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Study of felzartamab compared to placebo in adults with IgA nephropathy

Fast replyRegistered drugNo 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, a kidney disease where abnormal antibodies build up in the kidneys. The main treatment being tested is Felzartamab, which is given through intravenous administration. The study will compare this medication against a placebo to see how well it works in reducing protein in the urine of adult patients with this condition.

Several supportive medications may be used during the study, including Desloratadine, Diphenhydramine, Cetirizine, Fexofenadine, Paracetamol, Methylprednisolone, Levocetirizine, Loratadine, and Famotidine. These medications are used to manage potential side effects or symptoms that participants might experience during the treatment. A Saline solution will also be used as part of the treatment process.

The purpose of this research is to evaluate how effective Felzartamab is compared to placebo in reducing the amount of protein in the urine of people with IgA Nephropathy. The study will last several years, during which participants will receive regular infusions of either Felzartamab or placebo, and their kidney function will be monitored through various tests.

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 Treatment Phase

    You will receive either felzartamab or placebo through intravenous administration (into a vein).

    During treatment, you must continue taking your current kidney medications at stable doses, including ACE inhibitors or ARB medications.

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

  2. Step 2

    Pre-medication Protocol

    Before each felzartamab infusion, you will receive medications to prevent possible reactions:

    - Antihistamines (such as diphenhydramine, cetirizine, or desloratadine)

    - Paracetamol

    - Methylprednisolone

  3. Step 3

    Monitoring Phase

    Regular checks will measure:

    - Changes in protein levels in your urine

    - Kidney function through blood tests

    - Physical examination and vital signs

    - Heart activity through ECG testing

    - Presence of antibodies against the study medication

  4. Step 4

    Long-term Follow-up

    The study continues until June 2029

    Your kidney function will be monitored for signs of improvement or decline

    Any side effects or health changes will be documented and assessed

Who can join the trial?

8 criteria

  • Must have IgA nephropathy confirmed by kidney biopsy within the last 10 years. For patients with type 2 diabetes, the biopsy must be from the last 24 months
  • Must have adequate kidney function measured by eGFR (a blood test that shows how well your kidneys are working): - At least 30 mL/min/1.73m² for most patients - Between 20-30 mL/min/1.73m² may be accepted for specific study groups
  • Must be on a stable dose of blood pressure medications (ACE inhibitors or ARBs) for at least 12 weeks, or have documented intolerance to these medications
  • May be taking other medications for kidney disease (SGLT2 inhibitors, endothelin receptor blockers, or mineralocorticoid receptor blockers) if the dose has been stable for at least 12 weeks
  • Must have significant protein in urine, shown by either: - At least 1.0 gram of protein in a 24-hour urine collection, or - A urine protein-to-creatinine ratio of at least 0.8 grams per gram
  • Both men and women can participate
  • Must be an adult (18 years or older)
  • If taking a medication called sparsentan, cannot be taking ACE inhibitors or ARBs at the same time

Who cannot join the trial?

13 criteria

  • History of organ transplant or current plans for kidney transplant
  • Active hepatitis B or C infection (viral infections affecting the liver)
  • Known HIV infection
  • Current diagnosis of cancer or cancer treatment in the past 5 years
  • Other types of kidney diseases besides IgA nephropathy
  • History of severe allergic reactions to medications
  • Pregnancy or breastfeeding
  • Participation in other clinical trials within the past 30 days
  • Severe heart disease or uncontrolled high blood pressure
  • Serious infections requiring hospitalization within the past 3 months
  • Use of certain medications that affect the immune system
  • Alcohol or drug abuse within the past year
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

  • Felzartamab

    is an investigational medication being studied for the treatment of IgA nephropathy, which is a kidney disease. It works by targeting and reducing specific antibodies in the body that contribute to kidney inflammation and damage. This medication is given to patients alongside their standard treatments to help reduce the amount of protein in their urine, which is a sign of kidney disease severity.

  • Placebo

    is an inactive substance that contains no medication. It is used as a comparison to help determine if felzartamab is effective in treating IgA nephropathy.

What is already known about the treatment

Felzartamab - A novel monoclonal antibody administered through intravenous infusion, currently undergoing Phase 3 clinical trials for the treatment of IgA nephropathy (IgAN), a kidney disease characterized by accumulation of immunoglobulin A in the kidneys. The medication works by targeting and depleting specific immune cells that produce IgA antibodies, potentially reducing the harmful buildup of these antibodies in kidney tissue. As an immunotherapy agent in the class of targeted monoclonal antibodies, felzartamab represents a promising therapeutic approach for patients with IgA nephropathy who currently have limited treatment options.

Investigated diseases

IgA Nephropathy - A kidney disease where an antibody called immunoglobulin A (IgA) builds up in the kidneys. The disease occurs when IgA deposits in the kidneys, causing inflammation that can interfere with the kidneys' ability to filter waste from blood. It develops gradually over many years and primarily affects the kidney's filtering units called glomeruli. The condition often starts during the teenage years or early adulthood. Over time, it can cause protein and blood to leak into the urine, leading to changes in urination patterns and visible blood in urine. The disease progresses differently in each person, with some experiencing very slow progression while others notice more rapid changes in kidney function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-519345-30-00Protocol code299IG301Estimated enrolment561 patientsSponsorBiogen Idec Research Limited

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).