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Study of Peginterferon Alfa-2a for Patients with Extramembranous Glomerulonephritis

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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 effects of a treatment for a kidney condition known as extramembranous glomerulonephritis. This condition involves inflammation of the tiny filters in the kidneys, which can lead to kidney damage. The treatment being tested is called Pegasys, which is a form of medication known as peginterferon alfa-2a. It is administered as a solution for injection using a pre-filled syringe.

The purpose of the study is to observe the immune system's activity in patients with this kidney condition who have experienced a return of symptoms. The study will involve a personalized approach to therapy, focusing on a specific part of the immune system known as the Th17 pathway. Patients will receive the Pegasys treatment over a period of six months. During this time, researchers will monitor changes in certain antibodies and proteins in the blood, which are indicators of the body's immune response.

Participants in the study will receive regular injections of Pegasys and will have their blood tested to measure levels of specific antibodies and proteins. The study aims to determine how the treatment affects these levels and to assess the overall tolerance of the therapy. The goal is to find an effective treatment regimen that can help manage the condition by reducing certain immune system markers.

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, you will be informed about the purpose and procedures involved. This study aims to measure the activity of your immune system after receiving a personalized therapy.

    You will be asked to provide consent to participate in the study, ensuring you understand the potential risks and benefits.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes checking your age, medical history, and specific blood test results.

    Your blood will be tested for certain antibodies and immune cell activity to ensure you meet the study criteria.

  3. Step 3

    Treatment phase

    You will receive a medication called peginterferon alfa-2a (Pegasys) through a subcutaneous injection, which means it is injected under the skin.

    The dosage is 180 micrograms, and it will be administered once a month for a duration of six months.

  4. Step 4

    Monitoring and follow-up

    Throughout the treatment phase, regular follow-up visits will be scheduled to monitor your health and the effects of the medication.

    Blood tests will be conducted to measure changes in antibody levels, protein levels in urine, and various immune system markers.

  5. Step 5

    Final assessment

    At the end of the six-month treatment period, a final assessment will be conducted to evaluate the overall impact of the therapy.

    This will include a comprehensive review of your health status and any changes in your immune system activity.

Who can join the trial?

8 criteria

  • Participants must be 18 years or older.
  • Participants must have GEM with anti-PLA2R1 autoantibody. This means they have a specific type of antibody in their blood.
  • Participants must have experienced an immunological relapse. This is defined as an increase in anti-PLA2R1 antibody levels greater than 14 RU/mL after a period when these antibodies were not present.
  • Participants must have IL-17A plasma levels greater than 73 pg/mL. This is a measure of a specific protein in the blood after the immune cells are stimulated.
  • Participants must be on symptomatic antiprotein treatment with a stable and maximum tolerated dosage. This means they are receiving treatment to manage symptoms related to protein levels in the body.
  • Participants must have a biological workup at the screening visit that includes:
    • A platelet count of at least 90,000 cells/mm3. Platelets are cells that help with blood clotting.
    • A neutrophil count of at least 1,500 cells/mm3. Neutrophils are a type of white blood cell important for fighting infections.
    • Normal thyroid function that is appropriately monitored. This involves checking levels of TSH and T4, which are hormones related to thyroid function.

Who cannot join the trial?

5 criteria

  • Patients with **extramembranous glomerulonephritis** cannot participate. This is a kidney condition where the filters in the kidneys are damaged.
  • Patients who do not have a **Th17-like cytokine profile** are excluded. Cytokines are proteins that help cells communicate in the immune system, and Th17 is a specific type of these proteins.
  • Patients who are not experiencing an **immunological relapse** are excluded. An immunological relapse means the immune system is reacting again after a period of improvement.
  • Patients who are not between the ages of 18 and 65 cannot participate.
  • Patients who are part of a **vulnerable population** are excluded. This means groups of people who might need special protection, like children or those unable to make decisions for themselves.
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Investigated drugs

Pegasys® is a medication used in this clinical trial. It is a form of interferon, which is a protein that helps the immune system fight infections and other diseases. In this study, Pegasys® is being used to help regulate the immune system in patients with a specific type of kidney disease called extramembranous glomerulonephritis. The goal is to see if Pegasys® can help control the immune response in these patients, especially those who have a certain immune profile related to the Th17 pathway.

What is already known about the treatment

Pegasys® – Pegasys® is administered as an injection under the skin, typically in the abdomen or thigh. It is currently being studied for its effects on the immune system in patients with extramembranous glomerulonephritis, a kidney condition. The main therapeutic use of Pegasys® in this study is to regulate immune responses, particularly those involving Th17 cells, which are a type of immune cell. At the molecular level, Pegasys® works by interacting with specific proteins in the body to modulate immune activity, helping to reduce inflammation and immune system overactivity. It is classified as an immunomodulatory medication, which means it helps adjust the immune system's function.

Investigated diseases

Extramembranous glomerulonephritis – This disease is a kidney disorder characterized by inflammation and thickening of the membranes within the glomeruli, which are tiny structures in the kidneys that filter waste from the blood. It often begins with the immune system mistakenly attacking the kidney membranes, leading to damage. As the condition progresses, protein may leak into the urine, a condition known as proteinuria. Over time, this can result in swelling in various parts of the body due to fluid retention. The disease can cause changes in blood pressure and kidney function. It is a chronic condition that can vary in severity and progression among individuals.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503226-39-00Protocol code22-AOIP-03Estimated enrolment5 patientsSponsorCentre Hospitalier Universitaire De Nice

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).