RecruitingPhase 2NCT06989359
Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease
A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease
Sponsor
ADARx Pharmaceuticals, Inc.
Enrollment
45 participants
Start Date
Aug 28, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria8
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
DRUGADX-038 Dose Level 2
siRNA duplex oligonucleotide
DRUGADX-038 Dose Level 1
siRNA duplex oligonucleotide
Locations(25)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06989359
Related Trials
CD19/BCMA UCAR-T for B Cell-Related Autoimmune Disease
NCT075862671 location
Chinese Adults With Kidney Disease
NCT0752209910 locations
Study of Efficacy and Safety of Iptacopan in Participants With IC-MPGN
NCT05755386127 locations
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
NCT0481761887 locations
Study of Ravulizumab in Immunoglobulin A Nephropathy (IgAN)
NCT06291376267 locations