Tests ADX-097 under the skin in people with IgA nephropathy, lupus nephritis or C3G
Tests ADX-097, given under the skin, in people 16 or older with kidney disease.
Plain-language title generated from the registry record
Registry title: A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
Key facts
- Where
- São Paulo, BrazilSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 16 or older with kidney disease from IgA nephropathy, lupus nephritis, or C3 glomerulopathy, confirmed by a kidney biopsy. They must have protein in the urine and kidney function above a set level.
- Age
- 16 years or older
- Sex
- All sexes
- Disease stage
- IgA nephropathy, lupus nephritis (active class III or IV, with lupus), or C3 glomerulopathy, proven by kidney biopsy. Urine protein (uPCR) of at least 0.5 g/g. Kidney function (eGFR) of at least 30 mL/min/1.73m2.
- Earlier treatment
- If taking a RAAS inhibitor, SGLT2 inhibitor, sparsentan or atrasenten, the dose must be stable for at least 8 weeks. In C3G, mycophenolate or prednisone of 10 mg/d or more must be stable for at least 12 weeks. In IgAN and C3G, no steroid or other immune-suppressing treatment within 12 weeks before Day 1 (mycophenolate is allowed in C3G).
- Biomarker or test result
- Urine protein (uPCR) of at least 0.5 g/g, from the average of 3 first-morning samples. Kidney function (eGFR) of at least 30 mL/min/1.73m2.
Main reasons for not taking part
- Kidney disease that is quickly getting worse (eGFR down 50% within 12 weeks)
- Another significant kidney disease besides IgAN, C3G or LN
- High blood pressure that is not controlled (160/100 mmHg or higher)
- Transplant of a kidney, other solid organ or bone marrow, before or during the study
- Removal of the spleen (splenectomy)
Read by machine on 12 November 2026.
Where in Brazil
- São PauloHospital not named in the registryContact: Akebia TherapeuticsNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Akebia Therapeutics
- Trial code
- NCT06419205
- Record updated
- 1 October 2026
- Original description
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 full original descriptionShow less
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)
Inclusion: 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; 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.
Exclusion: Concomitant significant renal disease other than IgAN, C3G, or LN per investigator discretion; Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study; Received systemic corticosteroid therapy, oral budenoside, or any other form of immunosuppressive therapy within 12 weeks before Day 1; Participants with LN only; 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; 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; 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; History of splenectomy; Participants with IgAN only; Evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G is secondary; Rapidly progressive glomerulonephritis defined as a 50% decline in eGFR within 12 weeks of screening; Lymphocyte count below 0.5 × 109/L at screening; Secondary forms of IgAN.