Chinese Adults With Kidney Disease

April 30, 2026 updated by: ADARx Pharmaceuticals, Inc.

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

This is a Phase 2 study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics of ADX-038 in adults with complement-mediated kidney diseases. The study will enroll Chinese adults with IgA nephropathy, complement 3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study will evaluate ADX-038 administered alone (Part A) and in combination with telitacicept (Part B).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

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

  • China
      • Beijing, China, 100034
        • Recruiting
        • ADARx Clinical Site
      • Shandong, China
        • Not yet recruiting
        • ADARx Clinical Site
      • Shanghai, China
        • Not yet recruiting
        • ADARx Clinical Site
      • Shangxi, China
        • Not yet recruiting
        • ADARx Clinical Site
    • Guangdong
      • Shenzhen, Guangdong, China, 518100
        • Recruiting
        • ADARx Clinical Site
    • Guizhou
      • Guiyang, Guizhou, China
        • Recruiting
        • ADARx Clinical Site
    • Henan
      • Zhengzhou, Henan, China
        • Not yet recruiting
        • ADARx Clinical Site
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014000
        • Recruiting
        • ADARx Clinical Site
    • Jiangsu
      • Wuxi, Jiangsu, China, 214000
        • Recruiting
        • ADARx Clinical Site
    • Shandong
      • Yantai, Shandong, China, 264008
        • 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:

  • Previous kidney transplant or major solid organ transplant
  • Required renal replacement therapy for more than 72 hours
  • Rapidly progressive glomerular nephritis or acute kidney injury
  • History of recurrent invasive infection
  • Current or previous use of C5 or CFB inhibitors (such as eculizumab, ravulizumab or iptacopan)
  • Active TB, HIV or other systemic 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: Part A - ADX-038 Monotherapy
Drug: ADX-038
siRNA duplex oligonucleotide
Experimental: Part B - ADX-038 Combination Therapy
Drug: ADX-038
siRNA duplex oligonucleotide
Drug: Telitacicept
fusion protein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the safety and tolerability of ADX-038 as a monotherapy and in combination with telitacicept
Time Frame: Part A - 24 Months and Part B - 15 months
Evaluate the proportion of patients with treatment emergent adverse events (TEAEs) with ADX-038 and telitacicept versus those on ADX-038 alone.
Part A - 24 Months and Part B - 15 months

Collaborators and Investigators

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

Sponsor

ADARx Pharmaceuticals, Inc.

Investigators

  • Study Director: Donald Fong, MD, ADARx Pharmaceuticals

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 (Estimated)

July 23, 2026

Primary Completion (Estimated)

July 10, 2028

Study Completion (Estimated)

January 21, 2029

Study Registration Dates

First Submitted

February 27, 2026

First Submitted That Met QC Criteria

April 8, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADX-038-204

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

No

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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