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Study on the Effects of Povetacicept for Adults 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). This condition affects the kidneys and can lead to kidney damage over time. The study will test a treatment called Povetacicept Injection, which is given as a solution for injection under the skin. The purpose of the study is to see how effective Povetacicept is in reducing the amount of protein in the urine and in preserving kidney function compared to a placebo.

Participants in the study will receive either the Povetacicept Injection or a placebo. The study will last for a total of 104 weeks, which is about two years. During this time, participants will have regular check-ups to monitor their kidney function and the amount of protein in their urine. The study aims to see if Povetacicept can help slow down the progression of kidney disease in people with IgAN.

Throughout the study, participants will be closely monitored to ensure their safety and to gather information on how well the treatment is working. The results of this study could provide valuable insights into new treatment options for people living with Immunoglobulin A Nephropathy.

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

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as a diagnosis of Immunoglobulin A Nephropathy (IgAN) and certain kidney function measurements.

    You will receive detailed information about the study, including the purpose, procedures, and potential risks and benefits. You will have the opportunity to ask questions and provide informed consent to participate.

  2. Step 2

    Baseline assessments

    Baseline assessments will be conducted to gather initial data. These assessments may include blood tests, urine tests, and measurements of kidney function.

    The results will serve as a reference point to evaluate changes during the study.

  3. Step 3

    Randomization

    You will be randomly assigned to receive either the study medication, povetacicept, or a placebo. A placebo is a substance with no active ingredients, used to compare the effects of the study medication.

    This process is double-blind, meaning neither you nor the study team will know which treatment you are receiving.

  4. Step 4

    Treatment phase

    During the treatment phase, you will receive povetacicept or placebo through a subcutaneous injection (an injection under the skin).

    The injections will be administered according to the study schedule, which will be explained to you in detail. The treatment phase will last up to 104 weeks.

  5. Step 5

    Regular follow-up visits

    You will attend regular follow-up visits to monitor your health and the effects of the treatment. These visits will include assessments similar to the baseline assessments.

    The frequency of these visits will be outlined in the study schedule provided to you.

  6. Step 6

    End of treatment assessments

    At the end of the treatment phase, final assessments will be conducted to evaluate the effects of the study medication on your condition.

    These assessments will help determine the efficacy of povetacicept in reducing protein levels in urine and preserving kidney function.

  7. Step 7

    Study completion

    After completing the study, you will receive information about the overall results and any next steps regarding your health care.

    Your participation will contribute to understanding the treatment of Immunoglobulin A Nephropathy.

Who can join the trial?

6 criteria

  • Must have a diagnosis of Immunoglobulin A Nephropathy (IgAN), confirmed by a kidney biopsy.
  • Must have a 24-hour urine protein excretion of at least 1.0 gram per day, or a 24-hour urine protein-to-creatinine ratio (uPCR) of at least 0.75 grams per gram.
  • Must have an estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73m2. This is a measure of how well the kidneys are filtering blood.
  • Must be on a stable dose of an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin II receptor blocker (ARB), which are types of medications used to treat high blood pressure and kidney problems.
  • Both males and females are eligible to participate.
  • Participants must be within the specified age range for the study.

Who cannot join the trial?

10 criteria

  • Patients with any other kidney disease besides Immunoglobulin A Nephropathy cannot participate.
  • Patients who have had a kidney transplant are not eligible.
  • Patients with severe liver disease cannot join the study.
  • Patients with uncontrolled high blood pressure are excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of cancer in the last 5 years are not eligible.
  • Patients with a known allergy to the study medication cannot join.
  • Patients who are currently participating in another clinical trial are excluded.
  • Patients with a history of drug or alcohol abuse in the last year cannot participate.
  • Patients with any serious medical condition that might interfere with the study are not eligible.
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Investigated drugs

Povetacicept is a medication being studied for its potential to help people with a kidney condition called Immunoglobulin A Nephropathy. This condition can cause damage to the kidneys over time. Povetacicept is designed to reduce the amount of protein in the urine, which is a sign of kidney damage. By lowering protein levels in the urine, the medication aims to protect the kidneys and help them function better for a longer period. The study is looking at how well Povetacicept works compared to a placebo, which is a substance with no active medication, to see if it can effectively preserve kidney function in patients with this condition.

What is already known about the treatment

Povetacicept – Povetacicept is administered as an injection, typically given under the skin. It is currently being studied in clinical trials for its potential use in treating Immunoglobulin A Nephropathy, a kidney disease. The main goal of this medication is to reduce the amount of protein in the urine and help maintain kidney function. At the molecular level, povetacicept works by modulating the immune system to prevent damage to the kidneys. It is classified as an immunomodulatory agent, which means it helps regulate the immune system's activity.

Investigated diseases

Immunoglobulin A Nephropathy – Immunoglobulin A 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. The disease often progresses slowly over many years. Symptoms may include blood in the urine, protein in the urine, and swelling in the hands and feet. As the disease progresses, it can lead to chronic kidney disease.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514135-17-00Protocol codeAIS-D08Estimated enrolment527 patientsSponsorAlpine Immune Sciences 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.

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).