Chinese Adults With 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).

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Key information

Conditions

Immunoglobulin A Nephropathy (IgAN) Autoimmune Diseases Complement 3 Glomerulopathy (C3G) Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Glomerulonephritis, IGA Glomerulonephritis, Membranoproliferative IC-MPGN 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, Shenzhen, Guangdong, China

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

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

Treatment and study plan

ADX-038

Drug

siRNA duplex oligonucleotide

Telitacicept

Drug

fusion protein

Primary outcomes

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.

Study contacts

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

Stephanie Leyva

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 Chinese Adults With Complement-Mediated Kidney Disease

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2029
First posted: Apr 13, 2026
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.

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