How ARGX-121 affects protein in IgA nephropathy
Official title: A Phase 2, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ARGX-121 SC in Adult Participants With Primary IgA Nephropathy
Run by argenx · NCT07773727 · Data updated 2026-11-12
This study tests whether ARGX-121 can change protein in urine and other kidney outcomes in adults with IgA nephropathy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | argenx Industry-sponsored |
| Locations | 11 sites (Valencia, California and 10 other locations) |
| Status | Recruiting |
| Started | November 5, 2026 |
| Main results expected | October 29, 2029 |
| Study ends | February 18, 2030 |
| Registry record updated | October 27, 2026 |
| Trial ID | NCT07773727 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with biopsy-confirmed IgA nephropathy, not pregnant, without active autoimmune diseases or recent major surgeries that could interfere with assessment.
✕Probably not a fit
Patients with other autoimmune conditions, secondary IgA nephropathy, history of malignancy, active infections, or recent major surgery may not benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 2, randomized, double-blind study compares ARGX-121 to placebo in adults with biopsy-confirmed IgA nephropathy. Participants will continue standard care while receiving ARGX-121 or placebo for up to 52 weeks, followed by an observation period, for a total duration of about 72 weeks. The trial will measure kidney-related outcomes, how the drug behaves in the body, and immune responses to IgA nephropathy. The study includes a blinded period, an active-treatment period, and a follow-up phase to assess safety and potential efficacy signals. Locations include sites in California and Florida under lead sponsor argenx.
Why it matters
Potential benefit: If successful, ARGX-121 could improve kidney outcomes and slow disease progression in IgA nephropathy.
How similar studies have gone: Previous studies of targeted therapies in IgA nephropathy have shown potential signals, but this approach is being investigated in a Phase 2 setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Amicis Research Center - Valencia
Valencia, California, United States Recruiting -
Bioresearch Partners
Miami, Florida, United States Recruiting -
Nephrology Associates of South Miami PA
Miami, Florida, United States Recruiting -
BioResearch Partner - Pembroke Pines
Pembroke Pines, Florida, United States Recruiting -
Michigan Kidney Consultants
Pontiac, Michigan, United States Recruiting -
Prolato Clinical Research Center
Houston, Texas, United States Recruiting
Show 5 more locations
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Utah Kidney Research Institute
Salt Lake City, Utah, United States Recruiting -
Kidney and Hypertension Specialists- Virginia
Manassas, Virginia, United States Recruiting -
Japanese Red Cross Fukuoka Hospital
Fukuoka, Fukuoka, Japan Recruiting -
Sapporo City General Hospital
Sapporo, Hokkaidô, Japan Recruiting -
Northwest Houston Arthritis Center - Houston
Houston, Texas, United States Not yet recruiting
Study contacts
- Study coordinator: Sabine Coppieters, MD
- Email: Clinicaltrials@argenx.com
- Phone: 857-350-4834
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
ADX-038 with or without telitacicept for Chinese adults with IgA nephropathy, C3G, or IC-MPGN
This Phase 2 trial will test whether ADX-038, given alone or with telitacicept, is safe and helps Chinese adults with biopsy-confirmed IgA nephropathy, complement 3 glomerulopathy, or immune complex MPGN.
-
Zigakibart treatment for IgA nephropathy
This trial will test whether the drug zigakibart can slow disease progression in people with biopsy-confirmed IgA nephropathy and persistent proteinuria.
-
Effects of Felzartamab on Adults with Immunoglobulin A Nephropathy
This study is testing if felzartamab infusions can help adults with immunoglobulin A nephropathy reduce protein in their urine and improve kidney function.
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.