Treatment of IgA Nephropathy with Zigakibart
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)
Run by Chinook Therapeutics, Inc. · NCT05852938 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if a new treatment called BION-1301 can help adults with IgA nephropathy reduce protein in their urine and improve their kidney health.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 292 (estimated) |
| Sponsor | Chinook Therapeutics, Inc. Industry-sponsored |
| Locations | 181 sites (Birmingham, Alabama and 180 other locations) |
| Trial ID | NCT05852938 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with biopsy-proven IgA nephropathy and specific kidney function criteria.
✕Probably not a fit
Patients with IgA nephropathy due to secondary causes or with eGFR below 20 mL/min/1.73m² may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and efficacy of BION-1301 in adults diagnosed with IgA nephropathy. Approximately 272 participants will be randomized to receive either BION-1301 or a placebo for a duration of 104 weeks, with assessments of safety and efficacy conducted over 2.5 years. An exploratory cohort of 20 additional participants with lower eGFR will also be included to gather further insights. The primary focus is to determine the effect of BION-1301 on reducing proteinuria in these patients.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce proteinuria and improve kidney function in patients with IgA nephropathy.
How similar studies have gone: Other studies have shown promise in treating IgA nephropathy with similar approaches, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female participants aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures. * Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Sponsor. * eGFR ≥ 30 mL/min/1.73m\^2 at Screening based on the 2021 CKD-EPI equation. * Total urine protein ≥ 1.0 g/day or UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory. * Stable on a maximally tolerated dose of angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) for at least 12 weeks prior to Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated dose of sodium glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERAs) and/or mineralocorticoid receptor antagonists (MRAs) for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on a stable dose of ACEi, ARB, SGLT2i, ERAs, and/or MRAs for the duration of the study. * Screening weight of 45 to 150 kg. * Men and women of childbearing potential (WOCBP; per Clinical Trials Facilitation and Coordination Group \[CTFG\] 2020) must agree to follow protocol-specified contraception guidance from Screening through approximately 5 half-lives (24 weeks) after the final dose of study drug. Use of hormonal contraceptive agents must have been initiated \> 1 month prior to first dose of study drug. * Provide written informed consent and be willing to comply with study visits and procedures. Exclusion Criteria: * Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias. * Diagnosis of IgA Vasculitis. * Current or history of nephrotic syndrome. * Average blood pressure \> 150/90 mm Hg (systolic/diastolic) from 3 readings obtained at the initial Screening visit. If blood pressure is too high, the 3 readings may be repeated once within the Screening period if clinically appropriate as per the Investigator. * Clinical suspicion of IgAN with rapidly progressive glomerulonephritis (RPGN) based on KDIGO guidelines * Chronic Kidney Disease, either clinically suspected or based on biopsy, resulting from any condition or another glomerulopathy/podocytopathy other than IgAN. * History of Type 1 Diabetes. * Participants with Type 2 diabetes are excluded if any of the following are present: * Screening HbA1c (glycated hemoglobin) of \> 8%. * Evidence of diabetic changes on kidney biopsy, performed for any reason. * History of diabetic microvascular disease (retinopathy, neuropathy, nephropathy) and/or macrovascular disease (atherosclerotic heart disease, peripheral vascular disease, cerebrovascular disease). * Unstable anti-diabetic regimen: * Prior exposure to any antibody directed against APRIL. * History of a previous severe allergic reaction with generalized urticaria, angioedema, or anaphylaxis, including a history of allergy or hypersensitivity to any component of BION-1301, or history of severe hypersensitivity reaction to any monoclonal antibody. * Received an investigational new drug within 28 days or 5 half-lives, whichever is longer, prior to Screening. * Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for \> 14 days within 12 weeks prior to Screening. * Use of systemic immunosuppressant medications. * Any confirmed or suspected immunosuppressive or immune-deficient state, including but not limited to common variable immunodeficiency (CVID), HIV infection or asplenia, history of bone marrow or organ transplantation with exception of corneal transplants. * Current severe infection requiring antimicrobials or history of recurrent, severe, infections as determined by the Investigator. * Positive serology test 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 be allowed), or antibodies to HIV-1 and/or HIV-2 at Screening. * Received a live vaccination within 12 weeks prior to Screening or plan to have a live vaccination within 6 months after the last dose of study drug. * History of malignancy unless cancer free for at least 5 years or non-melanoma skin cancer that was completely resected. A participant with curatively treated cervical carcinoma in situ is eligible for the study. Participants with low-risk prostate cancer (i.e., Gleason score \< 7 and prostate specific antigen \< 10 ng/mL) are allowed. * 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 disorder, condition, disease, or laboratory finding that, in the Investigator's assessment, would place the participant at unacceptable risk, limit compliance with study requirements, or confound interpretation of study results. * IgG levels \< 6 g/L at Screening. * Participation in another interventional trial with an investigational agent/device is prohibited during the course of this study.
Where it's running
-
University of Alabama at Birmingham: The Kirklin Clinic
Birmingham, Alabama, United States Recruiting -
Nephrology Consultants, LLC
Huntsville, Alabama, United States Recruiting -
IMD Clinical Trials
Huntington Park, California, United States Recruiting -
Valiance Clinical Research
S. Gate, California, United States Recruiting -
University of California, San Francisco
San Francisco, California, United States Recruiting -
University of Colorado Hospital
Aurora, Colorado, United States Recruiting
Show 44 more locations
-
Denver Nephrology Research Division
Denver, Colorado, United States Recruiting -
Vida Medical Centers - Pembroke Pines
Pembroke Pines, Florida, United States Recruiting -
NorthShore University HealthSystem
Evanston, Illinois, United States Recruiting -
Nephrology Associales of Northern Illinois and Indiana
Hinsdale, Illinois, United States Recruiting -
Nephrology Associates of Northern Illinois and Indiana - 7836 W Jefferson Blvd
Fort Wayne, Indiana, United States Recruiting -
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, United States Recruiting -
Intermed Consultants
Edina, Minnesota, United States Recruiting -
Capital District Renal Physicians
Clifton Park, New York, United States Recruiting -
Nephrology Associates PC - Flushing
Flushing, New York, United States Recruiting -
Icahn School of Medicine at Mount Sinai
New York, New York, United States Recruiting -
University of Cincinnati College of Medicine - 231 Albert Sabin Way
Cincinnati, Ohio, United States Recruiting -
Cleveland Clinic-9500 Euclid Ave
Cleveland, Ohio, United States Recruiting -
OHSU - Oregon Clinical and Translational Research Institute
Portland, Oregon, United States Recruiting -
Northeast Clinical Research Center, LLC
Bethlehem, Pennsylvania, United States Recruiting -
Columbia Nephrology Associates , P.A. - Columbia
Columbia, South Carolina, United States Recruiting -
Knoxville Kidney Center, PLLC - Frenova F1
Knoxville, Tennessee, United States Recruiting -
Dallas Renal Group - 1411 N Beckley Ave
Dallas, Texas, United States Recruiting -
Dallas Renal Group - Waxachie - 2460 N. I-35
Dallas, Texas, United States Recruiting -
DaVita Clinical Research
El Paso, Texas, United States Recruiting -
University of Texas MD Anderson Cancer Center-1155 Pressler
Houston, Texas, United States Recruiting -
East Texas Nephrology Associates
Lufkin, Texas, United States Recruiting -
Nephrology Associates of Northern Virginia-8501 Arlington Blvd
Fairfax, Virginia, United States Recruiting -
Swedish Center for Comprehensive Care
Seattle, Washington, United States Recruiting -
Novartis Investigative Site
La Plata, Buenos Aires, Argentina Recruiting -
Novartis Investigative Site
San Fernando del Valle de Catamarca, Catamarca, Argentina Recruiting -
Novartis Investigative Site
Barracas, Ciudad Autónoma De BuenosAires, Argentina Recruiting -
Novartis Investigative Site
Rosario, Santa Fe, Argentina Recruiting -
Novartis Investigative Site
Ciudad Autónoma de Buenos Aires, Argentina Recruiting -
Novartis Investigative Site
Santa Fe, Argentina Recruiting -
Novartis Investigative Site
Gosford, New South Wales, Australia Recruiting -
Novartis Investigative Site
Kogarah, New South Wales, Australia Recruiting -
Novartis Investigative Site
Liverpool, New South Wales, Australia Recruiting -
Novartis Investigative Site
Penrith, New South Wales, Australia Recruiting -
Novartis Investigative Site
Cairns North, Queensland, Australia Recruiting -
Novartis Investigative Site
Box Hill, Victoria, Australia Recruiting -
Novartis Investigative Site
St Albans, Victoria, Australia Recruiting -
Novartis Investigative Site
Bonheiden, Antwerpen, Belgium Recruiting -
Novartis Investigative Site
Gent, Oost-Vlaanderen, Belgium Recruiting -
Novartis Investigative Site
Roeselare, West-Vlaanderen, Belgium Recruiting -
Novartis Investigative Site
Liège, Belgium Recruiting -
Novartis Investigative Site
Lodelinsart, Belgium Recruiting -
Novartis Investigative Site
Woluwe-Saint-Lambert, Belgium Recruiting -
Novartis Investigative Site
Santana, Amapá, Brazil Recruiting -
Novartis Investigative Site
Belo Horizonte, Minas Gerais, Brazil Recruiting
+131 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Novartis Pharmaceuticals
- Email: novartis.email@novartis.com
- Phone: 1-888-669-6682
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Atrasentan for pediatric primary IgA nephropathy
This study tests whether atrasentan can help children and teens with primary IgA nephropathy reduce protein in urine.
-
JADE101 in IgA Nephropathy: a Phase 2 test in adults
This Phase 2 open-label study tests JADE101 in adults with IgA nephropathy to see how safe it is and how well it works when added to standard care.
-
MIL116 for people with IgA nephropathy and healthy volunteers
This trial will test whether subcutaneous MIL116, an anti‑APRIL antibody, is safe and how it behaves in the body in adults with IgA nephropathy and in healthy volunteers.
-
Anti-CD19/BCMA universal CAR-T (RD06-05) for autoimmune diseases
This early-phase test gives a universal CAR-T therapy (RD06-05) that targets CD19 and BCMA to adults with autoimmune diseases such as SLE/lupus nephritis, ANCA-associated vasculitis, and anti-GBM disease.
-
BHV-1400 for IgA nephropathy
This study will try BHV-1400 in adults with biopsy-confirmed IgA nephropathy to see if the drug is safe and tolerable.
-
Nefecon (budesonide) plus ambrisentan for IgA nephropathy with proteinuria
This test will see if combining Nefecon (a gut‑targeted budesonide) with ambrisentan can reduce urine protein and slow kidney decline in adults with IgA nephropathy who have at least 0.5 g of protein in a 24‑hour urine collection.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.