Chinese Adults With Kidney Disease

Sponsor
ADARx Pharmaceuticals, Inc.
Study ID
NCT07522099
Phase
PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ADX-038 — DRUG
    siRNA duplex oligonucleotide
  • Telitacicept — DRUG
    fusion protein

Study Details

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).

Key Dates

Start date
May 21, 2026
Status verified
Jun 2026
Primary completion
Jul 10, 2028
Completion
Jan 21, 2029

Study Design

Enrollment
30 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A - ADX-038 Monotherapy
  • Experimental: Part B - ADX-038 Combination Therapy

Primary Outcome Measure

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 ]

Central Contacts

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