Status:
NOT_YET_RECRUITING
Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease
Lead Sponsor:
ADARx Pharmaceuticals, Inc.
Conditions:
IgAN
C3G
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- Mean eGFR
- Clinical evidence of active kidney disease
- Been on supportive care
- vaccine requirements
- Females must not be pregnant or breastfeeding
- Men must agree to use acceptable contraception and not donate sperm
- IgAN: confirmed disease by kidney biopsy performed within 60 months prior to screening
- C3G/IC-MPGN: confirmed disease by kidney biopsy performed within 18 months prior to screening
Exclusion
- 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
- Liver dysfunction
- No donating blood
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06989359
Start Date
July 1 2025
End Date
July 1 2028
Last Update
June 10 2025
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