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A Study of Zigakibart in Adults With IgA Nephropathy | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

A Study of Zigakibart in Adults With IgA Nephropathy

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of BION-1301 in Adults With IgA Nephropathy (The BEYOND Study)

NCT05852938•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy

Detailed Description

Approximately 330 participants with eGFR ≥ 30 mL/min/1.73m\^2 and with biopsy-proven IgAN will be randomized to receive 600 mg Q2W BION-1301 or a matched placebo for 104 weeks. An additional exploratory cohort, not included in the primary analysis, will be comprised of approximately 20 participants (10 participants per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20 to \< 30 mL/min/1.73 m\^2. The exploratory cohort will be randomized using the same schema as the primary cohort. The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on proteinuria in adults with IgA nephropathy. Participants will have assessments of safety and efficacy for up to 2.5 years (134 weeks). To facilitate study participation over this time period, other visits may be remote (away from study site) for participants who elect to self-administer the study drug.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+16 more criteria

Locations (200)

University of Alabama at Birmingham: The Kirklin Clinic

Birmingham, Alabama, United States

Nephrology Consultants, LLC

Huntsville, Alabama, United States

University of California, San Francisco

San Francisco, California, United States

Valiance Clinical Research

South Gate, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

Denver Nephrology Research Division

Denver, Colorado, United States

Vida Medical Centers - Pembroke Pines

Pembroke Pines, Florida, United States

NorthShore University HealthSystem

Evanston, Illinois, United States

Nephrology Associales of Northern Illinois and Indiana

Hinsdale, Illinois, United States

Nephrology Associates of Northern Illinois and Indiana - 7836 W Jefferson Blvd

Fort Wayne, Indiana, United States

Key Dates

Start Date

July 6, 2023

Primary Completion Date

February 19, 2026

Completion Date

June 7, 2028

Last Updated

December 12, 2025

Enrollment

383

ACTUAL participants

Conditions

IgA NephropathyImmunoglobulin A Nephropathy

Interventions

BION-1301

DRUG

Placebo

DRUG

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

NCT06291376

Immunoglobulin A NephropathyIgAN

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RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression

NCT05797610

Primary IgA Nephropathy

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Zigakibart in Adults With IgA Nephropathy

Inclusion Criteria

Exclusion Criteria

Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)

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