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Long-term safety and effectiveness study of atacicept in patients with IgA nephropathy (IgAN)

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This study focuses on patients with IgA Nephropathy (IgAN), a kidney disease that affects the filtering units of the kidneys. The study will test a medication called atacicept, which is given as an injection under the skin using either a pre-filled syringe or an auto-injector device. The purpose is to evaluate how safe and effective this medication is when used for a long time.

During the study, participants who previously completed treatment with atacicept in an earlier IgAN study will continue receiving the medication. The treatment will be given through subcutaneous (under the skin) injections, with doses up to 150 milligrams. The study medication will be provided in two forms: a ready-to-use pre-filled syringe or an auto-injector device for self-administration.

The study will monitor participants' kidney function and overall health through regular medical check-ups and laboratory tests. The treatment period may last up to 156 weeks, during which doctors will track any side effects and measure how well the medication works by checking protein levels in urine and monitoring kidney function. Participants' blood pressure and other health indicators will be regularly monitored throughout the study period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial qualification

    You will undergo initial qualification if you have completed previous treatment with atacicept in a parent study for IgAN (immunoglobulin A nephropathy).

    Your blood pressure must be below 150/90 mmHg at screening and Day 1 (applicable for Drug Holiday Group).

    Your kidney function will be assessed through eGFR test, which must be ≥20 mL/min/1.73 m² at screening (applicable for Drug Holiday Group).

  2. Step 2

    Medical requirements verification

    If you were assigned female at birth, a pregnancy test will be conducted - both serum test at screening and urine test on Day 1.

    Your current medications will be reviewed to ensure you are on a stable dose of blood pressure medication (ACEi or ARB) if you are in the Drug Holiday Group.

  3. Step 3

    Treatment administration

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

    The medication will be provided either in a pre-filled syringe or autoinjector combination.

  4. Step 4

    Monitoring and assessments

    Your kidney function will be regularly monitored through urine and blood tests.

    Tests will measure protein levels in urine (UPCR and UACR)

    Your kidney filtering function (eGFR) will be assessed through blood tests measuring creatinine and cystatin C levels.

    Urine tests will check for presence of blood (hematuria).

    Blood tests will measure Gd-IgA1 levels.

  5. Step 5

    Safety monitoring

    Regular clinical and laboratory tests will be conducted to monitor your health.

    Any side effects or adverse events will be recorded and monitored.

    The study will continue until approximately April 2028.

Who can join the trial?

8 criteria

  • Must be able to understand and sign an informed consent form before starting any study procedures
  • Must have completed previous treatment with atacicept in a parent study for IgAN (a kidney disease)
  • For patients in the Drug Holiday Group:
    • Blood pressure must be no higher than 150/90 mmHg at screening and first day
    • Kidney function (eGFR) must be at least 20 mL/min/1.73 m2 at screening
    • Must be taking stable doses of blood pressure medications (ACEi or ARB) at the maximum tolerated dose
    • For female participants:
      • Must not be pregnant (confirmed by blood test at screening and urine test on day 1)
      • Must not be breastfeeding for at least 3 months before screening
      • Must either be unable to have children, or if able to have children, must use highly effective birth control (99% effective) from 7 days before study start until 175 days after last dose

Who cannot join the trial?

15 criteria

  • History of severe allergic reactions or anaphylaxis to biological agents
  • Active or chronic infections, including hepatitis B, hepatitis C, or HIV
  • History of cancer within the past 5 years (except treated non-melanoma skin cancer)
  • Severe kidney dysfunction (estimated glomerular filtration rate below 30 mL/min)
  • Uncontrolled high blood pressure (systolic >160 mmHg or diastolic >100 mmHg)
  • History of blood clotting disorders or significant bleeding events
  • Current treatment with other investigational drugs or participation in another clinical trial
  • Pregnant women or women planning pregnancy during the study period
  • Active liver disease or abnormal liver function tests
  • Significant heart conditions including heart failure or recent heart attack
  • History of organ transplantation
  • Current treatment with immunosuppressive medications (drugs that weaken the immune system)
  • Recent live vaccinations within 4 weeks before starting the study
  • History of substance abuse within the past year
  • Any condition that, in the investigator's opinion, makes the patient unsuitable for the study
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Investigated drugs

Atacicept is a biological medication that works by targeting specific proteins in the immune system. It is designed to help regulate immune responses in the body. This medication is being studied for its long-term effects and safety in patients with autoimmune conditions. Atacicept is administered through injections and works by blocking certain molecules that contribute to inflammation and abnormal immune responses.

What is already known about the treatment

Atacicept - A biological medication administered through subcutaneous injection that belongs to the class of immunomodulatory drugs. It works by binding to and neutralizing two important proteins (BLyS and APRIL) that stimulate B-cell development, particularly being studied for the treatment of IgA Nephropathy (IgAN), an autoimmune kidney disease. Atacicept acts at the molecular level by reducing the production of autoantibodies and regulating B-cell function, which helps in controlling the immune response that causes kidney damage. This medication is currently being evaluated in clinical trials to assess its long-term safety and effectiveness, showing promise as a potential treatment option for patients with IgAN.

Investigated diseases

IgA Nephropathy (IgAN) - A kidney disease where abnormal IgA antibodies build up in the kidneys, causing inflammation and damage to kidney tissues. The disease occurs when these antibodies form deposits in the kidney's filtering units called glomeruli. Over time, these deposits lead to inflammation, which can cause the kidneys to leak protein and blood into the urine. IgA Nephropathy typically progresses slowly, with symptoms such as blood in the urine, protein in the urine, and swelling in hands and feet. The condition can affect both children and adults, with varying degrees of severity.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516380-81-00Protocol codeVT-001-0051Estimated enrolment544 patientsSponsorVera Therapeutics Inc.

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