Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease

Purpose

This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.

Conditions

  • IgAN
  • C3G
  • Complement-mediated Kidney Disease
  • IgA Nephropathy (IgAN)
  • IC-MPGN

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Mean eGFR greater than or equal to 30 mL/min/1.73m2 - Clinical evidence of active kidney disease - Treated with supportive care including an ACE inhibitor or ARB if applicable - Willing to receive required vaccinations - Primary diagnosis of IgAN, C3G or IC-MPGN confirmed by a kidney biopsy

Exclusion Criteria

  • Hereditary or acquired complement deficiency - Kidney transplant or renal replacement therapy - History of solid organ transplant - Other kidney disease - History of recurrent invasive infections - Received complement inhibitor treatments - Active systemic viral, bacterial, or fungal infection - Abnormal liver function

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ADX-038 Dose Level 1 - IgAN
  • Drug: ADX-038 Dose Level 1
    siRNA duplex oligonucleotide
Experimental
ADX-038 Dose Level 1 - C3G
  • Drug: ADX-038 Dose Level 1
    siRNA duplex oligonucleotide
Experimental
ADX-038 Dose Level 2 - IgAN
  • Drug: ADX-038 Dose Level 2
    siRNA duplex oligonucleotide

Recruiting Locations

ADARx Clinical Site
Doral, Florida 33122

ADARx Clinical Site
Miami, Florida 33127

ADARx Clinical Site
Pembroke Pines, Florida 33029

ADARx Clinical Site
Iowa City, Iowa 52242

ADARx Clinical Site
Shreveport, Louisiana 71101

ADARx Clinical Site
Shelby, Michigan 48315

ADARx Clinical Site
Great Neck, New York 11021

ADARx Clinical Site
Columbus, Ohio 43210

ADARx Clinical Site
Dakota Dunes, South Dakota 57049

ADARx Clinical Site
Dallas, Texas 75230

ADARx Clinical Site
Houston, Texas 77027

More Details

NCT ID
NCT06989359
Status
Recruiting
Sponsor
ADARx Pharmaceuticals, Inc.

Study Contact

Lyle Gee
877-232-7974
lgee@adarx.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center