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Study on Pioglitazone for Improving Kidney Health in Patients with ANCA-Associated Vasculitis

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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 a condition called ANCA-associated vasculitis, which is a type of inflammation of the blood vessels. The study aims to evaluate the effectiveness of a medication called pioglitazone in improving kidney health in patients with this condition. Pioglitazone will be used in addition to the standard treatment, which includes medications like glucocorticoids and rituximab. Glucocorticoids are a type of steroid used to reduce inflammation, and rituximab is a medication that helps control the immune system.

The purpose of the study is to see if adding pioglitazone to the usual treatment can help reduce kidney damage in patients with ANCA-associated vasculitis. The study will last for about six months, during which participants will receive the treatment and have regular check-ups to monitor their kidney function and overall health. The study will also look at how the treatment affects the quality of life and any side effects that may occur.

Participants in the study will receive either pioglitazone or a placebo, which is a substance with no active medication, along with their standard treatment. The study will involve regular visits to the clinic for assessments and to ensure the safety and effectiveness of the treatment. The goal is to find out if pioglitazone can provide additional benefits in managing ANCA-associated vasculitis and improving kidney outcomes.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes reviewing medical history and conducting necessary tests to ensure the presence of ANCA-associated vasculitis.

    A recent renal biopsy confirming renal involvement is required. Blood and urine tests will be performed to check for proteinuria and other markers.

  2. Step 2

    Consent and enrollment

    You will be asked to provide written informed consent to participate in the study. This ensures that you understand the trial's purpose and procedures.

    Once consent is given, you will be officially enrolled in the study.

  3. Step 3

    Treatment initiation

    The treatment phase begins with the administration of the standard care regimen, which includes glucocorticoids and rituximab. These medications are given to manage vasculitis symptoms.

    You will also receive pioglitazone as an add-on treatment. This medication is taken orally in the form of Actos 30 mg tablets.

  4. Step 4

    Treatment schedule

    The pioglitazone tablets are to be taken daily for a duration of six months. The exact dosage and frequency will be provided by the study team.

    Regular monitoring will occur throughout the treatment period to assess the effectiveness and safety of the medications.

  5. Step 5

    Follow-up visits

    Follow-up visits are scheduled at weeks 4, 12, 26, and 52. During these visits, your renal function and overall health will be evaluated.

    Tests will include blood and urine analysis to measure protein levels and kidney function, as well as assessments of any side effects from the medications.

  6. Step 6

    End of treatment evaluation

    At the end of the six-month treatment period, a comprehensive evaluation will be conducted to determine the impact of the treatment on your renal health.

    The primary goal is to observe improvements in kidney function and a reduction in proteinuria.

  7. Step 7

    Long-term follow-up

    After the treatment phase, long-term follow-up will continue until week 52 to monitor your health and any lasting effects of the treatment.

    This includes regular assessments of kidney function, quality of life, and any potential side effects.

Who can join the trial?

6 criteria

  • Must have a new diagnosis or a relapse of ANCA-associated vasculitis, which includes conditions like granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA). This should be confirmed by specific medical criteria and an active disease score of 3 or more.
  • Must have proteinuria (high levels of protein in urine), haematuria (blood in urine), and an estimated glomerular filtration rate (eGFR) of at least 15 mL/min/1.73 m², which is a measure of kidney function.
  • Must have had a recent kidney biopsy (within the last 4 weeks) that shows kidney involvement due to ANCA-associated vasculitis.
  • Must be between 18 and 80 years old.
  • Must provide written informed consent to participate in the study.
  • Must be affiliated with a French health insurance system, either as a registered member or as a beneficiary.

Who cannot join the trial?

8 criteria

  • Patients who are not diagnosed with ANCA-associated vasculitis cannot participate.
  • Patients who are not within the specified age range cannot participate.
  • Patients who are part of a vulnerable population cannot participate.
  • Patients who are not able to follow the study procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have a history of allergic reactions to the study medication cannot participate.
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Investigated drugs

  • Pioglitazone

    is a medication that is being tested to see if it can help protect the kidneys in people with a condition called ANCA-associated vasculitis. This condition can cause damage to the kidneys, and the trial is looking at whether adding pioglitazone to the usual treatment can reduce this damage. Pioglitazone is usually used to help control blood sugar levels in people with diabetes, but in this trial, it is being used to see if it can also help improve kidney function.

  • Glucocorticoids

    are a type of medication that helps reduce inflammation in the body. In this trial, they are part of the standard treatment for ANCA-associated vasculitis. These medications work by calming down the immune system, which can help prevent further damage to the kidneys caused by the disease.

  • Rituximab

    is a medication that is used to treat certain autoimmune diseases, including ANCA-associated vasculitis. It works by targeting specific cells in the immune system that are involved in causing inflammation and damage. In this trial, rituximab is part of the standard treatment plan, and researchers are studying how well it works alongside pioglitazone and glucocorticoids to protect the kidneys.

What is already known about the treatment

Pioglitazone – Pioglitazone is taken orally in the form of a tablet and is currently being studied for its potential benefits in treating ANCA-associated vasculitis, a condition that causes inflammation of blood vessels. This medication is being evaluated in clinical trials to see if it can help reduce kidney damage when used alongside standard treatments like glucocorticoids and rituximab. Pioglitazone works by activating a specific protein in the body that helps regulate glucose and fat metabolism, which may also have anti-inflammatory effects. It is classified as a thiazolidinedione, a type of drug commonly used to manage blood sugar levels in diabetes.

Investigated diseases

ANCA-associated vasculitis – ANCA-associated vasculitis is a group of diseases characterized by inflammation of small to medium-sized blood vessels, often affecting the kidneys, lungs, and other organs. The disease is associated with the presence of anti-neutrophil cytoplasmic antibodies (ANCA) in the blood. It typically begins with symptoms such as fatigue, fever, and weight loss, followed by more specific signs depending on the organs involved. As the disease progresses, it can lead to organ damage, particularly in the kidneys, causing issues like proteinuria and elevated serum creatinine levels. The inflammation can also cause damage to the respiratory system, leading to symptoms like coughing and shortness of breath. Over time, the disease can result in chronic damage to affected organs if not managed properly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501057-36-00Protocol codeAPHP211045Estimated enrolment126 patientsSponsorAssistance Publique Hopitaux De Paris

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