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Clinical Trials in the USA / NCT07773727
Recruiting 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 USA tracker
Sponsor
argenx
Phase
Phase 2
Started
2026-11-05
Last updated
2026-10-27

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 (11)

FacilityCityRegionStatus
Amicis Research Center - Valencia Valencia California Recruiting
Bioresearch Partners Miami Florida Recruiting
Nephrology Associates of South Miami PA Miami Florida Recruiting
BioResearch Partner - Pembroke Pines Pembroke Pines Florida Recruiting
Michigan Kidney Consultants Pontiac Michigan Recruiting
Prolato Clinical Research Center Houston Texas Recruiting
Northwest Houston Arthritis Center - Houston Houston Texas Not Yet Recruiting
Utah Kidney Research Institute Salt Lake City Utah Recruiting
Kidney and Hypertension Specialists- Virginia Manassas Virginia Recruiting
Japanese Red Cross Fukuoka Hospital Fukuoka Fukuoka Recruiting
Sapporo City General Hospital Sapporo Hokkaidô Recruiting

More argenx trials in the USA

A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy Active, not 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 Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia Active, not recruiting
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease Recruiting
Evaluating Long-term Safety of Efgartigimod Administered Intravenously and Efgartigimod PH20 Administered Subcutaneously in Children With Generalized Myasthenia Gravis Enrolling by invitation

Other trials for the same condition

A Study to Assess the Effects of Zigakibart on IgA Nephropathy. Recruiting
A Study to Learn About the Effects of Felzartamab Infusions on Adults With Immunoglobulin A Nephropathy (IgAN) 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 the USA