Recruiting
Phase 2

ADX-038

Sponsor:

ADARx Pharmaceuticals, Inc.

Code:

NCT06989359

Conditions

IgAN

C3G

Complement-mediated Kidney Disease

IgA Nephropathy (IgAN)

IC-MPGN

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ADX-038 Dose Level 2

ADX-038 Dose Level 1

Study Details

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.

Conditions

IgAN

C3G

Complement-mediated Kidney Disease

IgA Nephropathy (IgAN)

IC-MPGN

Study ID

NCT06989359

Start date

Aug 28, 2025

Status verified date

Sep, 2026

Completion date

Jun, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

45 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ADX-038 Dose Level 1 - IgAN

experimental: ADX-038 Dose Level 1 - C3G

experimental: ADX-038 Dose Level 2 - IgAN

Interventions

ADX-038 Dose Level 2

siRNA duplex oligonucleotide

ADX-038 Dose Level 1

siRNA duplex oligonucleotide

Primary outcome measure

  • Evaluate the safety and tolerability of ADX-038 [ Time Frame: Length of study - 36 months ]

Central Contacts and Locations

Central contacts

Tracy Nguyen

877-232-7974info@adarx.com

Locations

ADARx Clinical Site

Recruiting

Miami, Florida, United States, 33127

ADARx Clinical Site

Recruiting

Iowa City, Iowa, United States, 52242

ADARx Clinical Site

Recruiting

Shreveport, Louisiana, United States, 71101

ADARx Clinical Site

Recruiting

Shelby, Michigan, United States, 48315

ADARx Clinical Site

Recruiting

Great Neck, New York, United States, 11021

ADARx Clinical Site

Recruiting

Columbus, Ohio, United States, 43210

ADARx Clinical Site

Recruiting

Dakota Dunes, South Dakota, United States, 57049

ADARx Clinical Site

Recruiting

Houston, Texas, United States, 77027

More Information

Sponsor

ADARx Pharmaceuticals, Inc.

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • IgA Nephropathy
  • IgAN
  • C3G
  • IC-MPGN
  • complement-mediated kidney disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by ADARx Pharmaceuticals, Inc. on 2026-09-03.