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Clinical Trials in Japan / NCT07773727
Starting soon Phase 2

A Study to Evaluate the Effect of ARGX-121 on the Change in Proteinuria in Adult Participants With IgAN

NCT07773727 · tracked via the Priya Life Science Japan tracker
Sponsor
argenx
Phase
Phase 2
Started
2026-10-15
Last updated
2026-10-16

Condition(s) studied

Immunoglobulin A Nephropathy (IgAN)

Investigational drug(s) / intervention(s)

ARGX-121Placebo

ARGX-121: Subcutaneous Injection of ARGX-121

Placebo: Subcutaneous Injection of Placebo

Study summary

The study will assess how ARGX-121 affects immunoglobulin A nephropathy (IgAN) disease outcomes, such as renal function, how it is distributed and eliminated from the body, and how the immune system responds in adults with IgAN.

While in the study, participants will continue to receive their usual medical care and medications for IgA nephropathy, unless the study doctor confirms otherwise.

The study will include a double blinded period, followed by an active drug period, and conclude with a follow up period. The total study duration for participants will be approximately 72 weeks, with a maximum of 52 weeks on ARGX-121.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Males and females (not pregnant) * At least 18 years old * Clinically diagnosed with IgAN with biopsy confirmation Exclusion Criteria: * Diagnosis of another autoimmune disease or known medical condition that would interfere with accurate assessment of clinical systems of IgAN * Has secondary form of IgAN leading to IgA deposits * History of Malignancy * Active infection of concern * Recent Major surgery or organ transplant

Primary outcome measure(s)

  • Change in proteinuria from baseline to week 24 as measured by the log-transformed urine protein-to-creatinine ratio (UPCR) derived from 24-h urine collection. — Up to 24 weeks
    UPCR is urine protein-to-creatinine ratio

Trial sites (6)

FacilityCityRegionStatus
Bioresearch Partners Miami Florida
Nephrology Associates of South Miami PA Miami Florida
Michigan Kidney Consultants Pontiac Michigan
Northwest Houston Arthritis Center - Houston Houston Texas
Kidney and Hypertension Specialists- Virginia Manassas Virginia
Japanese Red Cross Fukuoka Hospital Fukuoka Fukuoka

More argenx trials in Japan

A Natural History Study in Participants With Congenital Myasthenic Syndromes (CMS) Due to Mutations in DOK7, MUSK, AGRN, or LRP4 Recruiting
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease. Recruiting
A Study to Assess Efficacy and Safety of Empasiprubart Versus IVIg in Adults With CIDP Recruiting
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis Recruiting
A Study to Assess the Long-term Safety and Efficacy of a Subcutaneous Formulation of Efgartigimod in Adults With Active Idiopathic Inflammatory Myopathy Enrolling by invitation

Other trials for the same condition

A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN) Recruiting
A Study to Assess the Effects of Zigakibart on IgA Nephropathy. Recruiting
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 NCT07773727 on ClinicalTrials.gov ↗ ← All trials in Japan