Recruiting NCT06989359
Phase 2 Study of ADX-038 in Complement-Mediated 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 Dose Level 2, ADX-038 Dose Level 1.
- Who it may be relevant to
- Registry conditions: IgAN, C3G, Complement-mediated Kidney Disease, IgA Nephropathy (IgAN). 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
- United States, Australia, Hong Kong, Italy, South Korea +3
- 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 Participants With Complement-Mediated Kidney Disease
Overview
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.
Interventions
- Drug ADX-038 Dose Level 2
siRNA duplex oligonucleotide - Drug ADX-038 Dose Level 1
siRNA duplex oligonucleotide
Primary outcome measures
- Evaluate the safety and tolerability of ADX-038 [Time frame: Length of study - 36 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
- Hereditary or acquired complement deficiency
- Kidney transplant or renal replacement therapy
- History of solid organ transplant
- Other kidney disease
- History of recurrent invasive infections
- Received complement inhibitor treatments
- Active systemic viral, bacterial, or fungal 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
United States · 11 centers
- ADARx Clinical Site — Doral
- ADARx Clinical Site — Miami
- ADARx Clinical Site — Pembroke Pines
- ADARx Clinical Site — Iowa City
- ADARx Clinical Site — Shreveport
- ADARx Clinical Site — Shelby
- ADARx Clinical Site — Great Neck
- ADARx Clinical Site — Columbus
- … and 3 more centers
South Korea · 10 centers
- ADARx Clinical Site — Wŏnju
- ADARx Clinical Site — Gyeonggi-do
- ADARx Clinical Site — Seoul
- ADARx Clinical Site — Cheonan
- ADARx Clinical Site — Daegu
- ADARx Clinical Site — Gyeonggi-do
- ADARx Clinical Site — Seoul
- ADARx Clinical Site — Seoul
- … and 2 more centers
Australia · 4 centers
- ADARx Clinical Site — Liverpool
- ADARx Clinical Site — Wollongong
- ADARx Clinical Site — Sydney
- ADARx Clinical Site — Woolloongabba
Spain · 3 centers
- ADARx Clinical Site — Barcelona
- ADARx Clinical Site — Madrid
- ADARx Clinical Site — Seville
Hong Kong · 2 centers
- ADARx Clinical Site — Hong Kong
- ADARx Clinical Site — Shatin
Italy · 2 centers
- ADARx Clinical Site — Bergamo
- ADARx Clinical Site — Pavia
Taiwan · 1 center
- ADARx Clinical Site — New Taipei City
United Kingdom · 1 center
- ADARx Clinical Site — Newcastle upon Tyne
Identifiers
NCT: NCT06989359 · ADX-038-201