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Phase 3 Study of ZIGAKIBART (BION-1301) 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

The study focuses on IgA nephropathy, a rare kidney condition in which a protein called IgA builds up in the kidneys and can reduce their ability to filter waste. The treatment being tested is a medication known as BION-1301, which contains the active substance ZIGAKIBART. The aim of the research is to see whether this drug can preserve kidney function compared with an inactive substance, called a placebo.

Adults with the condition are randomly assigned to receive either the study drug or the placebo, and neither the participants nor the study staff know which one is given (a double‑blind design). The medication is given as an injection under the skin (subcutaneous) at a set dose, and participants are followed for about two years. Throughout the study, routine blood tests are used to calculate the estimated glomerular filtration rate (eGFR), a measure of how well the kidneys are working, and urine collections are checked for protein levels (proteinuria) to monitor kidney health.

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 and baseline assessments

    After joining the study, you will attend an initial clinic visit where basic health information is recorded.

    Your kidney function will be measured using the estimated glomerular filtration rate (egfr) test, and a 24‑hour urine sample will be collected to assess protein in the urine (proteinuria).

    The first injection will be given on the same day. the test medication, bion 1301/fub523, is a subcutaneous (under the skin) injection of 600 mg in a solution for injection. if you are assigned to the placebo group, you will receive an injection that looks identical but contains no active drug.

  2. Step 2

    Regular injection visits

    You will return to the clinic at regular intervals for additional injections. the schedule follows the study protocol and continues for up to 104 weeks.

    Each visit includes a brief health check and another subcutaneous injection of either 600 mg bion 1301/fub523 or the matching placebo.

    The study remains double‑blind, meaning you and the study staff will not know which injection you receive.

  3. Step 3

    Week 40 urine protein assessment

    Around week 40, a special visit is scheduled to collect a 24‑hour urine sample.

    This sample is used to measure the urine protein:creatinine ratio (upcr), which helps evaluate changes in proteinuria.

  4. Step 4

    Ongoing monitoring of kidney function

    Throughout the study, periodic blood tests are performed to monitor your estimated glomerular filtration rate (egfr).

    These tests are done at predefined visits to track any changes from the baseline measurement.

  5. Step 5

    Final visit at week 104

    At week 104, the study concludes with a final clinic visit.

    Your kidney function will be measured again using the egfr test, and the overall change from the baseline will be recorded.

    The final injection is administered, and any remaining study procedures are completed.

Who can join the trial?

8 criteria

  • Be at least 18 years old when you sign the consent form.
  • Have a kidney biopsy that confirmed IgA nephropathy (IgAN) within the last 10 years; if the old report is not available, a new biopsy may be needed.
  • Show a kidney function score called estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m² or higher (for a special group, the score can be between 20 and less than 30). This test measures how well the kidneys filter waste.
  • Have urine protein of at least 1.0 gram per day or a protein‑to‑creatinine ratio (UPCR) of 0.7 g/g, measured from a complete 24‑hour urine collection. This indicates the amount of protein leaking into the urine.
  • Be on a stable, highest dose you can tolerate of an ACE inhibitor or ARB medication for at least 12 weeks, unless you cannot tolerate them; you may also be taking stable doses of a SGLT2 inhibitor, ERA, or MRA for at least 12 weeks. These are medicines that help protect the kidneys.
  • Weigh between 45 kg and 150 kg at the screening visit.
  • If you could become pregnant, agree to follow the study’s birth‑control plan from screening until about five drug half‑lives after the last dose (the time it takes for the drug level to reduce by half).
  • Provide written informed consent and be willing to attend study visits and follow the study procedures.

Who cannot join the trial?

16 criteria

  • Secondary forms of IgA nephropathy caused by other systemic illnesses, infections, autoimmune diseases, or cancers are not allowed.
  • Anyone who took systemic corticosteroid medicines (including budesonide) for more than 14 days within the 12 weeks before screening cannot join.
  • People using any systemic immunosuppressant drugs (medications that lower the immune system) are excluded.
  • Having a current severe infection that needs antibiotics, or a history of repeated severe infections, makes a person ineligible.
  • A positive blood test for HIV or hepatitis infection (viral infections of the immune system or liver) is an exclusion.
  • Receiving a live vaccine (a vaccine containing weakened live virus) within 12 weeks before screening, or planning to receive one within 6 months after the last study dose, disqualifies participation.
  • Being pregnant, breastfeeding, planning to become pregnant, or planning to donate sperm during the study and until 24 weeks after the last dose is not allowed.
  • Anyone already taking part in another clinical trial with an experimental drug or device cannot enroll.
  • Having a diagnosis of IgA Vasculitis (a blood vessel inflammation) or a current or past history of nephrotic syndrome (a condition with heavy protein loss in urine) excludes a participant.
  • Having an average blood pressure higher than 150/90 mm Hg (systolic/diastolic) is a reason for exclusion.
  • If doctors suspect rapidly progressive glomerulonephritis (RPGN) (a fast‑moving kidney inflammation) based on KDIGO guidelines, the person cannot join.
  • Having chronic kidney disease caused by any condition other than IgA nephropathy makes a person ineligible.
  • A past diagnosis of Type 1 diabetes excludes a participant.
  • For those with Type 2 diabetes, the study excludes anyone who has: a screening HbA1c (a blood sugar measure) above 8%; kidney biopsy showing diabetic damage; a history of diabetic blood‑vessel problems; or an unstable diabetes medication plan.
  • Anyone who has previously taken a therapy that targets APRIL (a protein that influences the immune system) cannot participate.
  • People with a history of a severe allergic reaction, especially to a monoclonal antibody (a lab‑made protein that can trigger immune responses), are excluded.
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Investigated drugs

ZIGAKIBART is an experimental medicine being studied in adults with IgA nephropathy. It is given as a liquid injection under the skin (subcutaneous). The drug is designed to act on the disease process that harms the kidneys, with the aim of slowing the loss of kidney function. In the trial, participants receive this therapy to see if it can help maintain better kidney health compared with not receiving the active drug.

What is already known about the treatment

Zigakibart - It is given as a subcutaneous injection in a liquid solution, with each dose containing 600 mg. Zigakibart is an investigational orphan drug currently being studied in Phase 3 trials for a rare kidney disease called IgA nephropathy. It works by binding to a specific protein that triggers immune inflammation in the kidney, thereby reducing damage and helping the kidneys filter blood better. The drug belongs to the class of biologic monoclonal antibodies that target immune pathways.

Investigated diseases

IgA nephropathy - IgA nephropathy is a kidney disorder in which a protein called immunoglobulin A builds up in the tiny filtering units of the kidneys, leading to inflammation. It often first shows up as blood or protein in the urine. Over time the inflammation can cause the kidneys to filter less efficiently. The loss of filtering ability usually happens slowly over many years, but the rate can vary from person to person. Some people may remain stable for a long time before the kidney function gradually declines.
Trial detailsLast updated 8 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503743-34-00Protocol codeCFUB523A12301Estimated enrolment350 patientsSponsorNovartis Pharma AG

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