ADX-038 with or without telitacicept for Chinese adults with IgA nephropathy, C3G, or IC-MPGN

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study enrolls Chinese adults with biopsy-confirmed IgA nephropathy (IgAN), complement 3 glomerulopathy (C3G), or immune complex membranoproliferative glomerulonephritis (IC-MPGN) who have active kidney disease and eGFR ≥30 mL/min/1.73 m2. Participants will receive ADX-038 alone in Part A or ADX-038 combined with telitacicept in Part B at ADARx clinical sites in China. The trial will collect safety, efficacy, pharmacokinetic, and pharmacodynamic data and monitor kidney function and disease activity over the dosing period. Key exclusions include prior complement inhibitors, prior major organ transplant, prolonged renal replacement therapy, rapidly progressive glomerulonephritis, active systemic infection, and abnormal liver function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Mean eGFR 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 biopsy

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, HIV or other systemic infection
* Abnormal liver function

Where it's running

• ADARx Clinical Site
  Shenzhen, Guangdong, China Recruiting
• ADARx Clinical Site
  Guiyang, Guizhou, China Recruiting
• ADARx Clinical Site
  Zhengzhou, Henan, China Recruiting
• ADARx Clinical Site
  Baotou, Inner Mongolia, China Recruiting
• ADARx Clinical Site
  Wuxi, Jiangsu, China Recruiting
• ADARx Clinical Site
  Yantai, Shandong, China Recruiting

Study contacts

• Study coordinator: Stephanie Leyva
• Email: info@adarx.com
• Phone: 877-232-7974

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• How ARGX-121 affects protein in IgA nephropathy

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• Zigakibart treatment for IgA nephropathy

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• ADX-038 treatment for adults with complement-mediated kidney disease.

  This trial will test whether ADX-038 is safe and helps adults with complement-mediated kidney diseases such as IgA nephropathy, C3G, and IC-MPGN.

  Recruiting at 33 sites Phase 2 ADARx Pharmaceuticals, Inc. · Doral, Florida and 37 other locations · NCT06989359

• Effects of Felzartamab on Adults with Immunoglobulin A Nephropathy

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  Recruiting at 251 sites Phase 3 Biogen · Little Rock, Arkansas and 264 other locations · NCT06935357

• Evaluating iptacopan for treating idiopathic IC-MPGN

  This study is testing if a new medication called iptacopan can help people with a specific kidney condition called idiopathic IC-MPGN feel better by reducing protein in their urine and improving kidney function.

  Recruiting at 125 sites Phase 3 Novartis · Los Angeles, California and 130 other locations · NCT05755386

• Iptacopan for children with primary IgA nephropathy

  This will try oral iptacopan in children aged 2 to <18 with primary IgA nephropathy to lower protein in the urine and check safety.

  Recruiting at 20 sites Phase 3 Novartis · Madera, California and 19 other locations · NCT06994845

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.