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Study of Atacicept Treatment for Patients with Multiple Autoimmune Glomerular Diseases

Verified siteInvestigationalNo placebo
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What is this trial about?

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

This clinical trial focuses on testing a medication called atacicept (VT-001) in people with Multiple Autoimmune Glomerular Diseases. These are conditions where the immune system attacks the kidneys' filtering units, leading to protein leakage into urine. The study specifically looks at different types of kidney diseases, including IgA Nephropathy, Membranous Nephropathy, Minimal Change Disease, and Focal Segmental Glomerulosclerosis.

The purpose of this study is to evaluate how safe atacicept is and how well it works in reducing the amount of protein in the urine. The medication is given as a subcutaneous injection using a pre-filled syringe. Participants will receive treatment while continuing their regular standard of care medications as prescribed by their doctors.

The study will last for 52 weeks, during which participants will receive regular doses of atacicept. Throughout the study, doctors will monitor various aspects of kidney function, particularly the amount of protein in the urine and how well the kidneys are filtering blood. They will also track the levels of specific disease markers in the blood that are associated with each type of kidney disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    A screening visit will confirm if you meet the study requirements, including checking your blood pressure, weight (must be 40 kg or more), and reviewing your medical history

    Your kidney function will be assessed through proteinuria (protein in urine) measurements and eGFR (kidney function test)

  2. Step 2

    Treatment initiation

    You will receive atacicept through an injection under the skin (subcutaneous injection)

    The medication comes in a pre-filled syringe for easier administration

    You will continue your current standard treatment as prescribed by your doctor

  3. Step 3

    Week 12 assessment

    Your protein levels in urine will be measured

    Your kidney function will be monitored

    Blood samples will be taken to measure atacicept levels in your body

  4. Step 4

    Week 24 assessment

    Your response to treatment will be evaluated

    Protein levels in urine will be measured

    Blood tests will continue to monitor atacicept levels

  5. Step 5

    Week 36 main evaluation

    This is a key assessment point to measure changes in protein levels in your urine since starting treatment

    Your kidney function will be thoroughly evaluated

  6. Step 6

    Week 52 final assessment

    Final evaluation of your kidney function

    Measurement of protein levels in urine

    Final blood tests to check atacicept levels

    Overall assessment of your response to treatment

Who can join the trial?

15 criteria

  • Must be currently receiving stable prescribed standard of care treatment according to local medical guidelines
  • Blood pressure requirements:
    • For adults: systolic blood pressure must be 160 mmHg or lower and diastolic blood pressure must be 90 mmHg or lower
    • For participants aged 10-17 years: blood pressure must be below the 95th percentile for their age, gender, and height
    • Must weigh at least 40 kilograms
    • Must agree to follow the study's contraceptive guidelines
    • Disease-specific requirements:
      • For IgA Nephropathy (IgAN) patients:
        • Must have biopsy-confirmed IgAN or IgA vasculitis with nephritis
        • Protein levels in urine must be between 0.5 and 5 grams per gram of creatinine
        • Must have adequate kidney function (eGFR ≥ 20)
        • For Membranous Nephropathy (pMN) patients:
          • Must be 18 years or older
          • Must have biopsy-confirmed pMN with specific antibodies (anti-PLA2R ≥ 25 RU/mL)
          • Protein in urine must be at least 1.5 grams per gram of creatinine
          • For Minimal Change Disease (MCD) or Focal Segmental Glomerulosclerosis (FSGS) patients:
            • Must have biopsy-confirmed primary MCD or FSGS
            • Protein in urine must be at least 1.0 gram per gram of creatinine
            • Must have adequate kidney function (eGFR ≥ 30)
            • Must have evidence of specific antibodies (anti-nephrin)

Who cannot join the trial?

14 criteria

  • Age below 18 years or above 75 years
  • Known hypersensitivity (severe allergic reactions) to atacicept or any of its components
  • Currently pregnant or breastfeeding women
  • Severe kidney dysfunction (estimated glomerular filtration rate below 30 mL/min/1.73m²)
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • History of cancer within the past 5 years (except successfully treated non-melanoma skin cancer)
  • Major surgery within 8 weeks before starting the study
  • Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
  • Severe heart disease or heart failure
  • Active liver disease or significant liver function abnormalities
  • Use of other investigational drugs within 30 days or 5 half-lives before study start
  • History of drug or alcohol abuse within the past year
  • Mental conditions that could interfere with study participation
  • Any medical condition that the study doctor believes would make participation unsafe
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Investigated drugs

Atacicept is a medication being studied for treating various autoimmune diseases that affect the kidneys (glomerular diseases). It works by targeting specific proteins in the immune system that are involved in the inflammatory process. This medication aims to reduce protein in the urine (proteinuria) and help control the immune system's attack on kidney tissues.

What is already known about the treatment

Atacicept – A biological medication administered through subcutaneous injection that works by targeting and inhibiting two important proteins (BLyS and APRIL) involved in B-cell development and autoimmune responses. This drug is currently being investigated in clinical trials for the treatment of multiple autoimmune glomerular diseases, which are conditions affecting the kidneys' filtering units. As a B-cell immunomodulator, atacicept reduces the production of harmful antibodies that can damage the kidneys, potentially helping to decrease protein leakage into urine (proteinuria) in patients with autoimmune kidney disorders. The medication belongs to the class of immunosuppressive agents and represents a targeted approach to treating autoimmune kidney diseases.

Investigated diseases

  • Multiple Autoimmune Glomerular Disease

    A group of kidney disorders where the immune system attacks and damages the glomeruli, the tiny filtering units in the kidneys. The condition typically involves inflammation of the glomeruli, leading to protein leakage into urine (proteinuria). The disease can affect both kidneys simultaneously and often progresses gradually over time. Different forms of this condition can involve various immune system components attacking different parts of the kidney's filtering system. The damage to glomeruli can cause problems with the kidney's ability to filter waste products from the blood.

  • IgA Nephropathy

    A kidney disease that occurs when immunoglobulin A (IgA) builds up in the kidneys, causing inflammation that damages kidney tissues. The disease progresses slowly and affects the kidney's filtering units called glomeruli. It causes protein and blood to leak into the urine. The condition often develops during early adulthood.

  • Membranous Nephropathy

    A kidney disease characterized by thickening of the glomerular basement membrane due to immune deposits. The condition causes damage to the filtering membranes in the kidneys, leading to significant protein loss in the urine. It develops gradually and primarily affects adults. The disease can result in swelling in various body parts due to protein loss.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518465-10-00Protocol codeVT-001-0060Estimated enrolment250 patientsSponsorVera Therapeutics Inc.

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