IgA NephropathyPhase 2NCT06419205
A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
A Phase 2 study testing ADX-097 in people with IgA Nephropathy and Lupus Nephritis (LN), run by Akebia Therapeutics at 4 sites in 2 countries.
Trial summary
A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G) Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- IgA Nephropathy, Lupus Nephritis (LN), C3 (Complement Component 3) Glomerulopathy
- What is being tested?
- ADX-097
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 30 Jul 2026to Feb 2028
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All participants
- Male or female participants aged ≥16 years.
- uPCR ≥0.5 g/g (from the average of 3 first morning voids [FMVs]).
- Screening eGFR ≥30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR).
- Participants receiving a renin-angiotensin-aldosterone system (RAAS) inhibitor, sodium-glucose cotransporter-2 (SGLT2) inhibitor, sparsentan, or atrasenten must have been on a stable dose (at the maximum recommended dose according to local guidelines or maximum tolerated dose) for at least 8 weeks prior to Study Day 1 and the dose is projected to remain stable until completion of the study.
- Participants with IgAN only
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- Kidney biopsy-proven diagnosis of IgAN with a kidney biopsy that is obtained within 10 years of Day 1 or within 5 years of Day 1 if the participant is known or suspected of also having diabetic nephropathy.
- Participants with LN only
- Clinical diagnosis of systemic lupus erythematosus (SLE)
- Kidney biopsy-proven diagnosis of LN with a kidney biopsy that is obtained within 24 weeks of Day 1.
- Diagnosis of active focal or diffuse LN class III or IV
- Participants with C3G only
- Kidney biopsy-proven diagnosis of C3G, either dense deposit disease (DDD) or complement component 3 glomerulonephritis (C3GN), with a kidney biopsy that is obtained within 52 weeks of Day 1.
- Participants receiving mycophenolate mofetil (MMF) (or mycophenolic acid) or prednisone ≥10 mg/d or equivalent must have been on a stable dose for at least 12 weeks before Day 1 that is projected to remain stable until completion of the study.
Who cannot join
- Rapidly progressive glomerulonephritis defined as a 50% decline in eGFR within 12 weeks of screening.
- Concomitant significant renal disease other than IgAN, C3G, or LN per investigator discretion.
- Participants with a history of and/or presence of anti-factor H antibodies at screening.
- Uncontrolled hypertension with mean seated systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg based on the average of 2 measurements obtained at approximately 2-minute intervals after the individual has been sitting for 5 minutes.
- Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study.
- History of splenectomy.
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- Participants with IgAN only
- Secondary forms of IgAN
- Received systemic corticosteroid therapy, oral budenoside, or any other form of immunosuppressive therapy within 12 weeks before Day 1.
- Participants with LN only
- Lymphocyte count below 0.5 × 109/L at screening.
- Received any of Cyclophosphamide, Calcineurin inhibitors, IV methylprednisolone, IV immunoglobulin therapy, Belimumab, Obinutuzumab and Rituximab treatments at protocol specified time points.
- Participants with C3G only
- Evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G is secondary.
- Received systemic corticosteroid therapy, eculizumab, iptacopan, pegcetacoplan, or any other form of immunosuppressive therapy ≤12 weeks before Day 1, except for MMF (or mycophenolic acid), which is permitted.
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
United States3 sites, 3 recruiting
- Recruiting
Investigator Site #3
Hollywood, Florida, 33024
- Recruiting
Investigator Site #1
Lawrenceville, Georgia, 30046
- Recruiting
Investigator Site #4
Orangeburg, South Carolina, 29118
About this study
Official title: A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older With Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)
A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)
- Being tested
- ADX-097
- Keywords
- Immunoglobulin A Nephropathy, Lupus Nephritis, Complement Component 3 Glomerulopathy, ADX-097, C3G
- Medical subject headings
- Glomerulonephritis, IGA, Lupus Nephritis, Complement Component 3 Deficiency, Autosomal Recessive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX-097Drug
Subcutaneous Infusions
| Study group | Role | What they receive |
|---|---|---|
| Open Label: ADX-097 | Other | Participants will be administered ADX-097 weekly once Receives: Drug: ADX-097 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants reporting treatment emergent adverse events (TEAEs)
Measured: Up to 30 weeks
Secondary outcomes (3)
Change from baseline in urine protein-to-creatinine ratio (uPCR)
Measured: Baseline and up to 26 weeks
Change from baseline in estimated glomerular filtration rate (eGFR)
Measured: Baseline and up to 26 weeks
Trough plasma Concentration of ADX-097
Blood samples will be collected for the analysis of pharmacokinetic parameters at specified timepoints.
Measured: At Days 1, 8, 22, 50, 78, 106, 134 and 176
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start30 Jul 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akebia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419205
- Sponsor's protocol ID
- ADX-097-CI-0053
- Status last verified
- Sep 2026
- First submitted
- 8 May 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older With Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)
- ClinicalTrials.gov ID
- NCT06419205
- Acronym / sponsor ID
- ADX-097-CI-0053
- Keywords
- Immunoglobulin A Nephropathy, Lupus Nephritis, Complement Component 3 Glomerulopathy, ADX-097, C3G
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Akebia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 17 May 2024 (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.
A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label: ADX-097 | Other | Drug: ADX-097Participants will be administered ADX-097 weekly once |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- All participants
- Male or female participants aged ≥16 years.
- uPCR ≥0.5 g/g (from the average of 3 first morning voids [FMVs]).
- Screening eGFR ≥30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR).
- Participants receiving a renin-angiotensin-aldosterone system (RAAS) inhibitor, sodium-glucose cotransporter-2 (SGLT2) inhibitor, sparsentan, or atrasenten must have been on a stable dose (at the maximum recommended dose according to local guidelines or maximum tolerated dose) for at least 8 weeks prior to Study Day 1 and the dose is projected to remain stable until completion of the study.
Key exclusion criteria (15 listed)
- Rapidly progressive glomerulonephritis defined as a 50% decline in eGFR within 12 weeks of screening.
- Concomitant significant renal disease other than IgAN, C3G, or LN per investigator discretion.
- Participants with a history of and/or presence of anti-factor H antibodies at screening.
- Uncontrolled hypertension with mean seated systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg based on the average of 2 measurements obtained at approximately 2-minute intervals after the individual has been sitting for 5 minutes.
- Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study.
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-097Subcutaneous Infusions | Drug | Open Label: ADX-097 |
Primary outcome
Number of participants reporting treatment emergent adverse events (TEAEs)
Time frame: Up to 30 weeks
3 secondary outcomes
Change from baseline in urine protein-to-creatinine ratio (uPCR)
Time frame: Baseline and up to 26 weeks
Change from baseline in estimated glomerular filtration rate (eGFR)
Time frame: Baseline and up to 26 weeks
Trough plasma Concentration of ADX-097
Time frame: At Days 1, 8, 22, 50, 78, 106, 134 and 176
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 1 Oct 2026.
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ADX-097 in people with IgA Nephropathy and Lupus Nephritis (LN), run by Akebia Therapeutics at 4 sites in 2 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 14 inclusion and 15 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 1 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 4 sites in United States, Brazil. 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 Akebia Therapeutics (16178446128, trials@akebia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants reporting treatment emergent adverse events (TEAEs) (time frame: Up to 30 weeks). 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 1 Oct 2026.