Chinese Adults With Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ADX-038, Telitacicept.
- Who it may be relevant to
- Registry conditions: Immunoglobulin A Nephropathy (IgAN), Complement 3 Glomerulopathy (C3G), IC-MPGN. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 2 Study to Assess ADX-038 in Chinese Adults With Complement-Mediated Kidney Disease
Overview
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
- Drug ADX-038
siRNA duplex oligonucleotide - Drug Telitacicept
fusion protein
Primary outcome measures
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 9 centers
- ADARx Clinical Site — Shenzhen
- ADARx Clinical Site — Guiyang
- ADARx Clinical Site — Zhengzhou
- ADARx Clinical Site — Baotou
- ADARx Clinical Site — Wuxi
- ADARx Clinical Site — Yantai
- ADARx Clinical Site — Beijing
- ADARx Clinical Site — Shandong
- … and 1 more center
Identifiers
NCT: NCT07522099 · ADX-038-204