Immunoglobulin A Nephropathy (IgAN)Complement 3 Glomerulopathy (C3G)IC-MPGN
Investigational drug(s) / intervention(s)
ADX-038Telitacicept
ADX-038: siRNA duplex oligonucleotide
Telitacicept: fusion protein
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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