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Testing avacopan added to standard treatment in patients with ANCA-associated vasculitis with severe kidney damage

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What is this trial about?

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

This study involves ANCA-associated vasculitis, a condition where the body's immune system attacks its own blood vessels, leading to inflammation and damage. When this disease affects the kidneys severely, it can cause rapid kidney function decline. The study will test whether adding a medication called AMG 569, which contains avacopan, to the standard treatment can help improve kidney function in patients with severe kidney involvement. Participants will receive either AMG 569 or placebo in addition to their regular treatment. The standard treatment includes medications such as rituximab or cyclophosphamide combined with steroid medications like methylprednisolone, prednisone, or prednisolone. Some patients may also receive plasma exchanges, a procedure that removes and replaces blood plasma, as part of their care.

The main goal of this study is to find out if adding AMG 569 to standard treatment can help more patients achieve better kidney function after one year of treatment compared to those receiving placebo with standard treatment. Better kidney function is defined as reaching a specific level of kidney filtering ability that indicates less severe kidney disease. The study will also look at other important outcomes such as survival rates, disease activity and damage scores, how many patients achieve complete disease remission, changes in kidney function over time, protein levels in urine, how many patients need long-term dialysis, and quality of life measures. Additionally, researchers will measure various substances in blood and urine that indicate inflammation and immune system activity, and will examine kidney tissue samples to assess the degree of kidney damage.

Patients participating in this study will be followed for approximately one year and three months. During this time, they will have regular visits where their kidney function will be checked through blood and urine tests, and their overall disease activity will be assessed. The study requires a kidney biopsy, which is a procedure where a small piece of kidney tissue is removed for examination, either before joining the study or within the first month of participation. Participants will continue to receive their standard treatment for the disease while also taking either AMG 569 or placebo. The study will monitor for any side effects or complications, including infections, diabetes, liver problems, and other adverse events that may occur during the treatment period.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    At the start of the trial, your treatment will begin with standard therapy for your condition. This includes receiving either rituximab or cyclophosphamide combined with glucocorticoids (steroid medications that reduce inflammation). In some cases, plasma exchanges may also be included.

    You will receive either avacopan or a placebo (an inactive substance) in addition to the standard therapy. The placebo looks identical to avacopan but contains no active medication. Neither you nor your doctor will know which one you are receiving during the trial.

    Avacopan is taken orally (by mouth).

    If rituximab is part of your treatment, it will be given through infusion (a slow injection into a vein).

    If cyclophosphamide is part of your treatment, it will be taken orally.

    The glucocorticoid medications (prednisone, prednisolone, or methylprednisolone) will be taken orally.

    Your standard therapy may have started up to 2 weeks before joining this trial.

  2. Step 2

    Kidney biopsy

    A kidney biopsy (a procedure where a small sample of kidney tissue is removed for examination) must be available. This biopsy should have been performed up to 6 weeks before joining the trial.

    If a recent kidney biopsy is not available, the procedure will be performed no later than the visit at week 4.

  3. Step 3

    Week 4 evaluation

    At week 4, blood and urine samples will be collected to measure levels of certain substances (C3a, C5a, and factor Bb) that indicate inflammation in your body.

  4. Step 4

    Week 12 evaluation

    At week 12, blood and urine samples will be collected again to measure levels of C3a, C5a, and factor Bb.

  5. Step 5

    Week 20 evaluation

    At week 20, several assessments will be performed:

    Your disease activity will be evaluated using the Birmingham Vasculitis Activity Score (a scoring system that measures how active your disease is).

    The Vasculitis Damage Index will assess any permanent damage caused by the disease.

    Your kidney function will be measured through estimated glomerular filtration rate (eGFR, a calculation based on a blood test that shows how well your kidneys are filtering waste).

    Urine tests will measure protein and albumin levels to assess kidney damage.

    It will be determined whether you require chronic dialysis (a treatment that filters waste from your blood when kidneys cannot do so adequately).

    Blood and urine samples will be collected to measure levels of C3a, C5a, and factor Bb.

    Urine samples will measure levels of MCP-1 and soluble CD163 (substances that indicate kidney inflammation).

  6. Step 6

    Week 52 evaluation

    At week 52, the main assessment of the trial will take place:

    Your kidney function will be measured to determine if your eGFR has reached 30 mL/min/1.73m² or higher. This measurement indicates whether your kidney function has improved to a safer level.

    Your disease activity will be evaluated using the Birmingham Vasculitis Activity Score.

    The Vasculitis Damage Index will be assessed.

    Your kidney function (eGFR) will be measured.

    Urine tests will measure protein and albumin levels.

    It will be determined whether you require chronic dialysis.

    Blood and urine samples will be collected to measure levels of C3a, C5a, and factor Bb.

    Urine samples will measure levels of MCP-1 and soluble CD163.

  7. Step 7

    Week 64 final evaluation

    At week 64, the final assessments will be completed:

    Your disease activity will be evaluated using the Birmingham Vasculitis Activity Score.

    The Vasculitis Damage Index will be assessed.

    Your kidney function (eGFR) will be measured.

    Urine tests will measure protein and albumin levels.

    It will be determined whether you require chronic dialysis.

    Your quality of life will be assessed using two questionnaires: the Short Form-36 version 2 and the EuroQOL-5D-5L. These questionnaires ask about your physical and mental health and overall well-being.

  8. Step 8

    Ongoing monitoring throughout the trial

    Throughout the entire trial from the beginning until week 64, you will be monitored for any side effects or complications, including infections, diabetes, hepatitis, and other adverse events.

    If serious side effects occur, if the disease does not respond to treatment (refractory vasculitis), or if the disease returns (relapse), your treatment may need to be modified or discontinued.

Who can join the trial?

10 criteria

  • You must be between 18 and 85 years old
  • You must be male or female
  • You must have a kidney biopsy (a small tissue sample taken from your kidney) available from up to 6 weeks before joining the study, or you must agree to have this procedure done before the week 4 visit
  • You must have been newly diagnosed or have a returning active ANCA-associated vasculitis (a condition where your immune system attacks small blood vessels) affecting your kidneys at the time of joining the study. This includes two types called granulomatosis with polyangiitis or microscopic polyangiitis
  • You must have active disease, which means you have a disease activity score of at least 3 points, with at least one of two kidney-related signs: either protein in your urine (more than 300 milligrams per gram) or blood in your urine (more than 10 red blood cells per high-power field when examined under a microscope)
  • Your kidney function must be severely reduced, with an eGFR (a measurement of how well your kidneys filter waste) between 0 and 29 at the time of joining
  • You must be planned to receive standard treatment that includes either rituximab or cyclophosphamide (medicines that suppress the immune system) plus glucocorticoids (steroid medicines), with or without plasma exchanges (a procedure to clean your blood). These treatments may have been started up to 2 weeks before joining the study
  • You must be covered by or benefit from a social security program
  • You must sign a free, informed, and written consent form
  • If you are a woman who can become pregnant, you must be using effective contraception (birth control methods)

Who cannot join the trial?

1 criterion

  • No exclusion criteria have been provided in the available study information
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Investigated drugs

  • Avacopan

    is a medication being tested in this study to see if it can help improve kidney function in patients with a specific type of blood vessel inflammation that affects the kidneys. It is given in addition to the standard treatment that patients normally receive for this condition.

  • Glucocorticoids

    (also called steroids) are medications that reduce inflammation in the body. In this study, they are part of the standard treatment that all patients receive. These medications help control the blood vessel inflammation and are commonly used to treat this condition.

  • Placebo

    is an inactive substance that looks like the real medication but contains no active treatment. Some patients in this study will receive placebo instead of avacopan, so researchers can compare the effects of the real medication against no additional treatment.

What is already known about the treatment

Avacopan – Avacopan is a medication taken by mouth in capsule form that is used to treat ANCA-associated vasculitis, a condition where the immune system mistakenly attacks blood vessels, particularly affecting the kidneys. This drug works by blocking a specific protein called C5a receptor, which plays a key role in causing inflammation and damage to blood vessels and organs. Avacopan is classified as a complement inhibitor and represents an approved treatment option that helps preserve kidney function while potentially reducing the need for high-dose steroids in patients with this serious autoimmune disease.

Investigated diseases

ANCA-associated vasculitis – ANCA-associated vasculitis is a group of rare diseases that cause inflammation and damage to small blood vessels throughout the body. The condition occurs when the immune system mistakenly attacks the walls of small blood vessels, leading to their inflammation. This inflammation can affect various organs, particularly the kidneys, lungs, and upper respiratory tract. When the disease affects the kidneys, it can lead to rapidly progressive glomerulonephritis, which causes a quick decline in kidney function. The blood vessels become damaged and may leak or become blocked, preventing proper blood flow to affected organs. Over time, this can result in chronic kidney disease and damage to other organs where the blood vessels are inflamed.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519620-24-01Protocol codeRC31/24/0321Estimated enrolment130 patientsSponsorCentre Hospitalier Universitaire De Toulouse

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