Chinese Adults With Kidney Disease
A Phase 2 Study to Assess ADX-038 in Chinese Adults With Complement-Mediated Kidney Disease
1 other identifier
interventional
30
1 country
10
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2026
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2026
CompletedFirst Posted
Study publicly available on registry
April 13, 2026
CompletedStudy Start
First participant enrolled
July 23, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
July 10, 2028
Study Completion
Last participant's last visit for all outcomes
January 21, 2029
May 1, 2026
April 1, 2026
2 years
February 27, 2026
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluate the safety and tolerability of ADX-038 as a monotherapy and in combination with telitacicept
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
Study Arms (2)
Part A - ADX-038 Monotherapy
EXPERIMENTALPart B - ADX-038 Combination Therapy
EXPERIMENTALInterventions
siRNA duplex oligonucleotide
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
ADARx Clinical Site
Shenzhen, Guangdong, 518100, China
ADARx Clinical Site
Guiyang, Guizhou, China
ADARx Clinical Site
Zhengzhou, Henan, China
ADARx Clinical Site
Baotou, Inner Mongolia, 014000, China
ADARx Clinical Site
Wuxi, Jiangsu, 214000, China
ADARx Clinical Site
Yantai, Shandong, 264008, China
ADARx Clinical Site
Beijing, 100034, China
ADARx Clinical Site
Shandong, China
ADARx Clinical Site
Shanghai, China
ADARx Clinical Site
Shangxi, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Donald Fong, MD
ADARx Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2026
First Posted
April 13, 2026
Study Start (Estimated)
July 23, 2026
Primary Completion (Estimated)
July 10, 2028
Study Completion (Estimated)
January 21, 2029
Last Updated
May 1, 2026
Record last verified: 2026-04