Immunoglobulin A Nephropathy (IgAN)Phase 2NCT07522099
Chinese Adults With Kidney Disease
A Phase 2 study testing ADX-038 and Telitacicept in people with Immunoglobulin A Nephropathy (IgAN) and Complement 3 Glomerulopathy (C3G), run by ADARx Pharmaceuticals, Inc. at 9 sites in China.
Trial summary
This is a Phase 2 study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics of ADX-038 in adults with complement-mediated kidney diseases. The study will enroll Chinese adults with IgA nephropathy, complement 3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunoglobulin A Nephropathy (IgAN), Complement 3 Glomerulopathy (C3G), IC-MPGN
- What is being tested?
- ADX-038 and Telitacicept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 9 sitesChina
- Study dates
- 21 May 2026to 21 Jan 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
- Previous kidney transplant or major solid organ transplant
- Required renal replacement therapy for more than 72 hours
- Rapidly progressive glomerular nephritis or acute kidney injury
- History of recurrent invasive infection
- Current or previous use of C5 or CFB inhibitors (such as eculizumab, ravulizumab or iptacopan)
- Active TB, HIV or other systemic infection
- Abnormal liver function
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
ADARx Clinical Site
Baotou, Inner Mongolia, 014000
- Recruiting
ADARx Clinical Site
Beijing, 100034
- Recruiting
ADARx Clinical Site
Guiyang, Guizhou
- Recruiting
ADARx Clinical Site
Shandong
- Recruiting
ADARx Clinical Site
Shanghai
- Recruiting
ADARx Clinical Site
Shenzhen, Guangdong, 518100
- Recruiting
ADARx Clinical Site
Wuxi, Jiangsu, 214000
- Recruiting
ADARx Clinical Site
Yantai, Shandong, 264008
- Recruiting
ADARx Clinical Site
Zhengzhou, Henan
About this study
Official title: A Phase 2 Study to Assess ADX-038 in Chinese Adults With Complement-Mediated Kidney Disease
This is a Phase 2 study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics of ADX-038 in adults with complement-mediated kidney diseases. The study will enroll Chinese adults with IgA nephropathy, complement 3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study will evaluate ADX-038 administered alone (Part A) and in combination with telitacicept (Part B).
- Being tested
- ADX-038, Telitacicept
- Keywords
- IgAN, C3G, IC-MPGN, complement mediated kidney diseases, IgA Nephropathy
- Medical subject headings
- Glomerulonephritis, IGA, Glomerulonephritis, Membranoproliferative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX-038Drug
siRNA duplex oligonucleotide
TelitaciceptDrug
fusion protein
| Study group | Role | What they receive |
|---|---|---|
| Part A - ADX-038 Monotherapy | Experimental | Not described Receives: Drug: ADX-038 |
| Part B - ADX-038 Combination Therapy | Experimental | Not described Receives: Drug: ADX-038; Drug: Telitacicept |
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 as a monotherapy and in combination with telitacicept
Evaluate the proportion of patients with treatment emergent adverse events (TEAEs) with ADX-038 and telitacicept versus those on ADX-038 alone.
Measured: Part A - 24 Months and Part B - 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start21 May 2026
- Primary completion10 Jul 2028 (estimated)
- Study completion21 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immunoglobulin A Nephropathy (IgAN)Studies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ADARx Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arezoo Mirad, Study director, ADARx Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522099
- Sponsor's protocol ID
- ADX-038-204
- Status last verified
- Sep 2026
- First submitted
- 27 Feb 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 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 Chinese Adults With Complement-Mediated Kidney Disease
- ClinicalTrials.gov ID
- NCT07522099
- Acronym / sponsor ID
- ADX-038-204
- Keywords
- IgAN, C3G, IC-MPGN, complement mediated kidney diseases, IgA Nephropathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ADARx Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 May 2026 (actual)
- Primary completion
- 10 Jul 2028 (estimated)
- Study completion
- 21 Jan 2029 (estimated)
- First posted
- 13 Apr 2026 (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 is a Phase 2 study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics of ADX-038 in adults with complement-mediated kidney diseases. The study will enroll Chinese adults with IgA nephropathy, complement 3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study will evaluate ADX-038 administered alone (Part A) and in combination with telitacicept (Part B).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A - ADX-038 Monotherapy | Experimental | Drug: ADX-038 |
| Part B - ADX-038 Combination Therapy | Experimental | Drug: ADX-038, Drug: Telitacicept |
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 (7 listed)
- Previous kidney transplant or major solid organ transplant
- Required renal replacement therapy for more than 72 hours
- Rapidly progressive glomerular nephritis or acute kidney injury
- History of recurrent invasive infection
- Current or previous use of C5 or CFB inhibitors (such as eculizumab, ravulizumab or iptacopan)
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-038siRNA duplex oligonucleotide | Drug | Part A - ADX-038 Monotherapy, Part B - ADX-038 Combination Therapy |
| Telitaciceptfusion protein | Drug | Part B - ADX-038 Combination Therapy |
Primary outcome
Evaluate the safety and tolerability of ADX-038 as a monotherapy and in combination with telitacicept
Time frame: Part A - 24 Months and Part B - 15 months
Evaluate the proportion of patients with treatment emergent adverse events (TEAEs) with ADX-038 and telitacicept versus those on ADX-038 alone.
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 3 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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 study director
ADARx Pharmaceuticals
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADX-038 and Telitacicept in people with Immunoglobulin A Nephropathy (IgAN) and Complement 3 Glomerulopathy (C3G), run by ADARx Pharmaceuticals, Inc. at 9 sites in China.
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 7 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 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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 Stephanie Leyva (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 as a monotherapy and in combination with telitacicept (time frame: Part A - 24 Months and Part B - 15 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 3 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.