Actively Recruiting
A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease
Led by ADARx Pharmaceuticals, Inc. · Updated on 2026-06-08
45
Participants Needed
29
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating ADX-038, an investigational siRNA drug, in adults with complement-mediated kidney diseases such as IgA Nephropathy (IgAN), C3 Glomerulopathy (C3G), and Immune Complex-Mediated Membranoproliferative Glomerulonephritis (IC-MPGN). This Phase 2 study aims to assess the safety, effectiveness, and how the drug behaves in the body for these kidney conditions. The study is sponsored by ADARx Pharmaceuticals, Inc. The study involves administration of ADX-038 at two different dose levels as an experimental treatment. Participants receive one of these doses to evaluate their impact on kidney disease. The treatment is given alongside supportive care, including ACE inhibitors or ARBs when applicable. Participants must be willing to receive required vaccinations during the study. Participants will be monitored over 36 months to evaluate the safety and tolerability of ADX-038. The study includes regular assessments of kidney function and disease activity, with ongoing observation to track any side effects or changes in health. Researchers will measure how well the drug is tolerated and its effects on complement-mediated kidney disease during this period.
CONDITIONS
Brief Title
Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Mean eGFR greater than or equal to 30 mL/min/1.73m2
- Clinical evidence of active kidney disease
- Receiving 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 kidney biopsy
You will not qualify if you...
- Hereditary or acquired complement deficiency
- History of kidney transplant or renal replacement therapy
- History of solid organ transplant
- Presence of other kidney diseases
- History of recurrent invasive infections
- Prior treatment with complement inhibitor therapies
- Active systemic viral, bacterial, or fungal infection
- Abnormal liver function
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 36 months
Participants receive ADX-038, a drug administered as siRNA duplex oligonucleotide, to treat complement-mediated kidney disease. The treatment aims to evaluate safety and tolerability over time.
Regular visits throughout treatment period
Trial Site Locations
Total: 29 locations
1
ADARx Clinical Site
Doral, Florida, United States, 33122
Actively Recruiting
2
ADARx Clinical Site
Miami, Florida, United States, 33127
Actively Recruiting
3
ADARx Clinical Site
Pembroke Pines, Florida, United States, 33029
Actively Recruiting
4
ADARx Clinical Site
Iowa City, Iowa, United States, 52242
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5
ADARx Clinical Site
Shreveport, Louisiana, United States, 71101
Actively Recruiting
6
ADARx Clinical Site
Shelby, Michigan, United States, 48315
Actively Recruiting
7
ADARx Clinical Site
Great Neck, New York, United States, 11021
Actively Recruiting
8
ADARx Clinical Site
Columbus, Ohio, United States, 43210
Actively Recruiting
9
ADARx Clinical Site
Dakota Dunes, South Dakota, United States, 57049
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10
ADARx Clinical Site
Dallas, Texas, United States, 75230
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11
ADARx Clinical Site
Houston, Texas, United States, 77027
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12
ADARx Clinical Site
Liverpool, New South Wales, Australia, 2170
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13
ADARx Clinical Site
Wollongong, New South Wales, Australia, 2500
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14
ADARx Clinical Site
Sydney, Australia, NSW 2139
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15
ADARx Clinical Site
Woolloongabba, Australia, QLD 4102
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16
ADARx Clinical Site
Hong Kong, Hong Kong, 2500
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17
ADARx Clinical Site
Shatin, Hong Kong
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18
ADARx Clinical Site
Wŏnju, Gangwon-do, South Korea, 26426
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19
ADARx Clinical Site
Cheonan, South Korea, 31151
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20
ADARx Clinical Site
Daegu, South Korea, 42601
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21
ADARx Clinical Site
Gyeonggi-do, South Korea, 05278
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22
ADARx Clinical Site
Seoul, South Korea, 02841
Actively Recruiting
23
ADARx Clinical Site
Seoul, South Korea, 03080
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24
ADARx Clinical Site
Seoul, South Korea, 03722
Actively Recruiting
25
ADARx Clinical Site
Seoul, South Korea, 05278
Actively Recruiting
26
ADARx Clinical Site
Barcelona, Spain, 08035
Actively Recruiting
27
ADARx Clinical Site
Madrid, Spain, 28041
Actively Recruiting
28
ADARx Clinical Site
Seville, Spain, 41009
Actively Recruiting
29
ADARx Clinical Site
Newcastle upon Tyne, United Kingdom, UK, NE7 7DN
Actively Recruiting
Research Team
T
Tracy Nguyen
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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