A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease
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.
CT.gov Identifier
EudraCT Identifier
N/A
CTIS:
N/A
Sponsor
ADARx Pharmaceuticals
Collaborator
N/A
Study Contact Information
Recruiting
Study Details
Diseases
Glomerulonephritis and atypical hemolytic uremic syndrome (aHUS)
Atypical Hemolytic Uremic Syndrome; C3 Glomerulopathy; Complement Factor H Deficiency
IgA nephropathy
Study Drug
ADX-038
Genes
CFI
CFH
Study Dates
Aug 2025 - Dec 2028
Sex
Female & Male
Age
18+ years
Inclusion and Exclusion Criteria
Inclusion Criteria:
- Mean eGFR greater than or equal to 30 mL/min/1.73m2Clinical evidence of active kidney diseaseTreated with supportive care including an ACE inhibitor or ARB if applicableWilling to receive required vaccinationsPrimary diagnosis of IgAN, C3G or IC-MPGN confirmed by a kidney biopsy
Exclusion Criteria:
- Hereditary or acquired complement deficiencyKidney transplant or renal replacement therapyHistory of solid organ transplantOther kidney diseaseHistory of recurrent invasive infectionsReceived complement inhibitor treatmentsActive systemic viral, bacterial, or fungal infectionAbnormal liver function
Protocol 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.
Study Locations
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