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Study on the Long-term Safety and Effectiveness of Sibeprenlimab for Patients with Immunoglobulin A Nephropathy (IgAN)

Verified siteInvestigationalNo placebo
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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 the treatment of Immunoglobulin A Nephropathy (IgAN), a kidney disease that occurs when an antibody called IgA builds up in the kidneys, leading to inflammation and damage. The treatment being tested is called Sibeprenlimab, which is a type of protein known as a monoclonal antibody. This protein is designed to target specific parts of the immune system to help reduce the effects of the disease. The purpose of the study is to evaluate the long-term safety and tolerability of Sibeprenlimab in individuals with IgAN.

Participants in the study will receive Sibeprenlimab through an injection under the skin, known as a subcutaneous injection. The study will monitor participants over a period of time to observe any side effects and to assess how well the treatment is tolerated. The study will also look at how the treatment affects kidney function over time, using measures such as the estimated glomerular filtration rate (eGFR), which is a test to check how well the kidneys are working, and the amount of protein in the urine, which can indicate kidney damage.

The trial will last for several years, allowing researchers to gather comprehensive data on the effects of Sibeprenlimab. This information will help determine if the treatment is safe and effective for long-term use in managing IgAN. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and to collect necessary data for the research.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Participation begins after completing a previous trial without safety concerns. Eligibility includes having a certain kidney function level and the ability to provide informed consent.

  2. Step 2

    Treatment with sibeprenlimab

    The medication sibeprenlimab is administered as a solution for injection under the skin. The purpose is to evaluate its long-term safety and effectiveness for treating Immunoglobulin A Nephropathy (IgAN).

  3. Step 3

    Monitoring safety and tolerability

    Safety is assessed through the occurrence of side effects, laboratory tests, vital signs, physical exams, and reactions at the injection site.

  4. Step 4

    Evaluation of kidney function

    Kidney function is monitored by measuring the estimated glomerular filtration rate (eGFR) over approximately 12 and 24 months.

    Changes in urine protein levels are also evaluated at these intervals.

  5. Step 5

    Assessment of disease progression

    Progression of chronic kidney disease is measured by changes in serum creatinine levels, eGFR, and the need for renal replacement therapy over 24 months.

  6. Step 6

    Measurement of immune response

    The trial includes monitoring changes in total serum Immunoglobulin A (IgA), Immunoglobulin G (IgG), and Immunoglobulin M (IgM) concentrations.

  7. Step 7

    Trial duration

    The trial is expected to continue until February 28, 2029.

Who can join the trial?

5 criteria

  • Participants must have completed a previous trial (either Trial 417-201-00007 or Trial VIS649-201) with most of the required doses and the final visit, without any safety issues. The trial doctor should believe that the participant might benefit from the new treatment for **IgAN**.
  • Participants must have a kidney function test result called **eGFR** that is at least 20 mL/min/1.73 m². This is a measure of how well the kidneys are working.
  • Participants must be able to give written consent, meaning they agree to join the study after understanding what it involves. They should also be able to follow all the study requirements, according to the trial doctor.
  • Both males and females can participate in the study.
  • The study includes people who might be considered vulnerable, meaning they might need extra care or protection.

Who cannot join the trial?

8 criteria

  • Patients who have a different kidney condition other than **IgA Nephropathy (IgAN)**, which is a disease that affects the kidneys.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a kidney transplant.
  • Patients who have a serious infection that requires treatment.
  • Patients who have a history of cancer, except for certain types of skin cancer that have been treated.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a condition that the study doctors believe would make it unsafe for them to participate.
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Investigated drugs

Sibeprenlimab is a medication being studied for its long-term safety and effectiveness in treating patients with Immunoglobulin A Nephropathy (IgAN). It is administered through an injection under the skin. The trial aims to understand how well patients tolerate this medication over an extended period.

What is already known about the treatment

Sibeprenlimab – This medication is administered through subcutaneous injection and is currently being studied in clinical trials for its long-term safety and effectiveness. It is primarily being investigated for the treatment of Immunoglobulin A Nephropathy (IgAN), a kidney disorder. Sibeprenlimab works by targeting specific pathways involved in the immune response, aiming to reduce inflammation and kidney damage. It is classified as an immunomodulatory agent, which means it helps regulate the immune system to prevent excessive or harmful responses.

Investigated diseases

IgA Nephropathy (IgAN) – IgA Nephropathy is a kidney disease that occurs when an antibody called immunoglobulin A (IgA) builds up in the kidneys, leading to inflammation. This buildup can cause the kidneys to leak blood and protein into the urine. Over time, the inflammation can damage the kidneys' ability to filter waste from the blood. The disease often progresses slowly over many years, and in some cases, it can lead to chronic kidney disease. Symptoms may include blood in the urine, swelling in the hands and feet, and high blood pressure. The progression of the disease varies among individuals, with some experiencing only mild symptoms while others may develop more severe kidney damage.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-507233-19-00Protocol code417-201-00012Estimated enrolment595 patientsSponsorOtsuka Pharmaceutical Development & Commercialization Inc.

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