ADX-038 treatment for adults with complement-mediated kidney disease.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial gives adults with biopsy-confirmed complement-mediated kidney diseases one of two dose levels of ADX-038 and follows them for safety, kidney outcomes, and drug exposure/effects (PK/PD). Eligible participants must have clinical evidence of active disease, an eGFR ≥30 mL/min/1.73 m2, and be on guideline supportive care including ACE inhibitor or ARB when appropriate, while several conditions (prior complement inhibitors, transplant, active infection, abnormal liver tests) exclude enrollment. The protocol compares two dose levels to characterize tolerability, biological target engagement, and preliminary signs of kidney benefit. Study visits take place at ADARx Clinical Sites in South Florida with required vaccinations and routine monitoring for infections and lab abnormalities.

Why it matters

Who can join: the full rules

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

Where it's running

• ADARx Clinical Site
  Miami, Florida, United States Recruiting
• ADARx Clinical Site
  Iowa City, Iowa, United States Recruiting
• ADARx Clinical Site
  Shelby, Michigan, United States Recruiting
• ADARx Clinical Site
  Great Neck, New York, United States Recruiting
• ADARx Clinical Site
  Columbus, Ohio, United States Recruiting
• ADARx Clinical Site
  Dakota Dunes, South Dakota, United States Recruiting

Study contacts

• Study coordinator: Tracy Nguyen
• Email: info@adarx.com
• Phone: 877-232-7974

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.