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Study on Continuing or Stopping Immunosuppressive Therapy with Rituximab in Patients with ANCA Vasculitis and End-stage Kidney Disease

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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 two diseases: ANCA vasculitis and end-stage renal disease. ANCA vasculitis is a condition where the immune system attacks the blood vessels, leading to inflammation. End-stage renal disease is the final stage of chronic kidney disease, where the kidneys can no longer function properly. The study is investigating the effects of stopping or continuing immunosuppressive therapy in patients with these conditions. Immunosuppressive therapy involves medications that reduce the activity of the immune system to prevent it from attacking the body.

The medications being studied include rituximab, azathioprine, prednisone, and mycophenolate mofetil. Rituximab is given as an injectable solution, while azathioprine, prednisone, and mycophenolate mofetil are taken orally in tablet form. The purpose of the study is to determine if stopping immunosuppressive therapy is better for patients with end-stage renal disease and ANCA vasculitis compared to continuing the standard maintenance therapy. The study will follow participants for 24 months to observe any severe events such as major relapses, severe infections, or death.

Participants in the study will be randomly assigned to either continue their current immunosuppressive therapy or to stop it. The study will monitor the health of the participants over the course of two years to see which approach leads to better outcomes. This research aims to provide valuable information on the best treatment approach for patients with these serious conditions.

The research process

The trial runs in 4 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, the patient is randomly assigned to one of two groups: one group will continue with standard maintenance immunosuppressive therapy, and the other group will discontinue immunosuppressive therapy.

  2. Step 2

    Medication administration

    For patients continuing therapy, medications may include rituximab (injectable solution), azathioprine (oral tablet), prednisolone (oral tablet), mycophenolate mofetil (oral film-coated tablet), and prednisone (oral tablet).

    The specific dosage and frequency of these medications will be determined by the study protocol and the patient's medical condition.

  3. Step 3

    Monitoring and follow-up

    Patients will be monitored regularly to assess their health status and any potential side effects of the treatment.

    The primary focus is on the time between randomization and the first severe event, such as a severe infection, major relapse of ANCA vasculitis, or death, over a 24-month follow-up period.

  4. Step 4

    Evaluation of outcomes

    The study aims to evaluate the effectiveness of discontinuing immunosuppressive therapy compared to continuing standard therapy in terms of severe event-free survival over 24 months.

Who can join the trial?

7 criteria

  • Age between 18 and 90 years old.
  • Patients with a condition called **GPA** or **MPA AAV**, which involves kidney damage.
  • Patients experiencing their first symptoms or a return of **AAV**.
  • Patients with **End-stage Renal Disease (ESRD)**, which means their kidneys are not working well. This is defined by a specific test result (glomerular filtration rate) of 15 or less, or if they need dialysis for more than 60 days.
  • Patients with **ESRD** in their original kidneys, not transplanted ones.
  • Patients who have agreed in writing to participate in the study.
  • Patients who are part of the French social security system.

Who cannot join the trial?

2 criteria

  • Patients with end-stage renal disease, which means the kidneys are no longer working well enough to meet the body's needs.
  • Patients with ANCA vasculitis, a condition where the immune system attacks small blood vessels, causing inflammation.
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Investigated drugs

Immunosuppressive Therapy is a treatment used to reduce the activity of the immune system. In this clinical trial, it is used as a standard maintenance therapy for patients with ANCA vasculitis and end-stage renal disease. The goal is to prevent the immune system from attacking the body's own tissues, which can help manage the symptoms of the disease and prevent further damage to the kidneys.

What is already known about the treatment

Prednisone – Prednisone is typically administered orally in the form of tablets. It is a well-established medication in medical literature, commonly used for its anti-inflammatory and immunosuppressive properties. The main therapeutic indications for prednisone include conditions like ANCA vasculitis and other autoimmune disorders. At the molecular level, prednisone works by suppressing the immune system and reducing inflammation by inhibiting the production of substances that trigger inflammatory and immune responses. It is classified as a corticosteroid.

Investigated diseases

  • End-stage Renal Disease

    This condition occurs when the kidneys are no longer able to function at a level needed for day-to-day life. It is the final stage of chronic kidney disease, where the kidneys have lost about 90% of their ability to function normally. Patients with this disease often require dialysis or a kidney transplant to survive. The progression involves a gradual decline in kidney function over time, leading to the accumulation of waste products in the body. Symptoms may include fatigue, swelling, and difficulty concentrating. The disease can result from various causes, including diabetes and high blood pressure.

  • ANCA Vasculitis

    This is an autoimmune disease characterized by inflammation of the blood vessels, which can lead to damage in various organs. The condition is associated with the presence of anti-neutrophil cytoplasmic antibodies (ANCA) in the blood. It can affect small to medium-sized blood vessels, leading to symptoms such as fatigue, fever, and weight loss. As the disease progresses, it can cause organ damage, particularly in the kidneys and lungs. The inflammation can lead to reduced blood flow and tissue damage. The exact cause of ANCA vasculitis is not well understood, but it involves an abnormal immune response.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-512470-10-00Protocol codeCHD005-17Estimated enrolment136 patientsSponsorCentre Hospitalier Departemental Vendee

sourced from the EU Clinical Trials Register and site verification

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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).