IgA Nephropathy study: ADX-097
Official title A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G
ClinicalTrials.gov ID: NCT06419205
What this study is testing
What is ADX-097?
An investigational once‑daily subcutaneous injectable medicine being studied for IgA nephropathy, lupus nephritis, and complement component 3 glomerulopathy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe the drug is and how it behaves in the body. It will also see if the drug shows any signs of helping the kidney disease.
- Who it's for
- Adults 16 years or older who have IgA nephropathy, lupus nephritis, or C3 glomerulopathy.
- What's involved
- Participants will receive subcutaneous injections of ADX‑097 and will have regular blood and urine tests, as well as clinic visits to monitor safety and kidney function.
- Time commitment
- The study lasts about 12 months, with several clinic visits and blood draws scheduled throughout that period.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 16 and older
You may be able to join if
- Key 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...
You likely can't join if
- All participants
- 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...
- Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study.
See the full eligibility criteria
- Key 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...
- 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.
- 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...
- All participants
- 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...
- Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study.
- History of splenectomy. 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Hollywood, Florida, United States
- Lawrenceville, Georgia, United States
- Orangeburg, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 16 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hollywood, Florida, United States; Lawrenceville, Georgia, United States; Orangeburg, South Carolina, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.