Kidney DiseasesPhase 3NCT06858319
Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.
A Phase 3 study testing zigakibart in people with Kidney Diseases and Kidney Diseases, Chronic, run by Novartis Pharmaceuticals at 26 sites in 9 countries.
Trial summary
The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Kidney Diseases, Kidney Diseases, Chronic, Urological Diseases
- What is being tested?
- zigakibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 26 sitesin 9 countries
- Study dates
- 28 Jul 2025to 25 Jun 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained prior to participation in the OLE study.
- Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol.
- Per Investigator's clinical judgment, the participant may benefit from receiving open-label treatment of zigakibart 600 mg s.c. Q2W.
Who cannot join
- Participants who prematurely withdrew from zigakibart parent studies in IgAN for any reason.
- Participants who at the time of first study treatment administration in the OLE are receiving chronic dialysis (≥30 days) or who require kidney transplantation.
- Acute kidney injury (AKI), defined by AKIN criteria (Mehta et al 2007) within 4 weeks of first study treatment administration in the OLE study.
- 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.
- 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.
- 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.
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- 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.
- 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.
- 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).
- Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.
- 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.
- Confirmed IgG levels < 3 g/L prior to first study treatment administration in the OLE study.
- 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).
- 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.
Trial locations and contacts
26 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
Novartis Pharmaceuticals contact
26 sites in 9 countries
United States9 sites, 9 recruiting
- Recruiting
Knoxville Kidney Center Pllc
Brentwood, Tennessee, 37027-4528
George Newman
- Recruiting
NY Nephrology
Clifton Park, New York, 12065
+1 518 579 0017
Frank Cortazar
- Recruiting
Dallas Renal Group
Dallas, Texas, 75230
Phuong Truong
- Recruiting
Dallas Renal Group
Dallas, Texas, 75230
+1 214 697 7187
Irfan Agha
- Recruiting
Colorado Kidney Care Nephrology
Denver, Colorado, 80230
Laura Kooienga
- Recruiting
Nephro Asso North Illinois Indiana
Houston, Texas, 77024
Suneel Udani
- Recruiting
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Lama Noureddine
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Kristin Meliambro
- Recruiting
Nephrology Associates Of Central FL
Orlando, Florida, 32806
Arvind Madan
Argentina5 sites, 5 recruiting
- Recruiting
Novartis Investigative Site
Buenos Aires, Buenos Aires F.D., 1280
- Recruiting
Novartis Investigative Site
Caba, Buenos Aires, 3375
- Recruiting
Novartis Investigative Site
Catamarca, Catamarca Province, K4700BTM
- Recruiting
Novartis Investigative Site
La Plata, Buenos Aires, B1902COS
- Recruiting
Novartis Investigative Site
Santa Fe, S3000EPV
South Korea4 sites, 4 recruiting
- Recruiting
Novartis Investigative Site
Cheonan, Chungcheongnam-do, 330-721
- Recruiting
Novartis Investigative Site
Guri-si, Gyeonggi-do, 471-701
- Recruiting
Novartis Investigative Site
Seongnam-si, Gyeonggi-do, 13620
- Recruiting
Novartis Investigative Site
Seoul, Seoul, 03080
Australia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Gosford, New South Wales, 2250
- Recruiting
Novartis Investigative Site
Kogarah, New South Wales, 2217
Malaysia2 sites, 2 recruiting
- Recruiting
Novartis Investigative Site
Kuala Lumpur, 59100
- Recruiting
Novartis Investigative Site
Kuantan, Pahang, 25100
Canada1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Toronto, Ontario, M4C 5T2
Mexico1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Monterrey, Nuevo León, 64060
Spain1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Girona, Catalonia, 17007
Taiwan1 site, 1 recruiting
- Recruiting
Novartis Investigative Site
Taipei, 116081
About this study
Official title: A Multicenter Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Zigakibart in Adults With Primary IgA Nephropathy.
The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study.
Read the detailed description
This is a non-randomized, multicenter, open-label extension (OLE) study to Phase 3, randomized CHK02-02 (CFUB523A12301)-BEYOND clinical study, Phase 1/2 ADU-CL-19 (CFUB523A12103) clinical study, and any other Novartis-sponsored clinical study of zigakibart in IgAN.
- Conditions
- Kidney Diseases, Kidney Diseases, Chronic, Urological Diseases, Glomerulonephritis, Glomerular Disease, Glomerulonephritis, IGA
- Being tested
- zigakibart
- Keywords
- Urologic Diseases, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Male Urogenital Diseases, Glomerulonephritis, Nephritis, Autoimmune Diseases, Immune System Diseases, Kidney Diseases, Glomerulonephritis, IGA, Primary IgA / Immunoglobulin A nephropathy, eGFR, UPCR, UACR, FUB523
- Medical subject headings
- Kidney Diseases, Renal Insufficiency, Chronic, Urologic Diseases, Glomerulonephritis, Glomerulonephritis, IGA, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zigakibartDrug
Also called FUB523; BION-1301
solution for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| zigakibart | Experimental | Participants will receive zigakibart. Receives: Drug: zigakibart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events.
Number of participants with adverse events will be provided.
Measured: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment
Number of participants with serious adverse events.
Number of participants with serious adverse events will be provided.
Measured: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment
Number of participants with adverse events of special interest.
Number of participants with adverse events of special interest will be provided.
Measured: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment
Secondary outcomes (8)
Change in UPCR from Baseline to Week 48 and Week 96.
The change in the ratio of urine protein to urine creatinine (UPCR), based on 24-hour urine collection, from Baseline to Week 48 and to Week 96.
Measured: Baseline visit, Week 48 and Week 96.
Change in eGFR from Baseline to Week 96.
Estimated glomerular filtration rate (eGFR) will be calculated using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation. The change (difference) in eGFR between Baseline and Week 96 timepoints will then be calculated.
Measured: Baseline visit and Week 96.
Change in eGFR from BEYOND parent study Baseline to Week 96 of OLE study.
eGFR will be calculated using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation. The change (difference) in eGFR between Baseline in the BEYOND study and Week 96 in OLE study will then be calculated.
Measured: Baseline visit and Week 96.
Serum concentration values of zigakibart at scheduled visits.
Serum concentration values will be provided for the following scheduled visits: Day 1, Week 24 and Week 96.
Measured: Baseline visit, Week 24 and Week 96.
Change from baseline in Immunoglobulin (IgA, IgG and IgM) levels.
Immunoglobulin (IgA, IgG and IgM) levels will be assessed from samples collected at Week 2, Week 4, Week 24, Week 48, Week 72, Week 96, then every 24 weeks after Week 96 through EOT. The change (difference) in immunoglobulin levels between Baseline and the noted timepoints will then be calculated.
Measured: Baseline visit, Week 2, Week 4, Week 24, Week 48, Week 72, Week 96, then every 24 weeks after Week 96 through EOT.
Presence of circulating binding and neutralizing anti- drug antibodies (ADA/Nab).
Number of participants with circulating binding and neutralizing anti-drug antibodies (ADA/Nab) in blood will be provided at the following scheduled visits: Day 1, Week 24, Week 96.
Measured: Baseline visit, Week 24 and Week 96.
Number of participants with abnormal safety laboratory parameters.
Number of participants with abnormal safety laboratory parameters will be provided.
Measured: Date of first administration of study treatment to the date that study treatment is discontinued, assessed up to approximately 5 years.
Number of participants with abnormal vital sign measurements.
Number of participants with abnormal vital sign measurements will be provided.
Measured: Date of first administration of study treatment to the date that study treatment is discontinued, assessed up to approximately 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start28 Jul 2025
- Primary completion25 Jun 2031 (estimated)
- Study completion25 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858319
- Sponsor's protocol ID
- CFUB523A12302B
- Status last verified
- Aug 2026
- First submitted
- 21 Feb 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Zigakibart in Adults With Primary IgA Nephropathy.
- ClinicalTrials.gov ID
- NCT06858319
- Acronym / sponsor ID
- CFUB523A12302B
- Conditions
- Kidney Diseases, Kidney Diseases, Chronic, Urological Diseases, Glomerulonephritis, Glomerular Disease, Glomerulonephritis, IGA
- Keywords
- Urologic Diseases, Female Urogenital Diseases, Female Urogenital Diseases and Pregnancy Complications, Urogenital Diseases, Male Urogenital Diseases, Glomerulonephritis, Nephritis, Autoimmune Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2025 (actual)
- Primary completion
- 25 Jun 2031 (estimated)
- Study completion
- 25 Jun 2031 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study.
Detailed description
This is a non-randomized, multicenter, open-label extension (OLE) study to Phase 3, randomized CHK02-02 (CFUB523A12301)-BEYOND clinical study, Phase 1/2 ADU-CL-19 (CFUB523A12103) clinical study, and any other Novartis-sponsored clinical study of zigakibart in IgAN.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| zigakibart | Experimental | Drug: zigakibartParticipants will receive zigakibart. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Signed informed consent must be obtained prior to participation in the OLE study.
- Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol.
- Per Investigator's clinical judgment, the participant may benefit from receiving open-label treatment of zigakibart 600 mg s.c. Q2W.
Key exclusion criteria (23 listed)
- Participants who prematurely withdrew from zigakibart parent studies in IgAN for any reason.
- Participants who at the time of first study treatment administration in the OLE are receiving chronic dialysis (≥30 days) or who require kidney transplantation.
- Acute kidney injury (AKI), defined by AKIN criteria (Mehta et al 2007) within 4 weeks of first study treatment administration in the OLE study.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zigakibartAlso: FUB523; BION-1301solution for subcutaneous injection | Drug | zigakibart |
Primary outcome
Number of participants with adverse events.
Time frame: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment
Number of participants with adverse events will be provided.
Number of participants with serious adverse events.
Time frame: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment
Number of participants with serious adverse events will be provided.
Number of participants with adverse events of special interest.
Time frame: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment
Number of participants with adverse events of special interest will be provided.
8 secondary outcomes
Change in UPCR from Baseline to Week 48 and Week 96.
Time frame: Baseline visit, Week 48 and Week 96.
Change in eGFR from Baseline to Week 96.
Time frame: Baseline visit and Week 96.
Change in eGFR from BEYOND parent study Baseline to Week 96 of OLE study.
Time frame: Baseline visit and Week 96.
Serum concentration values of zigakibart at scheduled visits.
Time frame: Baseline visit, Week 24 and Week 96.
Change from baseline in Immunoglobulin (IgA, IgG and IgM) levels.
Time frame: Baseline visit, Week 2, Week 4, Week 24, Week 48, Week 72, Week 96, then every 24 weeks after Week 96 through EOT.
Presence of circulating binding and neutralizing anti- drug antibodies (ADA/Nab).
Time frame: Baseline visit, Week 24 and Week 96.
Number of participants with abnormal safety laboratory parameters.
Time frame: Date of first administration of study treatment to the date that study treatment is discontinued, assessed up to approximately 5 years.
Number of participants with abnormal vital sign measurements.
Time frame: Date of first administration of study treatment to the date that study treatment is discontinued, assessed up to approximately 5 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Novartis Pharmaceuticals contact
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
26 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing zigakibart in people with Kidney Diseases and Kidney Diseases, Chronic, run by Novartis Pharmaceuticals at 26 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Argentina, South Korea, Australia, Malaysia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novartis Pharmaceuticals (1-888-669-6682, novartis.email@novartis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events. (time frame: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.