ADX-097 for IgA Nephropathy, Lupus Nephritis, or C3G

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

Recruiting Phase 2 Interventional Study
IgA Nephropathy Lupus Nephritis (LN) C3 (Complement Component 3) Glomerulopathy
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
16 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
Akebia Therapeutics · Industry
Who this trial is looking for

This trial is looking for men and women aged 16 and older with IgA Nephropathy, Lupus Nephritis, or C3 Glomerulopathy. Participants will receive the treatment ADX-097 and will need to meet specific health criteria to join.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 16 years old.
  • I have been diagnosed with IgA Nephropathy, Lupus Nephritis, or C3G.
  • I have a specific level of protein in my urine.
  • I have a kidney function measure above a certain level.
  • I have had my kidney condition confirmed by a biopsy.
  • I am stable on certain medications if I am taking them.

You may not be able to join if

  • I have rapidly progressing kidney disease.
  • I have other significant kidney diseases.
  • I have uncontrolled high blood pressure.
  • I have received certain therapies or medications recently.
  • I have had a spleen removal.
  • I have received a kidney or other organ transplant.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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)

Trial Locations
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Eligibility Criteria
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). …
Contacts

Akebia Therapeutics

16178446128

trials@akebia.com

CONTACT