RecruitingPhase 2NCT07522099

Chinese Adults With Kidney Disease

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


Sponsor

ADARx Pharmaceuticals, Inc.

Enrollment

30 participants

Start Date

Jul 23, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

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Interventions

DRUGADX-038

siRNA duplex oligonucleotide

DRUGTelitacicept

fusion protein


Locations(10)

ADARx Clinical Site

Shenzhen, Guangdong, China

ADARx Clinical Site

Guiyang, Guizhou, China

ADARx Clinical Site

Zhengzhou, Henan, China

ADARx Clinical Site

Baotou, Inner Mongolia, China

ADARx Clinical Site

Wuxi, Jiangsu, China

ADARx Clinical Site

Yantai, Shandong, China

ADARx Clinical Site

Beijing, China

ADARx Clinical Site

Shandong, China

ADARx Clinical Site

Shanghai, China

ADARx Clinical Site

Shangxi, China

View Full Details on ClinicalTrials.gov

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NCT07522099


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