Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID06989359

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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

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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

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9

ADARx Clinical Site

Dakota Dunes, South Dakota, United States, 57049

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10

ADARx Clinical Site

Dallas, Texas, United States, 75230

Actively Recruiting

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

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23

ADARx Clinical Site

Seoul, South Korea, 03080

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24

ADARx Clinical Site

Seoul, South Korea, 03722

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25

ADARx Clinical Site

Seoul, South Korea, 05278

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26

ADARx Clinical Site

Barcelona, Spain, 08035

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27

ADARx Clinical Site

Madrid, Spain, 28041

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28

ADARx Clinical Site

Seville, Spain, 41009

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29

ADARx Clinical Site

Newcastle upon Tyne, United Kingdom, UK, NE7 7DN

Actively Recruiting

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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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