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New drug shows promise for tough kidney diseases

NCT ID NCT05732402

Disease control Sponsor: Alpine Immune Sciences, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called povetacicept in adults with certain autoimmune kidney diseases, including lupus nephritis and IgA nephropathy. The goal is to see if the drug is safe and can help control the disease. Participants receive the drug every 4 weeks for at least 6 months, with possible extensions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

72 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria Summary: Part A: * Biopsy-confirmed autoantibody-associated glomerular disease: immunoglobulin A nephropathy (IgAN), primary membranous nephropathy (pMN), or lupus nephritis (LN) * On maximal dose or the maximally tolerated dose ACEis/ARBs for ≥12 weeks prior to study Day 1 * Indication-specific criteria: 1. IgAN * Biopsy-confirmed diagnosis less than or equal to (≤)10 years prior to the start of screening AND Screening UPCR greater than or equal to (≥)0.5 g/g. * No background immunosuppression therapies. 2. pMN * A historical biopsy-confirmed diagnosis with positive anti-PLA2R1 antibodies or anti-THSD7A antibodies at screening AND Screening UPCR ≥1 g/g * Inadequate reduction of proteinuria determined by the Principal Investigator (PI) despite optimal supportive care for at least 12 weeks. * No background immunosuppression therapies except for optional calcineurin inhibitors. 3. LN * A Biopsy-confirmed diagnosis of active, proliferative Class III, IV, (with or without Class V) LN ≤6 months prior to the start of screening AND Screening UPCR ≥1 g/g, * Anti-dsDNA at screening. Anti-dsDNA testing is required but the result need not be positive. * On stable background immunosuppression ≥ 8 weeks prior to Day 1 4. AAV * Past diagnosis of renal AAV, defined as either of the following: * History of renal biopsy consistent with renal AAV. * History of clinically diagnosed renal AAV. * Myeloperoxidase (MPO)-ANCA or proteinase 3 (PR3)-ANCA positive by enzyme-linked immunosorbent assay at screening. * At least 4 weeks since initiation of AAV induction therapy, if applicable. Part B: * Participants meet at least 1 of the following criteria: * Completed investigational product (IP) treatment and 24 weeks of follow-up in Part A, or * Had IP interruption(s) in Part A, but did not permanently discontinue IP, and completed study visits up to the last scheduled visit of the follow-up period of Part A. Key Exclusion Criteria Summary: Part A: * Prior diagnosis of, or fulfills diagnostic criteria for, another renal disease * eGFR \<30 milliliter per minute per square meter (mL/min/1.73m\^2) or rapidly progressive glomerulonephritis * Recent serious or ongoing infection; risk or history of serious infection * Receipt of B cell depleting therapies or anti-BAFF and/or APRIL therapies within protocol specified timeframes Part B: * History of poor compliance with IP and/or procedures in Part A, as deemed by the investigator or Sponsor * History of any AEs or clinical conditions during Part A or emerging thereafter that may pose a safety concern for participation in Part B as deemed by investigator or Sponsor. Other protocol defined Inclusion/Exclusion criteria will apply

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Conditions

The condition(s) this trial relates to.

anti-neutrophil cytoplasmic antibody-associated vasculitis eosinophilic granulomatosis with polyangiitis granulomatosis with polyangiitis idiopathic membranous glomerulonephritis IgA glomerulonephritis lupus nephritis membranous glomerulonephritis microscopic polyangiitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anti-neutrophil cytoplasmic antibody-associated vasculitis Immunoglobulin A nephropathy Lupus nephritis Membranous nephropathy

Contacts and locations

Locations

  • Investigational Site (102)

    Nedlands, Western Australia, 6009, Australia

  • Investigational Site (116)

    Suwon, Gyeonggi-do, 16499, South Korea

  • Investigational Site (118)

    Colleyville, Texas, 76034, United States

  • Investigational Site (125)

    Seoul, Gyeonggi-do, 03080, South Korea

  • Investigational Site (191)

    Caguas, 00725, Puerto Rico

  • Investigational Site (501)

    Phoenix, Arizona, 85302, United States

  • Investigational Site (502)

    Lawrenceville, Georgia, 30046, United States

  • Investigational Site (503)

    Boston, Massachusetts, 02115, United States

  • Investigational Site (504)

    Goyang-si, Gyeonggi-do, 10444, South Korea

  • Investigational Site (505)

    Anyang-si, Gyeonggi-do, 14068, South Korea

  • Investigational Site (506)

    Valencia, California, 91335, United States

  • Investigational Site (507)

    Cheonan, Chungcheongnam-do, 31151, South Korea

  • Investigational Site (508)

    Brooklyn, New York, 11203, United States

  • Investigational Site (509)

    Newark, New Jersey, 07103, United States

  • Investigational Site (510)

    Guri-si, Gyeonggi-do, 11923, South Korea

  • Investigational Site (511)

    Albany, New York, 12209, United States

  • Investigational Site (512)

    Orlando, Florida, 32806, United States

  • Investigational Site (513)

    Arvada, Colorado, 80002, United States

  • Investigational Site (515)

    Saint Albans, Victoria, 3021, Australia

  • Investigational Site (516)

    Houston, Texas, 77054, United States

  • Investigational Site (518)

    Bethlehem, Pennsylvania, 18017, United States

  • Investigational Site (519)

    Concord, New South Wales, 2139, Australia

  • Investigational Site (520)

    Seoul, Gyeonggi-do, 03181, South Korea

  • Investigational Site (521)

    Seoul, Gyeonggi-do, 05278, South Korea

  • Investigational Site (523)

    Phoenix, Arizona, 85016, United States

  • Investigational Site (524)

    Tucson, Arizona, 85712, United States

  • Investigational Site (525)

    Tamarac, Florida, 33321, United States

  • Investigational Site (526)

    Irving, Texas, 75061, United States

  • The Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21224, United States

  • Washington University School of Medicine in St. Louis

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.