A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 18 Years or Older With Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)
Primary Objective
To evaluate the safety, clinical activity, plasma PK, and local and systemic PD effects of ADX-097 when administered to participants with IgAN, LN, or C3G.
Description
Phase 2 study to evaluated the ADX-097 in patients with IgAN, LN, or C3G over the period of 6 months.
Details
Age
Adult
Eligibility
Older than 18, >0.75g/24 hours or uPCR > 0.5g/g, Screening eGFR >= 30mL/min/1.73m^2, up to date on vaccines, and stable on RAAS inhibitor or SGLT2 inhibitor for 12 weeks prior to study day 1.
Locations
Childrens Hospital Colorado
University of Colorado Hospital
Principal Investigator
Bradley Dixon
Study ID
Protocol Number: 24-0590
More information available at ClinicalTrials.gov: NCT06419205
Is this Study for You?
Not finding the right Study for you? Join ResearchMatch, a nation-wide registry connecting volunteers and researchers