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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

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

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
03.07.2023

Trial locations

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.

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 ID:
2023-503226-39-00
Protocol code:
22-AOIP-03
Trial Phase:
Therapeutic exploratory (Phase II)

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