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Study on Sibeprenlimab for Patients with IgA Nephropathy

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 clinical trial is focused on studying a kidney disease called Immunoglobulin A Nephropathy (IgAN). IgAN is a condition where a protein called IgA builds up in the kidneys, causing inflammation and affecting their ability to filter waste from the blood. The trial will evaluate a treatment called Sibeprenlimab, which is a type of medication known as a monoclonal antibody. Monoclonal antibodies are proteins made in a lab that can bind to specific substances in the body. Sibeprenlimab is administered as a solution for injection under the skin, a method known as subcutaneous use. The study will also involve a placebo, which is a substance with no active medication, to compare the effects of Sibeprenlimab.

The purpose of the study is to assess the effectiveness and safety of Sibeprenlimab in treating IgAN. Participants in the trial will receive either Sibeprenlimab or a placebo, in addition to their standard care, for a period of nine months. The trial will monitor changes in the levels of protein in the urine, which is a key indicator of kidney function. The study will also track the overall health and kidney function of participants over a longer period to gather more information about the treatment's impact.

Throughout the trial, participants will undergo regular check-ups and tests to ensure their safety and to collect data on how well the treatment is working. The trial aims to provide valuable insights into whether Sibeprenlimab can be an effective treatment option for people with IgAN, potentially improving their kidney health and quality of life.

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

    Joining the trial

    Upon joining the trial, participants will be informed about the study's purpose, which is to evaluate the effectiveness and safety of a medication called sibeprenlimab for treating a kidney condition known as IgA nephropathy.

    Participants will be randomly assigned to receive either the medication sibeprenlimab or a placebo, which is a substance with no active medication, to compare the effects.

  2. Step 2

    Medication administration

    The medication sibeprenlimab will be administered as a solution for injection under the skin, known as subcutaneous use.

    Participants will receive the medication or placebo regularly over a period of 9 months.

  3. Step 3

    Monitoring and assessments

    Throughout the trial, participants will undergo regular monitoring to assess the medication's effects. This includes collecting 24-hour urine samples to measure protein levels and conducting blood tests to evaluate kidney function.

    Participants will also have their vital signs checked and may undergo physical examinations to ensure their safety during the trial.

  4. Step 4

    End of trial evaluation

    At the end of the 9-month period, participants will have a final evaluation to determine the change in their condition compared to the beginning of the trial.

    The primary focus will be on the change in urine protein levels, while secondary assessments will include kidney function and overall health status.

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of IgA Nephropathy (a kidney disease) through a kidney biopsy.
  • Must be taking a stable and maximum tolerated dose of authorized medications called ACE inhibitors or angiotensin receptor blockers for at least 3 months before the study starts. These medications help control blood pressure and protect the kidneys.
  • If taking an additional medication called SGLT2 inhibitor for IgA Nephropathy, it must have been started at least 3 months before the study begins.
  • At the start of the study, must have a urine protein-to-creatinine ratio (uPCR) of at least 0.75 g/g or urine protein of at least 1.0 g/day. This is measured from 24-hour urine samples.
  • Must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m². This is a measure of kidney function.
  • If the eGFR is between 30 to 45 mL/min/1.73 m², a kidney biopsy must have been done within 36 months before the study starts.
  • For a specific group in the study, the eGFR must be between 20 to 30 mL/min/1.73 m².
  • Both male and female participants are eligible.

Who cannot join the trial?

10 criteria

  • Patients with any other kidney disease besides IgA Nephropathy cannot participate.
  • Patients who are younger than 18 years old or older than 65 years old are not eligible.
  • Pregnant or breastfeeding women cannot take part in the study.
  • Patients who have participated in another clinical trial within the last 30 days are excluded.
  • Patients with a history of severe allergic reactions to medications are not allowed to join.
  • Patients with uncontrolled high blood pressure are not eligible.
  • Patients with severe liver disease cannot participate.
  • Patients with a history of drug or alcohol abuse in the past year are excluded.
  • Patients with any active infection that requires treatment with antibiotics are not eligible.
  • Patients who have had a major surgery within the last 3 months cannot participate.
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Investigated drugs

Sibeprenlimab is a medication being tested in this clinical trial. It is given as an injection under the skin. The purpose of this medication is to help people with a kidney condition called Immunoglobulin A Nephropathy. This condition can cause damage to the kidneys over time. The trial is looking to see if Sibeprenlimab can help reduce the amount of protein in the urine, which is a sign of kidney damage. By doing this, the medication aims to protect the kidneys and improve the health of people with this condition.

What is already known about the treatment

Sibeprenlimab – Sibeprenlimab is administered through an injection under the skin, known as subcutaneous administration. It is currently being studied in clinical trials for its effectiveness and safety in treating IgA Nephropathy, a kidney disease. The main purpose of this medication is to help reduce protein levels in the urine, which is a common problem in this condition. Sibeprenlimab works by targeting specific proteins in the body to help control inflammation and immune responses, which can help protect the kidneys. It is classified as an immunomodulatory agent, meaning it helps regulate the immune system.

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 and affect kidney function. The disease often progresses slowly over many years, and symptoms may not be noticeable in the early stages. As the condition advances, it can lead to symptoms such as blood in the urine, swelling in the hands and feet, and high blood pressure. The progression of IgA Nephropathy varies among individuals, with some experiencing a slow decline in kidney function while others may have a more rapid progression.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500079-30-00Protocol code417-201-00007Estimated enrolment530 patientsSponsorOtsuka Pharmaceutical Development & Commercialization Inc.

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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.

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