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

Part of paid clinical trials in Miami, Florida.

Sponsor
argenx
Study ID
NCT07773727
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Immunoglobulin A Nephropathy (IgAN)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ARGX-121 — BIOLOGICAL
    Subcutaneous Injection of ARGX-121
  • Placebo — BIOLOGICAL
    Subcutaneous Injection of Placebo

Study Details

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.

Key Dates

First listed
Aug 19, 2026
Start date
Oct 15, 2026
Status verified
Aug 2026
Primary completion
Oct 29, 2029
Completion
Feb 18, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ARGX-121
    Participants will receive ARGX-121 in subcutaneous injections during the double blinded treatment period and active only treatment periods (Total of 52 weeks)
  • Placebo Comparator: Placebo followed by ARGX-121
    Participants receive placebo for the double-blinded period of 24 weeks, followed by subcutaneous injections of ARGX-121 during the active only treatment period of 28 weeks.

Primary Outcome Measure

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. [ Time Frame: Up to 24 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Bioresearch PartnersMiamiFlorida33127-
Nephrology Associates of South Miami PAMiamiFlorida33173-3456-
Kidney and Hypertension Specialists- VirginiaManassasVirginia20110-

Find similar trials in Miami, FL

By research site
Bioresearch Partners· Miami, FLNephrology Associates of South Miami PA· Miami, FLKidney and Hypertension Specialists- Virginia· Manassas, VA

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