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A Study of Povetacicept Compared to Tacrolimus for Adults with Primary Membranous Nephropathy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves people with Primary Membranous Nephropathy, a kidney disease where the filtering units of the kidneys become damaged and thickened, leading to protein leaking into the urine. The study will test a treatment called ALPN-303, which is also known as povetacicept, and compare it to a standard treatment called a calcineurin inhibitor, which in this study is tacrolimus. Povetacicept is given as an injection under the skin, while tacrolimus is taken by mouth as a capsule. The purpose of the study is to find out how well povetacicept works in treating this kidney condition and to check how safe it is.

Participants will be randomly assigned to receive either povetacicept or tacrolimus. The study will last up to 72 weeks, during which time participants will receive their assigned treatment and attend regular visits for monitoring. During these visits, various tests will be performed to check kidney function, measure protein levels in the urine, and monitor overall health. Blood tests, heart tracings, and other measurements will be taken to ensure the treatments are working properly and to watch for any unwanted effects.

The main goal is to see how many participants achieve complete remission of their kidney disease, which means their kidney function has improved and the amount of protein in their urine has decreased to normal or near-normal levels. The study will also look at different definitions of improvement and will carefully track any side effects or health changes that occur during treatment. This information will help doctors understand whether povetacicept could be a useful treatment option for people with this type of kidney disease.

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

    Treatment assignment

    Upon entering the study, you will be randomly assigned to receive one of two treatment options. Random assignment means that neither you nor your doctor can choose which treatment you will receive.

    You will receive either povetacicept or a calcineurin inhibitor (specifically tacrolimus). A calcineurin inhibitor is a medication that affects your immune system.

  2. Step 2

    Receiving povetacicept treatment

    If you are assigned to receive povetacicept, the medication will be administered as an injection under the skin (subcutaneous injection).

    The medication will be provided either in a pre-filled syringe or as a solution for injection.

    Your doctor will provide specific instructions regarding the frequency and duration of these injections based on the study protocol.

  3. Step 3

    Receiving tacrolimus treatment

    If you are assigned to receive tacrolimus, the medication will be taken by mouth (oral use).

    Your doctor will provide specific instructions regarding the dosage, frequency, and duration of this medication based on the study protocol.

  4. Step 4

    Study assessments through week 72

    Throughout the study, your condition will be monitored at regular intervals up to week 72.

    During these visits, various assessments will be conducted to evaluate how well the treatment is working and to monitor your safety.

    These assessments will include blood tests to check laboratory values, electrocardiograms (ECGs, which are tests that measure the electrical activity of your heart), vital signs measurements (such as blood pressure and heart rate), and monitoring for any adverse events (unwanted or harmful effects).

    The primary assessment will focus on whether you achieve complete clinical remission, which means that signs of your kidney disease have significantly improved or disappeared.

  5. Step 5

    Completion of treatment period

    The main treatment and assessment period will continue until week 72.

    At this point, your response to treatment will be evaluated to determine the effectiveness of the medication you received.

    Your doctor will assess whether you have achieved complete clinical remission or overall clinical remission, which are measures of how well your kidney condition has responded to treatment.

Who can join the trial?

4 criteria

  • You must have been diagnosed with primary membranous nephropathy, which is a kidney disease where the filtering units of the kidneys become damaged. This diagnosis must be confirmed by a previous biopsy, which is a procedure where a small piece of kidney tissue was removed and examined under a microscope. If you did not have a biopsy before, one can be done during the screening period to confirm if you can join the study.
  • You must meet other specific requirements that will be discussed with you by the study team.
  • Both men and women can participate in this study.
  • Adults and older adults can participate in this study.

Who cannot join the trial?

3 criteria

  • The study information does not provide specific exclusion criteria at this time
  • Exclusion criteria are the reasons why some people cannot join a clinical trial, such as having certain other health conditions, taking specific medications, or having test results that fall outside the study requirements
  • If you are interested in this study, the research team will review all requirements with you to determine if you are able to participate
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Investigated drugs

  • Povetacicept

    is an investigational medication being studied for the treatment of primary membranous nephropathy, which is a kidney disease. This medication is being tested to see if it can help improve kidney function and reduce protein loss in the urine in people with this condition.

  • Calcineurin Inhibitor

    is a type of medication that suppresses the immune system and is already used to treat various kidney diseases, including membranous nephropathy. In this study, it serves as the comparison treatment to see how well povetacicept works against an established therapy.

What is already known about the treatment

Povetacicept – Povetacicept is an investigational medication currently being studied in clinical trials for the treatment of Primary Membranous Nephropathy, a kidney disease that affects the filtering units of the kidneys. This drug is being tested in a Phase 2b/3 study to evaluate how well it works compared to another type of medication called calcineurin inhibitors, which are currently used to treat this condition. Povetacicept is designed to target specific proteins in the immune system that are believed to cause damage to the kidney's filtering membranes, though its exact mechanism involves blocking certain immune signals that lead to kidney inflammation and protein loss in the urine. The medication belongs to a class of drugs that modify the immune system's response, aiming to reduce kidney damage and preserve kidney function in patients with this autoimmune kidney disorder.

Investigated diseases

Primary Membranous Nephropathy – Primary Membranous Nephropathy is a kidney disease that affects the filters in the kidneys called glomeruli. The condition occurs when the immune system mistakenly attacks the kidney's filtering membranes, causing them to become thick and damaged. This damage leads to protein leaking from the blood into the urine, a condition known as proteinuria. As the disease progresses, the kidneys gradually lose their ability to filter waste products effectively. People with this condition often experience swelling in the legs, ankles, and around the eyes due to fluid retention. The disease develops slowly over time and can vary in severity from person to person.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-521661-27-00Protocol codeVX24-AIS-D10Estimated enrolment121 patientsSponsorVertex Pharmaceuticals Inc.

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