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New treatment option for Immunoglobulin A Nephropathy (IgAN)
Official title Chinese Adults With Kidney Disease
ClinicalTrials.gov ID: NCT07522099
What this study is testing
What is ADX-038?
ADX-038 is an investigational medicine, being studied as a potential treatment for immunoglobulin a nephropathy (igan).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shenzhen, Guangdong, China
- Guiyang, Guizhou, China
- Zhengzhou, Henan, China
- Baotou, Inner Mongolia, China
- Wuxi, Jiangsu, China
- Yantai, Shandong, China
- Beijing, China
- Shandong, China
- Shanghai, China
- Shangxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenzhen, Guangdong, China; Guiyang, Guizhou, China; Zhengzhou, Henan, China; Baotou, Inner Mongolia, China; Wuxi, Jiangsu, China; Yantai, Shandong, China and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.