Overview
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
Inclusion Criteria:
- 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 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
- Liver dysfunction
- No donating blood