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Study on the Effects of Atacicept in Adults with IgA Nephropathy

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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 kidney disease called IgA Nephropathy (IgAN). The study is testing a treatment called Atacicept, which is given as an injection under the skin using a pre-filled syringe. Atacicept is a protein-based medication developed by Vera Therapeutics Inc. The trial also involves a comparison with a placebo, which is a substance with no active medication. Additionally, some participants may be taking other medications like Enalapril or Losartan, which are commonly used to manage blood pressure and kidney conditions.

The purpose of this study is to evaluate how effective Atacicept is in reducing protein levels in the urine of adults with IgA Nephropathy. Protein in the urine, known as proteinuria, is a sign of kidney damage. The study is designed to be randomized and double-blinded, meaning neither the participants nor the researchers know who is receiving Atacicept or the placebo. This helps ensure the results are unbiased. The study will take place over several weeks, with regular check-ups to monitor the participants' health and the effects of the treatment.

Participants will receive Atacicept or a placebo through subcutaneous injections, which means the medication is injected just under the skin. The study will also monitor the participants' kidney function and overall health throughout the trial. By the end of the study, researchers hope to determine if Atacicept is a safe and effective treatment option for people with IgA Nephropathy.

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 visit

    Upon joining the study, you will attend an initial visit. During this visit, you will receive detailed information about the study and what to expect. You will be asked to sign a consent form, confirming your understanding and willingness to participate.

    A series of assessments will be conducted to confirm your eligibility. These assessments may include a review of your medical history, a physical examination, and laboratory tests.

  2. Step 2

    Randomization

    Once eligibility is confirmed, you will be randomly assigned to one of the study groups. This means you may receive either the study medication, atacicept, or a placebo, which looks like the medication but does not contain the active ingredient.

    The assignment is random and neither you nor the study team will know which group you are in. This is to ensure the study results are unbiased.

  3. Step 3

    Medication administration

    If you are assigned to receive atacicept, it will be administered as a subcutaneous injection, which means it is injected under the skin. The dosage and frequency will be explained to you by the study team.

    If you are in the placebo group, you will receive injections that do not contain the active medication. The schedule for these injections will be the same as for those receiving atacicept.

  4. Step 4

    Regular follow-up visits

    Throughout the study, you will have regular follow-up visits. These visits are important to monitor your health and the effects of the treatment.

    During these visits, you may undergo various tests, such as blood tests and urine tests, to assess your response to the treatment and to check for any side effects.

  5. Step 5

    End of treatment

    At the end of the treatment period, you will have a final visit. This visit will include a comprehensive assessment to evaluate the overall impact of the treatment.

    You will be informed about the next steps and any additional follow-up that may be necessary after the study concludes.

Who can join the trial?

8 criteria

  • Must have the ability to understand and sign a written informed consent form before starting any study assessments.
  • Must be an adult male or female, aged 18 years or older, or as per the legal adult age in your country.
  • Must have a diagnosis of IgA Nephropathy (IgAN), confirmed by a kidney biopsy done within the last 10 years.
  • Must have a total urine protein excretion of at least 1.0 grams per 24 hours or a urine protein to creatinine ratio (UPCR) of at least 1.0 mg/mg, based on a 24-hour urine sample during the screening period.
  • Must have an eGFR (a measure of kidney function) of at least 30 mL/min/1.73 m² at screening, calculated using the CKD-EPI equation.
  • Must be on a stable prescribed regimen of RASi (medications like ACE inhibitors or ARBs) for at least 12 weeks at the maximum dose you can tolerate. If you cannot tolerate RASi, your IgAN management should follow standard care practices, and this must be documented by the study doctor.
  • Must have a systolic blood pressure (the top number) of 150 mmHg or lower and a diastolic blood pressure (the bottom number) of 90 mmHg or lower at screening.
  • If female, must not be pregnant or breastfeeding. You must have a negative pregnancy test at screening and on the first day of the study. If you are a woman of childbearing potential, you must agree to use a highly effective contraceptive method from at least 7 days before starting the study until 175 days after the last dose of the study drug.

Who cannot join the trial?

6 criteria

  • Patients who are not adults cannot participate. This means you must be at least 18 years old.
  • Patients with medical conditions other than IgA Nephropathy may not be eligible. IgA Nephropathy is a kidney disease.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with certain other health conditions that could interfere with the study may not be eligible. This will be determined by the study doctors.
  • Patients who are unable to follow the study procedures or attend the required visits may not be eligible.
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Investigated drugs

Atacicept is a medication being studied for its potential to help people with a kidney condition called IgA Nephropathy, or IgAN. This condition can cause the kidneys to leak protein into the urine, which is not normal. Atacicept works by targeting specific proteins in the body that are involved in the immune system. By doing this, it may help reduce the amount of protein in the urine and improve kidney function. The goal of the trial is to see if Atacicept is safe and effective for people with IgAN. Participants in the trial will receive Atacicept to see how it affects their condition compared to those who do not receive the medication.

What is already known about the treatment

Atacicept – Atacicept is administered as an injection under the skin, typically in a clinical setting. It is currently being studied in clinical trials for its potential use in treating IgA Nephropathy, a kidney disease. The medication works by targeting specific proteins in the immune system to reduce inflammation and protein levels in the urine, which are common issues in IgA Nephropathy. Atacicept is classified as an immunosuppressive agent, meaning it helps to calm down the immune system to prevent it from attacking the body's own tissues.

Investigated diseases

IgA Nephropathy – IgA Nephropathy is a kidney disease that occurs when the antibody immunoglobulin A (IgA) builds up in the kidneys. This buildup causes inflammation that can affect the kidneys' ability to filter waste from the blood. Over time, the inflammation can lead to kidney damage. The disease often progresses slowly over many years. Symptoms may include blood in the urine, protein in the urine, and swelling in the hands and feet. The progression of the disease can vary, with some individuals experiencing stable kidney function and others developing chronic kidney disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-503772-24-00Protocol codeVT-001-0050Estimated enrolment481 patientsSponsorVera Therapeutics Inc.

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