Chinese Adults With Kidney Disease

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07522099

Enrollment

Registered

2026-04-13

Start date

2026-05-21

Completion date

2029-01-21

Last updated

2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complement 3 Glomerulopathy (C3G), IC-MPGN, Immunoglobulin A Nephropathy (IgAN)

Keywords

IgAN, C3G, IC-MPGN, complement mediated kidney diseases, IgA Nephropathy

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).

Interventions

DRUGADX-038

siRNA duplex oligonucleotide

DRUGTelitacicept

fusion protein

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluate the safety and tolerability of ADX-038 as a monotherapy and in combination with telitacicept	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.

Countries

China

Contacts

CONTACTStephanie Leyva

info@adarx.com877-232-7974

STUDY_DIRECTORArezoo Mirad

ADARx Pharmaceuticals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026