ClinicalTrials.gg
RecruitingNCT07522099Updated Sep 3, 2026

Chinese Adults With Kidney Disease

A Phase 2 interventional study of ADX-038 and Telitacicept in Immunoglobulin A Nephropathy (IgAN), Complement 3 Glomerulopathy (C3G) and IC-MPGN, sponsored by ADARx Pharmaceuticals, Inc.. Recruiting at 9 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-03.

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

From the registry’s dates

  • Started May 2026; still recruiting 5 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a Phase 2 study to assess the safety, efficacy, pharmacokinetics (PK) and pharmacodynamics of ADX-038 in adults with complement-mediated kidney diseases. The study will enroll Chinese adults with IgA nephropathy, complement 3 glomerulopathy (C3G) and immune complex membranoproliferative glomerulonephritis (IC-MPGN). The study will evaluate ADX-038 administered alone (Part A) and in combination with telitacicept (Part B).

02

Conditions studied

  • Immunoglobulin A Nephropathy (IgAN)
  • Complement 3 Glomerulopathy (C3G)
  • IC-MPGN

Keywords

  • IgAN
  • C3G
  • IC-MPGN
  • complement mediated kidney diseases
  • IgA Nephropathy
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 30 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:

  • Previous kidney transplant or major solid organ transplant
  • Required renal replacement therapy for more than 72 hours
  • Rapidly progressive glomerular nephritis or acute kidney injury
  • History of recurrent invasive infection
  • Current or previous use of C5 or CFB inhibitors (such as eculizumab, ravulizumab or iptacopan)
  • Active TB, or other systemic infection
  • Abnormal liver function
Terms in these criteria, in plain language(3)

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.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

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

Study arms

  • Experimental
    Part A - ADX-038 Monotherapy

    Drug: ADX-038

  • Experimental
    Part B - ADX-038 Combination Therapy

    Drug: ADX-038 · Drug: Telitacicept

Interventions

06

What researchers measure

Primary outcomes

  1. Evaluate the safety and tolerability of ADX-038 as a monotherapy and in combination with telitacicept

    Evaluate the proportion of patients with treatment emergent adverse events (TEAEs) with ADX-038 and telitacicept versus those on ADX-038 alone.

    Time frame: Part A - 24 Months and Part B - 15 months

07

Study locations

9 of 9 sites recruiting
  • ADARx Clinical Site
    Shenzhen, Guangdong 518100, China
    Recruiting
  • ADARx Clinical Site
    Guiyang, Guizhou, China
    Recruiting
  • ADARx Clinical Site
    Zhengzhou, Henan, China
    Recruiting
  • ADARx Clinical Site
    Baotou, Inner Mongolia 014000, China
    Recruiting
  • ADARx Clinical Site
    Wuxi, Jiangsu 214000, China
    Recruiting
  • ADARx Clinical Site
    Yantai, Shandong 264008, China
    Recruiting
  • ADARx Clinical Site
    Beijing, 100034, China
    Recruiting
  • ADARx Clinical Site
    Shandong, China
    Recruiting
  • ADARx Clinical Site
    Shanghai, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2026 (actual). Primary completion is estimated for Jul 2028, 25 months after the start.

Of 41 phase 2 interventional studies under Glomerulonephritis, IGA, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 50. This study's planned 25 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 27, 2026
First posted
Apr 13, 2026
StartActual
May 21, 2026
Primary completionEst.
Jul 10, 2028
CompletionEst.
Jan 21, 2029
Last update
Sep 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07522099
Lead sponsor
ADARx Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Apr 13, 2026
Start date
May 21, 2026
Primary completion
Jul 10, 2028 (estimated)
Completion
Jan 21, 2029 (estimated)
Last update
Sep 3, 2026

Study contacts

Stephanie Leyva
Contact
info@adarx.com
877-232-7974
Arezoo Mirad
study director · ADARx Pharmaceuticals

Oversight

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

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Studies of the drug tested here: ADX-038

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