IgANPhase 2NCT06989359
Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease
A Phase 2 study testing ADX-038 Dose Level 2 and ADX-038 Dose Level 1 in people with IgAN and C3G, run by ADARx Pharmaceuticals, Inc. at 38 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgAN, C3G, Complement-mediated Kidney Disease
- What is being tested?
- ADX-038 Dose Level 2 and ADX-038 Dose Level 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 38 sitesin 8 countries
- Study dates
- 28 Aug 2025to Jun 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
38 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
38 sites in 8 countries
United States11 sites, 7 recruiting
- Recruiting
ADARx Clinical Site
Columbus, Ohio, 43210
- Recruiting
ADARx Clinical Site
Dakota Dunes, South Dakota, 57049
- Withdrawn
ADARx Clinical Site
Dallas, Texas, 75230
- Withdrawn
ADARx Clinical Site
Doral, Florida, 33122
- Recruiting
ADARx Clinical Site
Great Neck, New York, 11021
- Recruiting
ADARx Clinical Site
Houston, Texas, 77027
- Recruiting
ADARx Clinical Site
Iowa City, Iowa, 52242
- Recruiting
ADARx Clinical Site
Miami, Florida, 33127
- Withdrawn
ADARx Clinical Site
Pembroke Pines, Florida, 33029
- Recruiting
ADARx Clinical Site
Shelby, Michigan, 48315
- Withdrawn
ADARx Clinical Site
Shreveport, Louisiana, 71101
South Korea10 sites, 10 recruiting
- Recruiting
ADARx Clinical Site
Cheonan, 31151
- Recruiting
ADARx Clinical Site
Daegu, 42601
- Recruiting
ADARx Clinical Site
Gyeonggi-do, Gurogu, 16499
- Recruiting
ADARx Clinical Site
Gyeonggi-do, 05278
- Recruiting
ADARx Clinical Site
Seoul, Gurogu, 08308
- Recruiting
ADARx Clinical Site
Seoul, 02841
- Recruiting
ADARx Clinical Site
Seoul, 03080
- Recruiting
ADARx Clinical Site
Seoul, 03722
- Recruiting
ADARx Clinical Site
Seoul, 05278
- Recruiting
ADARx Clinical Site
Wŏnju, Gangwon-do, 26426
Australia4 sites, 4 recruiting
- Recruiting
ADARx Clinical Site
Liverpool, New South Wales, 2170
- Recruiting
ADARx Clinical Site
Sydney, NSW 2139
- Recruiting
ADARx Clinical Site
Wollongong, New South Wales, 2500
- Recruiting
ADARx Clinical Site
Woolloongabba, QLD 4102
Spain4 sites, 4 recruiting
- Recruiting
ADARx Clinical Site
Barcelona, 08035
- Recruiting
ADARx Clinical Site
Madrid, 28040
- Recruiting
ADARx Clinical Site
Madrid, 28041
- Recruiting
ADARx Clinical Site
Seville, 41009
Italy3 sites, 3 recruiting
- Recruiting
ADARx Clinical Site
Bergamo, 24020
- Recruiting
ADARx Clinical Site
Bologna, 40138
- Recruiting
ADARx Clinical Site
Pavia, 27100
Hong Kong2 sites, 2 recruiting
- Recruiting
ADARx Clinical Site
Hong Kong, 2500
- Recruiting
ADARx Clinical Site
Shatin
Taiwan2 sites, 2 recruiting
- Not yet recruiting
ADARx Clinical Site
Kaohsiung City, 833401
- Recruiting
ADARx Clinical Site
New Taipei City, 110
United Kingdom2 sites, 2 recruiting
- Recruiting
ADARx Clinical Site
Leicester, BC, LE5 4PW
- Recruiting
ADARx Clinical Site
Newcastle upon Tyne, UK, NE7 7DN
About this study
Official title: A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease
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.
- Conditions
- IgAN, C3G, Complement-mediated Kidney Disease, IgA Nephropathy (IgAN), IC-MPGN
- Being tested
- ADX-038 Dose Level 2, ADX-038 Dose Level 1
- Keywords
- IgA Nephropathy, IgAN, C3G, IC-MPGN, complement-mediated kidney disease
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX-038 Dose Level 2Drug
siRNA duplex oligonucleotide
ADX-038 Dose Level 1Drug
siRNA duplex oligonucleotide
| Study group | Role | What they receive |
|---|---|---|
| ADX-038 Dose Level 1 - IgAN | Experimental | Not described Receives: Drug: ADX-038 Dose Level 1 |
| ADX-038 Dose Level 1 - C3G | Experimental | Not described Receives: Drug: ADX-038 Dose Level 1 |
| ADX-038 Dose Level 2 - IgAN | Experimental | Not described Receives: Drug: ADX-038 Dose Level 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of ADX-038
Incidence and severity of TEAEs
Measured: Length of study - 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start28 Aug 2025
- Primary completion31 Dec 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgANStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ADARx Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arezoo Mirad, MD, Study director, ADARx Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989359
- Sponsor's protocol ID
- ADX-038-201
- Status last verified
- Oct 2026
- First submitted
- 22 May 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease
- ClinicalTrials.gov ID
- NCT06989359
- Acronym / sponsor ID
- ADX-038-201
- Conditions
- IgAN, C3G, Complement-mediated Kidney Disease, IgA Nephropathy (IgAN), IC-MPGN
- Keywords
- IgA Nephropathy, IgAN, C3G, IC-MPGN, complement-mediated kidney disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- ADARx Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ADX-038 Dose Level 1 - IgAN | Experimental | Drug: ADX-038 Dose Level 1 |
| ADX-038 Dose Level 1 - C3G | Experimental | Drug: ADX-038 Dose Level 1 |
| ADX-038 Dose Level 2 - IgAN | Experimental | Drug: ADX-038 Dose Level 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Hereditary or acquired complement deficiency
- Kidney transplant or renal replacement therapy
- History of solid organ transplant
- Other kidney disease
- History of recurrent invasive infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADX-038 Dose Level 2siRNA duplex oligonucleotide | Drug | ADX-038 Dose Level 2 - IgAN |
| ADX-038 Dose Level 1siRNA duplex oligonucleotide | Drug | ADX-038 Dose Level 1 - C3G, ADX-038 Dose Level 1 - IgAN |
Primary outcome
Evaluate the safety and tolerability of ADX-038
Time frame: Length of study - 36 months
Incidence and severity of TEAEs
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for IgAN
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A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
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Efficacy and Safety of Obinutuzumab Beta in Primary IgA Nephropathy With Active Pathological Lesions
Primary IgA Nephropathy
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A Phase 3b Study of Participant Experience on Povetacicept Administered Via Autoinjector as Compared to Sibeprenlimab Administered Via Prefilled Syringe
Immunoglobulin A Nephropathy
Not yet recruitingPhase 2
A Study to Learn About the Effects of Felzartamab on the Kidneys of Adults With Immunoglobulin A Nephropathy (IgAN)
Immunoglobulin A Nephropathy
Not yet recruitingPhase 1
IBI3034 Study in Healthy Adults and Patients With Primary IgA Nephropathy
IgA Nephropathy (IgAN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arezoo Mirad, MD study director
ADARx Pharmaceuticals, Inc.
38 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADX-038 Dose Level 2 and ADX-038 Dose Level 1 in people with IgAN and C3G, run by ADARx Pharmaceuticals, Inc. at 38 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, South Korea, Australia, Spain, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tracy Nguyen (877-232-7974, info@adarx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of ADX-038 (time frame: Length of study - 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.