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A Study of Mezagitamab in Adults With the Kidney Condition called IgA Nephropathy
EU CTIS ID: 2025-520825-19-00
What this study is testing
To evaluate the effects of mezagitamab on proteinuria levels at Week 36 in participants who are receiving mezagitamab compared with those receiving placebo.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 01. Either urine protein to creatinine ratio (UPCR) ≥0.8 g/g or urine protein excretion (UPE) ≥1 g/day, calculated from aat least one 24-hour urine collection during the screening period (or pre-screening, if applicable) (only applicable for the main trial).
- 02. Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73m2 at screening based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (only applicable for the main trial).
- 03. Renal biopsy supporting diagnosis of primary IgAN within 10 years before consent. A renal biopsy must be performed during screening for participants without a biopsy report within 10 years.
- 04. Resting blood pressure ≤150 mmHg systolic and ≤100 mmHg diastolic.
You likely can't join if
- 01. Kidney biopsy exhibiting significant concomitant renal disease other than IgAN
- 02. Evidence of secondary IgAN and IgA vasculitis.
- 03. Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% eGFR within prior 3 months before consent
- 04. Nephrotic syndrome (24-hr proteinuria >3.5 g/day and hypoalbuminemia (<3.0 g/dL) with or without peripheral edema).
- 05. Immunosuppressant treatment within 6 months of consent.
- 06. Anti-CD20 treatment if either within 6 months of consent or 6-12 months if CD19+ count is
See the full eligibility criteria
- 01. Either urine protein to creatinine ratio (UPCR) ≥0.8 g/g or urine protein excretion (UPE) ≥1 g/day, calculated from aat least one 24-hour urine collection during the screening period (or pre-screening, if applicable) (only applicable for the main trial).
- 02. Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73m2 at screening based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (only applicable for the main trial).
- 03. Renal biopsy supporting diagnosis of primary IgAN within 10 years before consent. A renal biopsy must be performed during screening for participants without a biopsy report within 10 years.
- 04. Resting blood pressure ≤150 mmHg systolic and ≤100 mmHg diastolic.
- 01. Kidney biopsy exhibiting significant concomitant renal disease other than IgAN
- 02. Evidence of secondary IgAN and IgA vasculitis.
- 03. Evidence of rapidly progressive glomerulonephritis (loss of ≥ 50% eGFR within prior 3 months before consent
- 04. Nephrotic syndrome (24-hr proteinuria >3.5 g/day and hypoalbuminemia (<3.0 g/dL) with or without peripheral edema).
- 05. Immunosuppressant treatment within 6 months of consent.
- 06. Anti-CD20 treatment if either within 6 months of consent or 6-12 months if CD19+ count is
- 07. Within 4 months of the screening visist, use of either a) Systemic corticosteroids use at average dose ≥ 40mg prednisone or equivalent or higher for more than 14 days or b) use of oral budesonide delayed release capsules
- 08. Specific infections with respective timeframes
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Argentina
- Brazil
- Singapore
- Australia
- China
- United Kingdom
- Taiwan
- Malaysia
- Hong Kong
- United States
- Turkey
- Japan
- Canada
- Switzerland
- India
- Colombia
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Argentina; Brazil; Singapore; Australia; China and 11 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 EU CTIS; the study team decides eligibility.