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Study of Monthly Atacicept Injections in Patients with IgA Nephropathy (Berger Disease)

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 IgA Nephropathy (also known as Berger's Disease), which is a kidney condition where proteins called immunoglobulins build up in the kidneys and cause damage. The study will test a medication called atacicept (VT-001), which is given as an injection under the skin once every four weeks.

The purpose of this research is to evaluate how atacicept affects certain proteins in patients with IgA Nephropathy. The medication comes in the form of a pre-filled syringe containing a solution for injection. During the study, participants will receive monthly injections of the study medication for 24 weeks.

Throughout the study period, various measurements will be taken to monitor protein levels in the blood and urine, as well as to check how well the medication is working and ensure patient safety. The total duration of treatment may last up to 48 weeks, during which patients will continue to receive their usual standard of care treatments for their condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    You will receive a detailed evaluation to confirm your diagnosis of IgA Nephropathy (IgAN), also known as Berger Disease

    Your blood pressure will be checked to ensure it meets the required levels (systolic ≤160 mmHg and diastolic ≤90 mmHg)

    Your kidney function will be assessed through tests measuring protein in urine and estimated glomerular filtration rate (eGFR)

  2. Step 2

    Treatment initiation

    You will receive atacicept as a solution for injection under the skin (subcutaneous injection)

    The medication will be provided in pre-filled syringes

    The treatment will be administered every 4 weeks (monthly)

  3. Step 3

    Monitoring through week 24

    Regular blood tests will be performed to measure levels of specific proteins (Gd-IgA1, IgG, IgM, and IgA)

    Your urine will be tested to measure protein levels using the urine protein-to-creatinine ratio (UPCR)

    Blood samples will be taken to measure the amount of atacicept in your system

    Tests will be conducted to check for antibodies against the study medication

  4. Step 4

    Safety monitoring

    Regular laboratory tests will be performed to monitor your health

    Your vital signs will be checked during study visits

    Any side effects will be recorded and monitored throughout the study

    The study will continue monitoring your health until the end of the study period

Who can join the trial?

8 criteria

  • Must be at least 18 years old and able to provide written informed consent before any study procedures
  • Must have confirmed IgA Nephropathy through kidney biopsy with either:
    • Total urine protein of at least 0.75 grams in a 24-hour period, or
    • Urine protein-to-creatinine ratio of at least 0.75 mg/mg from a 24-hour urine sample
    • Must have adequate kidney function with eGFR (estimated glomerular filtration rate - a measure of kidney function) of at least 30 ml/min/1.73m²
    • Must be on a stable prescribed standard of care treatment according to local medical practice
    • Must have controlled blood pressure with:
      • Systolic blood pressure (upper number) not higher than 160 mmHg
      • Diastolic blood pressure (lower number) not higher than 90 mmHg
      • Both men and women can participate in the study

Who cannot join the trial?

15 criteria

  • History of kidney transplant or currently on dialysis
  • Known allergies to study medications
  • Presence of other types of kidney diseases besides IgA Nephropathy
  • Active infections or serious illnesses
  • Liver disease or abnormal liver function tests
  • Uncontrolled high blood pressure (blood pressure consistently above 140/90)
  • Pregnant women or planning pregnancy during the study period
  • Breastfeeding mothers
  • Use of other investigational drugs within 30 days before study start
  • History of cancer within the past 5 years
  • Active autoimmune diseases (conditions where the immune system attacks healthy cells)
  • Blood disorders or significant abnormalities in blood tests
  • History of substance abuse within the past year
  • Mental conditions that could interfere with study participation
  • Unable to provide informed consent
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Investigated drugs

Atacicept is a medication that targets specific proteins in the immune system. It works by reducing the production of certain antibodies that can cause damage to the kidneys in patients with IgA nephropathy (IgAN). This medication is designed to be given once every four weeks and aims to help patients who have a condition where abnormal antibodies build up in their kidneys.

What is already known about the treatment

Atacicept - A biological medication administered through subcutaneous injection every four weeks, specifically developed for treating IgA Nephropathy (IgAN), also known as Berger's Disease. This innovative drug works by targeting and reducing galactose-deficient IgA1 (Gd-IgA1) levels in the body, which is a key factor in the development of kidney damage in IgAN patients. Atacicept belongs to the class of immunomodulating agents and functions by binding to specific proteins that regulate B-cell activity, helping to reduce harmful antibody production that causes kidney inflammation. The medication is currently being evaluated in clinical trials for its effectiveness in treating IgA Nephropathy, representing a promising therapeutic approach for patients with this rare kidney disease.

Investigated diseases

IgA Nephropathy (Berger Disease) - A kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys. This accumulation of IgA creates inflammation that gradually affects the kidney's filtering ability. The disease develops slowly over many years, and the body's immune system produces an abnormal form of IgA that collects in the kidneys. As the IgA deposits build up, they cause inflammation and damage to the kidney tissues. The condition primarily affects the glomeruli, which are the tiny filtering units in the kidneys. The disease can occur at any age, but it most often develops during adolescence or early adulthood.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521519-37-00Protocol codeVT-001-0020Estimated enrolment90 patientsSponsorVera Therapeutics Inc.

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