulcers, and skin infections. The severity of neutropenia is often classified based on the neutrophil count, with lower counts indicating a higher risk of infection. The condition requires careful monitoring to prevent complications.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-520742-29-00Protocol codeFCO-INM-2024-01Estimated enrolment170 patientsSponsorFundacion Para La Investigacion Biomedica De Cordoba

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