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

June 4, 2026 updated by: ADARx Pharmaceuticals, Inc.

A Phase 2 Study to Assess ADX-038 in Participants With 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
      • Sydney, Australia, NSW 2139
        • Recruiting
        • ADARx Clinical Site
      • Woolloongabba, Australia, QLD 4102
        • Recruiting
        • ADARx Clinical Site
    • New South Wales
      • Liverpool, New South Wales, Australia, 2170
        • Recruiting
        • ADARx Clinical Site
      • Wollongong, New South Wales, Australia, 2500
        • Recruiting
        • ADARx Clinical Site
  • Hong Kong
      • Hong Kong, Hong Kong, 2500
        • Recruiting
        • ADARx Clinical Site
      • Shatin, Hong Kong
        • Recruiting
        • ADARx Clinical Site
  • South Korea
      • Cheonan, South Korea, 31151
        • Recruiting
        • ADARx Clinical Site
      • Daegu, South Korea, 42601
        • Recruiting
        • ADARx Clinical Site
      • Gyeonggi-do, South Korea, 05278
        • Recruiting
        • ADARx Clinical Site
      • Seoul, South Korea, 03722
        • Recruiting
        • ADARx Clinical Site
      • Seoul, South Korea, 02841
        • Recruiting
        • ADARx Clinical Site
      • Seoul, South Korea, 03080
        • Recruiting
        • ADARx Clinical Site
      • Seoul, South Korea, 05278
        • Recruiting
        • ADARx Clinical Site
    • Gangwon-do
      • Wŏnju, Gangwon-do, South Korea, 26426
        • Recruiting
        • ADARx Clinical Site
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • ADARx Clinical Site
      • Madrid, Spain, 28041
        • Recruiting
        • ADARx Clinical Site
      • Seville, Spain, 41009
        • Recruiting
        • ADARx Clinical Site
  • United Kingdom
      • Newcastle upon Tyne, United Kingdom, UK, NE7 7DN
        • Recruiting
        • ADARx Clinical Site
  • United States
    • Florida
      • Doral, Florida, United States, 33122
        • Recruiting
        • ADARx Clinical Site
      • Miami, Florida, United States, 33127
        • Recruiting
        • ADARx Clinical Site
      • Pembroke Pines, Florida, United States, 33029
        • Recruiting
        • ADARx Clinical Site
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • ADARx Clinical Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71101
        • Recruiting
        • ADARx Clinical Site
    • Michigan
      • Shelby, Michigan, United States, 48315
        • Recruiting
        • ADARx Clinical Site
    • New York
      • Great Neck, New York, United States, 11021
        • Recruiting
        • ADARx Clinical Site
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • ADARx Clinical Site
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Recruiting
        • ADARx Clinical Site
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • ADARx Clinical Site
      • Houston, Texas, United States, 77027
        • Recruiting
        • ADARx Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ADX-038 Dose Level 1 - IgAN
Drug: ADX-038 Dose Level 1
siRNA duplex oligonucleotide
Experimental: ADX-038 Dose Level 1 - C3G
Drug: ADX-038 Dose Level 1
siRNA duplex oligonucleotide
Experimental: ADX-038 Dose Level 2 - IgAN
Drug: ADX-038 Dose Level 2
siRNA duplex oligonucleotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety and tolerability of ADX-038
Time Frame: Length of study - 36 months
Incidence and severity of TEAEs
Length of study - 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ADARx Pharmaceuticals, Inc.

Investigators

  • Study Director: Aditya Patel, MD, ADARx Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

May 22, 2025

First Submitted That Met QC Criteria

May 22, 2025

First Posted (Actual)

May 25, 2025

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADX-038-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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