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

A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease

Phase 2 Interventional ADARx Pharmaceuticals, Inc. · NCT06989359

This trial will test whether ADX-038 is safe and helps adults with complement-mediated kidney diseases such as IgA nephropathy, C3G, and IC-MPGN.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment45 (estimated)
Ages18 Years and up
SexAll
SponsorADARx Pharmaceuticals, Inc. Industry-sponsored
Locations25 sites (Doral, Florida and 24 other locations)
Trial IDNCT06989359 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with biopsy-confirmed IgA nephropathy, C3 glomerulopathy, or IC-MPGN who have active disease, an eGFR ≥30 mL/min/1.73 m2, and are on standard supportive care (ACE inhibitor/ARB when applicable) are the intended candidates.

Not a fit: Patients with hereditary or acquired complement deficiency, prior complement inhibitor treatment, a kidney transplant or dialysis dependence, active systemic infection, or significant liver test abnormalities are unlikely to benefit or are excluded from participation.

Why it matters

Potential benefit: If successful, ADX-038 could reduce complement-driven kidney inflammation and slow loss of kidney function in affected patients.

How similar studies have performed: Other drugs that target the complement system have shown promising signals in related kidney diseases, but complement-targeting approaches are still being actively studied and are not yet definitive.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Doral, Florida and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions IgANC3GComplement-mediated Kidney DiseaseIgA NephropathyIC-MPGNcomplement-mediated kidney disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.