A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G

July 8, 2026 updated by: Akebia Therapeutics

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 00000
        • Denver
    • Minnesota
      • Minneapolis, Minnesota, United States, 00000
        • Minneapolis
    • Nevada
      • Las Vegas, Nevada, United States, 00000
        • Las Vegas
    • New York
      • New York City, New York, United States, 00000
        • New York
    • Ohio
      • Columbus, Ohio, United States, 00000
        • Columbus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Open Label: ADX-097
Participants will be administered ADX-097 weekly once
Drug: ADX-097
Subcutaneous Infusions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants reporting treatment emergent adverse events (TEAEs)
Time Frame: Up to 30 weeks
Up to 30 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in urine protein-to-creatinine ratio (uPCR)
Time Frame: Baseline and up to 26 weeks
Baseline and up to 26 weeks
Change from baseline in estimated glomerular filtration rate (eGFR)
Time Frame: Baseline and up to 26 weeks
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
Blood samples will be collected for the analysis of pharmacokinetic parameters at specified timepoints.
At Days 1, 8, 22, 50, 78, 106, 134 and 176

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akebia Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

May 8, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 17, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 8, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADX-097-CI-0053

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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