ClinicalTrials.gg
RecruitingNCT06989359Updated Oct 20, 2026

Phase 2 Study of ADX-038 in Complement-Mediated Kidney Disease

A Phase 2 interventional study of ADX-038 Dose Level 2 and ADX-038 Dose Level 1 in IgAN, C3G and Complement-mediated Kidney Disease, sponsored by ADARx Pharmaceuticals, Inc.. Recruiting at 38 sites in 8 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by ADARx Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2025; still recruiting 1 year 2 months later.
Updated Oct 20, 2026Site recruiting status changedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
45
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This Phase 2 study is designed to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in adults with complement-mediated kidney diseases.

02

Conditions studied

  • IgAN
  • C3G
  • Complement-mediated Kidney Disease
  • IgA Nephropathy (IgAN)
  • IC-MPGN

Keywords

  • IgA Nephropathy
  • IgAN
  • C3G
  • IC-MPGN
  • complement-mediated kidney disease
03

In context

Glomerulonephritis, IGA

275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.

This study's planned enrollment of 45 is below the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.

Browse Glomerulonephritis, IGA studies →

Lead sponsor

ADARx Pharmaceuticals, Inc. is the lead sponsor of 9 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Mean greater than or equal to 30 mL/min/1.73m2
  • Clinical evidence of active kidney disease
  • Treated with supportive care including an ACE inhibitor or ARB if applicable
  • Willing to receive required vaccinations
  • Primary diagnosis of IgAN, C3G or IC-MPGN confirmed by a kidney

Exclusion criteria

Exclusion Criteria:

  • Hereditary or acquired complement deficiency
  • Kidney transplant or renal replacement therapy
  • History of solid organ transplant
  • Other kidney disease
  • History of recurrent invasive infections
  • Received complement inhibitor treatments
  • Active systemic viral, bacterial, or fungal infection
  • Abnormal liver function
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    ADX-038 Dose Level 1 - IgAN

    Drug: ADX-038 Dose Level 1

  • Experimental
    ADX-038 Dose Level 1 - C3G

    Drug: ADX-038 Dose Level 1

  • Experimental
    ADX-038 Dose Level 2 - IgAN

    Drug: ADX-038 Dose Level 2

Interventions

06

What researchers measure

Primary outcomes

  1. Evaluate the safety and tolerability of ADX-038

    Incidence and severity of TEAEs

    Time frame: Length of study - 36 months

07

Study locations

33 of 38 sites recruiting
  • ADARx Clinical Site
    Doral, Florida 33122, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • ADARx Clinical Site
    Miami, Florida 33127, United States
    Recruiting
  • ADARx Clinical Site
    Pembroke Pines, Florida 33029, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • ADARx Clinical Site
    Iowa City, Iowa 52242, United States
    Recruiting
  • ADARx Clinical Site
    Shreveport, Louisiana 71101, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • ADARx Clinical Site
    Shelby, Michigan 48315, United States
    Recruiting
  • ADARx Clinical Site
    Great Neck, New York 11021, United States
    Recruiting
  • ADARx Clinical Site
    Columbus, Ohio 43210, United States
    Recruiting
  • ADARx Clinical Site
    Dakota Dunes, South Dakota 57049, United States
    Recruiting
  • ADARx Clinical Site
    Dallas, Texas 75230, United States
    Withdrawn

    Not enrolling at this site — choose another above.

  • ADARx Clinical Site
    Houston, Texas 77027, United States
    Recruiting
  • ADARx Clinical Site
    Liverpool, New South Wales 2170, Australia
    Recruiting
  • ADARx Clinical Site
    Wollongong, New South Wales 2500, Australia
    Recruiting
  • ADARx Clinical Site
    Sydney, NSW 2139, Australia
    Recruiting
  • ADARx Clinical Site
    Woolloongabba, QLD 4102, Australia
    Recruiting
  • ADARx Clinical Site
    Hong Kong, 2500, Hong Kong
    Recruiting
  • ADARx Clinical Site
    Shatin, Hong Kong
    Recruiting
  • ADARx Clinical Site
    Bergamo, 24020, Italy
    Recruiting
  • ADARx Clinical Site
    Bologna, 40138, Italy
    Recruiting
  • ADARx Clinical Site
    Pavia, 27100, Italy
    Recruiting
  • ADARx Clinical Site
    Wŏnju, Gangwon-do 26426, South Korea
    Recruiting
  • ADARx Clinical Site
    Gyeonggi-do, Gurogu 16499, South Korea
    Recruiting
  • ADARx Clinical Site
    Seoul, Gurogu 08308, South Korea
    Recruiting
  • ADARx Clinical Site
    Cheonan, 31151, South Korea
    Recruiting
  • ADARx Clinical Site
    Daegu, 42601, South Korea
    Recruiting
  • ADARx Clinical Site
    Gyeonggi-do, 05278, South Korea
    Recruiting
  • ADARx Clinical Site
    Seoul, 02841, South Korea
    Recruiting
  • ADARx Clinical Site
    Seoul, 03080, South Korea
    Recruiting
  • ADARx Clinical Site
    Seoul, 03722, South Korea
    Recruiting
  • ADARx Clinical Site
    Seoul, 05278, South Korea
    Recruiting
  • ADARx Clinical Site
    Barcelona, 08035, Spain
    Recruiting
  • ADARx Clinical Site
    Madrid, 28040, Spain
    Recruiting
  • ADARx Clinical Site
    Madrid, 28041, Spain
    Recruiting
  • ADARx Clinical Site
    Seville, 41009, Spain
    Recruiting
  • ADARx Clinical Site
    Kaohsiung City, 833401, Taiwan
    Not yet recruiting
  • ADARx Clinical Site
    New Taipei City, 110, Taiwan
    Recruiting
  • ADARx Clinical Site
    Leicester, BC LE5 4PW, United Kingdom
    Recruiting
  • ADARx Clinical Site
    Newcastle upon Tyne, UK, NE7 7DN, United Kingdom
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
2 sites changed recruiting status (1 now withdrawn, 1 now recruiting)
Show 2 sites
  • ADARx Clinical Site · Shreveport, United StatesRecruiting→Withdrawn
  • ADARx Clinical Site · Bologna, ItalyNot yet recruiting→Recruiting
Oct 20, 2026
Show all 1 update
  1. Oct 20, 2026
    2 sites changed recruiting status (1 now withdrawn, 1 now recruiting)
    Show 2 sites
    • ADARx Clinical Site · Shreveport, United StatesRecruiting→Withdrawn
    • ADARx Clinical Site · Bologna, ItalyNot yet recruiting→Recruiting
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06989359
Lead sponsor
ADARx Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
May 25, 2025
Start date
Aug 28, 2025
Primary completion
Dec 31, 2028 (estimated)
Completion
Jun 2029 (estimated)
Last update
Oct 20, 2026

Study contacts

Tracy Nguyen
Contact
info@adarx.com
877-232-7974
Arezoo Mirad, MD
study director · ADARx Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: ADX-038

Start the discussion