Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease

Part of paid clinical trials in Doral, Florida.

Sponsor
ADARx Pharmaceuticals, Inc.
Study ID
NCT06989359
Phase
PHASE2
Status
Recruiting

Conditions

  • C3G
  • Complement-mediated Kidney Disease
  • IC-MPGN
  • IgA Nephropathy (IgAN)
  • IgAN

Eligibility Criteria

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

Interventions

  • ADX-038 Dose Level 2 — DRUG
    siRNA duplex oligonucleotide
  • ADX-038 Dose Level 1 — DRUG
    siRNA duplex oligonucleotide

Study Details

This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.

Key Dates

Start date
Aug 28, 2025
Status verified
Jun 2026
Primary completion
Dec 31, 2028
Completion
Jun 30, 2029

Study Design

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

Arms

  • Experimental: ADX-038 Dose Level 1 - IgAN
  • Experimental: ADX-038 Dose Level 1 - C3G
  • Experimental: ADX-038 Dose Level 2 - IgAN

Primary Outcome Measure

Evaluate the safety and tolerability of ADX-038 [ Time Frame: Length of study - 36 months ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
ADARx Clinical SiteDoralFlorida33122-
ADARx Clinical SiteMiamiFlorida33127-
ADARx Clinical SitePembroke PinesFlorida33029-
ADARx Clinical SiteIowa CityIowa52242-
ADARx Clinical SiteShreveportLouisiana71101-
ADARx Clinical SiteShelbyMichigan48315-
ADARx Clinical SiteGreat NeckNew York11021-
ADARx Clinical SiteColumbusOhio43210-
ADARx Clinical SiteDakota DunesSouth Dakota57049-
ADARx Clinical SiteDallasTexas75230-
ADARx Clinical SiteHoustonTexas77027-

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