Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease
Phase 2 – studying effectiveness and dosage
Conditions:
IgAN
C3G
Complement-mediated Kidney Disease
IgA Nephropathy (IgAN)
IC-MPGN
Sponsor: ADARx Pharmaceuticals, Inc.
trial.available_in:
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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.
Who can participate
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