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Clinical Trials in the USA / NCT05852938
Active, not recruiting Phase 3

A Study of Zigakibart in Adults With IgA Nephropathy

NCT05852938 · tracked via the Priya Life Science USA tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2023-07-06
Last updated
2026-04-01

Condition(s) studied

IgA NephropathyImmunoglobulin A Nephropathy

Investigational drug(s) / intervention(s)

BION-1301Placebo

BION-1301: BION-1301 Pre-Filled Syringe (PFS) 600mg subcutaneous administration every 2 weeks for 104 weeks.

Placebo: Placebo - PFS subcutaneous administration every 2 weeks for 104 weeks.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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. 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. * Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for \> 14 days within 12 weeks prior to Screening. * Use of systemic immunosuppressant medications. * IgG levels \< 6 g/L at Screening. Other protocol-defined inclusion/exclusion criteria may apply

Primary outcome measure(s)

Trial sites (200)

FacilityCityRegionStatus
University of Alabama at Birmingham: The Kirklin Clinic Birmingham Alabama
Nephrology Consultants, LLC Huntsville Alabama
University of California, San Francisco San Francisco California
Valiance Clinical Research South Gate California
University of Colorado Hospital Aurora Colorado
Denver Nephrology Research Division Denver Colorado
Vida Medical Centers - Pembroke Pines Pembroke Pines Florida
NorthShore University HealthSystem Evanston Illinois
Nephrology Associales of Northern Illinois and Indiana Hinsdale Illinois
Nephrology Associates of Northern Illinois and Indiana - 7836 W Jefferson Blvd Fort Wayne Indiana
University Of Iowa Hospitals And Clinics Iowa City Iowa
Intermed Consultants Edina Minnesota
Capital District Renal Physicians Clifton Park New York
Nephrology Associates PC - Flushing Flushing New York
Icahn School of Medicine at Mount Sinai New York New York
University of Cincinnati College of Medicine - 231 Albert Sabin Way Cincinnati Ohio
Cleveland Clinic-9500 Euclid Ave Cleveland Ohio
OHSU - Oregon Clinical and Translational Research Institute Portland Oregon
Northeast Clinical Research Center, LLC Bethlehem Pennsylvania
Columbia Nephrology Associates , P.A. - Columbia Columbia South Carolina
Knoxville Kidney Center, PLLC - Frenova F1 Knoxville Tennessee
Dallas Renal Group - 1411 N Beckley Ave Dallas Texas
Dallas Renal Group - Waxachie - 2460 N. I-35 Dallas Texas
DaVita Clinical Research El Paso Texas
University of Texas MD Anderson Cancer Center-1155 Pressler Houston Texas
East Texas Nephrology Associates Lufkin Texas
Nephrology Associates of Northern Virginia-8501 Arlington Blvd Fairfax Virginia
Swedish Center for Comprehensive Care Seattle Washington
Novartis Investigative Site La Plata Buenos Aires
Novartis Investigative Site Catamarca Catamarca Province
Novartis Investigative Site Barracas Ciudad Autónoma de BuenosAires
Novartis Investigative Site Rosario Santa Fe Province
Novartis Investigative Site Santa Fe Santa Fe Province
Novartis Investigative Site Buenos Aires Argentina
Novartis Investigative Site Gosford New South Wales
Novartis Investigative Site Kogarah New South Wales
Novartis Investigative Site Liverpool New South Wales
Novartis Investigative Site Penrith New South Wales
Novartis Investigative Site St Leonards New South Wales
Novartis Investigative Site Cairns North Queensland

+ 160 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05852938 on ClinicalTrials.gov ↗ ← All trials in the USA