Experimental drug aims to protect kidneys in inflammatory diseases
NCT ID NCT06419205
First seen Jul 09, 2026 · Last updated Aug 05, 2026 · Updated 3 times
Summary
This study tests an experimental drug called ADX-097 in people aged 16 and older with three kidney conditions: IgA nephropathy, lupus nephritis, and C3 glomerulopathy. The drug is given as an injection under the skin and is designed to reduce inflammation and protein leakage in the urine. Researchers will monitor safety, how the drug moves through the body, and whether it helps preserve kidney function over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ADX-097
- What this could lead to
- If successful, ADX-097 could offer a new treatment option to slow kidney damage and reduce protein leakage in people with certain inflammatory kidney diseases.
- What could go wrong
- This is an early Phase 2 study with only 30 participants, so results may not apply to everyone. The drug may cause side effects or fail to improve kidney function.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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16 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: All participants 1. Male or female participants aged ≥16 years. 2. uPCR ≥0.5 g/g (from the average of 3 first morning voids \[FMVs\]). 3. Screening eGFR ≥30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR). 4. 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 5. 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 6. Clinical diagnosis of systemic lupus erythematosus (SLE) 7. Kidney biopsy-proven diagnosis of LN with a kidney biopsy that is obtained within 24 weeks of Day 1. 8. Diagnosis of active focal or diffuse LN class III or IV Participants with C3G only 9. 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. 10. 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. Key Exclusion Criteria All participants 1. Rapidly progressive glomerulonephritis defined as a 50% decline in eGFR within 12 weeks of screening. 2. Concomitant significant renal disease other than IgAN, C3G, or LN per investigator discretion. 3. Participants with a history of and/or presence of anti-factor H antibodies at screening. 4. 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. 5. Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study. 6. History of splenectomy. Participants with IgAN only 7. Secondary forms of IgAN 8. Received systemic corticosteroid therapy, oral budenoside, or any other form of immunosuppressive therapy within 12 weeks before Day 1. Participants with LN only 9. Lymphocyte count below 0.5 × 109/L at screening. 10. 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 11. Evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G is secondary. 12. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
2 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Investigator Site #1
RECRUITINGLawrenceville, Georgia, 30046, United States
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Investigator Site #2
NOT_YET_RECRUITINGSão Paulo, Brazil
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- Can remote care and pharmacists improve lupus kidney treatment?
- Blood marker may foretell kidney disease severity
- Can a massive kidney database unlock IgA Nephropathy's secrets?