Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease
NCT ID: NCT06989359
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
45 participants
INTERVENTIONAL
2025-08-28
2028-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ADX-038 Dose Level 1 - IgAN
ADX-038 Dose Level 1
siRNA duplex oligonucleotide
ADX-038 Dose Level 1 - C3G
ADX-038 Dose Level 1
siRNA duplex oligonucleotide
ADX-038 Dose Level 2 - IgAN
ADX-038 Dose Level 2
siRNA duplex oligonucleotide
Interventions
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ADX-038 Dose Level 2
siRNA duplex oligonucleotide
ADX-038 Dose Level 1
siRNA duplex oligonucleotide
Eligibility Criteria
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Inclusion Criteria
* Clinical evidence of active kidney disease
* Been on supportive care
* vaccine requirements
* Females must not be pregnant or breastfeeding
* Men must agree to use acceptable contraception and not donate sperm
* IgAN: confirmed disease by kidney biopsy performed within 60 months prior to screening
* C3G/IC-MPGN: confirmed disease by kidney biopsy performed within 18 months prior to screening
Exclusion Criteria
* 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
* Liver dysfunction
* No donating blood
18 Years
ALL
No
Sponsors
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ADARx Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Aditya Patel, MD
Role: STUDY_DIRECTOR
ADARx Pharmaceuticals, Inc.
Locations
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ADARx Clinical Site
Shreveport, Louisiana, United States
ADARx Clinical Site
Shelby, Michigan, United States
ADARx Clinical Site
Dakota Dunes, South Dakota, United States
ADARx Clinical Site
Dallas, Texas, United States
ADARx Clinical Site
Houston, Texas, United States
ADARx Clinical Site
Wollongong, New South Wales, Australia
ADARx Clinical Site
Pok Fu Lam, , Hong Kong
ADARx Clinical Site
Shatin, , Hong Kong
ADARx Clinical Site
Gyeonggi-do, New South Wales, South Korea
ADARx Clinical Site
Seoul, New South Wales, South Korea
ADARx Clinical Site
Cheonan, , South Korea
ADARx Clinical Site
Seoul, , South Korea
Countries
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Central Contacts
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Other Identifiers
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ADX-038-201
Identifier Type: -
Identifier Source: org_study_id
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