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New hope for kidney disease: Zigakibart's Long-Term safety under study

NCT ID NCT06858319

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 18, 2026 · Updated 4 times

Summary

This study looks at the long-term safety of a drug called zigakibart for adults with IgA nephropathy, a kidney disease. It is for people who have already finished a previous zigakibart study. Researchers will monitor side effects and check kidney function over 96 weeks.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jun 2031

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 to 100 years

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.

Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the OLE study. 2. Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol. 3. Per Investigator's clinical judgment, the participant may benefit from receiving open-label treatment of zigakibart 600 mg s.c. Q2W. Exclusion Criteria: 1. Participants who prematurely withdrew from zigakibart parent studies in IgAN for any reason. 2. Participants who at the time of first study treatment administration in the OLE are receiving chronic dialysis (≥30 days) or who require kidney transplantation. 3. Acute kidney injury (AKI), defined by AKIN criteria (Mehta et al 2007) within 4 weeks of first study treatment administration in the OLE study. 4. Clinical suspicion or diagnosis of rapidly progressive glomerulonephritis (RPGN), defined by KDIGO guidelines, or another glomerulopathy at the time of first study treatment administration in the OLE study. 5. Received a live vaccination within 12 weeks prior to first study treatment administration in the OLE study or plan to have a live vaccination within 6 months after the last dose of study treatment. 6. Use of systemic corticosteroid therapy (including budesonide) or other immunosuppressive therapy such as but not limited to mycophenolate, azathioprine, cyclosporine, tacrolimus, cyclophosphamide, etc., and herbs such as Tripterygium Wilfordii Hook F, Caulis sinomenii, and Sinomenium acutum for \> 2 weeks in the 12 weeks prior to first study treatment administration in the OLE study; use of rituximab within 180-days of first study treatment administration in the OLE study. 7. Current severe infection at the time of first study treatment in the OLE study or history of recurrent, severe, infections as determined by the Investigator. 8. Newly diagnosed positive serology for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who completed treatment and are persistently antibody positive but have documentation of negative HCV polymerase chain reaction \[PCR\] will be allowed), or antibodies to HIV-1 and/or HIV-2. 9. Newly diagnosed malignancy (participants with basal cell carcinoma that was completely resected or curatively treated cervical carcinoma in situ or low-risk prostate cancer (i.e., Gleason score \< 7 and prostate specific antigen \< 10 ng/mL) are eligible for the study). 10. Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose. 11. History or evidence of any other clinically significant medical or psychiatric disorder, condition, disease, or laboratory finding that, in the discretion of the Investigator, constitutes an uncertain or unfavorable benefit-risk for continued long-term therapy with zigakibart. 12. Confirmed IgG levels \< 3 g/L prior to first study treatment administration in the OLE study. 13. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, from menarche until becoming post-menopausal unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment and for 24 weeks after stopping study treatment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms). 14. Sexually active males unwilling to use a highly effective methods of contraception during intercourse while taking study treatment and for 24 weeks after stopping study treatment. In addition, male participants must not donate sperm for the time period specified above. Highly effective contraception methods for both women and men include: * Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. * Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential. * Bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking study treatment). * Sterilization (vasectomy) of male partner(s) of the female participant at least 6 months prior to first study treatment provided partner(s) has(have) received medical confirmation of surgical success. * Use of hormonal contraception methods: * Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal. * Progestogen-only hormonal contraception (where inhibition of ovulation is not the primary or only mode of action): oral, injectable or implantable. * Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS). In case of use of hormonal contraception, women should have been stable on the same method for a minimum of 3 months before taking study treatment.

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Conditions

The condition(s) this trial relates to.

autoimmune disease chronic kidney disease chronic renal failure syndrome Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications glomerular disorder glomerulonephritis IgA glomerulonephritis IgA nephropathy, susceptibility to, 1 immune system disorder kidney disorder Male Urogenital Diseases nephritis urinary system disorder Urogenital Diseases

As listed by the trial registrant

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

Glomerular disease Glomerulonephritis Glomerulonephritis, IgA Glomerulopathy Immunoglobulin disease Kidney diseases Kidney diseases, chronic Urological diseases

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    26 sites in 9 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Colorado Kidney Care Nephrology

    RECRUITING

    Denver, Colorado, 80230, United States

  • Dallas Renal Group

    RECRUITING

    Dallas, Texas, 75230, United States

  • Dallas Renal Group

    RECRUITING

    Dallas, Texas, 75230, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Knoxville Kidney Center Pllc

    RECRUITING

    Brentwood, Tennessee, 37027-4528, United States

  • NY Nephrology

    RECRUITING

    Clifton Park, New York, 12065, United States

  • Nephro Asso North Illinois Indiana

    RECRUITING

    Houston, Texas, 77024, United States

  • Nephrology Associates Of Central FL

    RECRUITING

    Orlando, Florida, 32806, United States

  • Novartis Investigative Site

    RECRUITING

    Caba, Buenos Aires, 3375, Argentina

  • Novartis Investigative Site

    RECRUITING

    La Plata, Buenos Aires, B1902COS, Argentina

  • Novartis Investigative Site

    RECRUITING

    Buenos Aires, Buenos Aires F.D., 1280, Argentina

  • Novartis Investigative Site

    RECRUITING

    Catamarca, Catamarca Province, K4700BTM, Argentina

  • Novartis Investigative Site

    RECRUITING

    Santa Fe, S3000EPV, Argentina

  • Novartis Investigative Site

    RECRUITING

    Gosford, New South Wales, 2250, Australia

  • Novartis Investigative Site

    RECRUITING

    Kogarah, New South Wales, 2217, Australia

  • Novartis Investigative Site

    RECRUITING

    Toronto, Ontario, M4C 5T2, Canada

  • Novartis Investigative Site

    RECRUITING

    Kuantan, Pahang, 25100, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Kuala Lumpur, 59100, Malaysia

  • Novartis Investigative Site

    RECRUITING

    Monterrey, Nuevo León, 64060, Mexico

  • Novartis Investigative Site

    RECRUITING

    Cheonan, Chungcheongnam-do, 330-721, South Korea

  • Novartis Investigative Site

    RECRUITING

    Guri-si, Gyeonggi-do, 471-701, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seongnam-si, Gyeonggi-do, 13620, South Korea

  • Novartis Investigative Site

    RECRUITING

    Seoul, Seoul, 03080, South Korea

  • Novartis Investigative Site

    RECRUITING

    Girona, Catalonia, 17007, Spain

  • Novartis Investigative Site

    RECRUITING

    Taipei, 116081, Taiwan

  • University of Iowa Hospitals and Clinics

    RECRUITING

    Iowa City, Iowa, 52242, United States

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