Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease

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.

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Key information

Conditions

IgAN Autoimmune Diseases C3G Complement-mediated Kidney Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA IC-MPGN IgA Nephropathy (IgAN) Immune System Diseases Kidney Diseases Male Urogenital Diseases Nephritis Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

ADARx Clinical Site, Liverpool, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADX-038 Dose Level 2

Drug

siRNA duplex oligonucleotide

ADX-038 Dose Level 1

Drug

siRNA duplex oligonucleotide

Primary outcomes

Evaluate the safety and tolerability of ADX-038

Time frame: Length of study - 36 months

Incidence and severity of TEAEs

Study contacts

Contact information is provided by the study sponsor or research team.

Tracy Nguyen

CONTACT

[email protected]

877-232-7974

Sponsors and collaborators

Lead sponsor

ADARx Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2025
Primary completion: 2028
Study completion: 2029
First posted: May 25, 2025
Registry last updated: Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting