NCT06963827 · Takeda
A Study of Mezagitamab in Adults With Primary IgA Nephropathy Kidney Condition
What this study is about
Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly.
View original scientific description
Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the body's immune system creates groups of proteins (called immune complexes) that build-up in the kidneys causing swelling (inflammation). Over time, this inflammation may lead to kidney damage and cause the kidneys to no longer work properly. The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN.
Interventions
DRUG
Mezagitamab
Mezagitamab injections administered SC.
DRUG
Placebo
Mezagitamab-matching placebo injections administered SC.
Primary outcome measures
Change from Baseline in Proteinuria at Week 36
Time frame: From Baseline to Week 36
Proteinuria will be assessed by urine protein to creatinine ratio (UPCR) calculated from a 24-hour urine collection.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- To be eligible to participate in this trial, an individual must meet all the following criteria: 1. Either UPCR greater than or equal to (≥) 0.8 gram per gram (g/g) or urine protein excretion (UPE) ≥1 grams per day (g/day), calculated from a 24-hour urine collection during the screening period (only applicable for the main group). 2. eGFR greater than (\>)30 milliliters per minute per 1.73 meter square (mL/min/1.73m\^2) at screening based on the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (only applicable for the main group). 3. No prior exposure to anti- cluster of differentiation 38 (CD38) therapy period (only applicable for the main group). 4. The participant is at least aged 18 years or the local legal age if greater than 18 years, inclusive. 5. The participant (and the participant's legally acceptable representative, if applicable per local regulations or determination) has provided informed consent (that is, in writing, documented v
Where
- Birmingham, Alabama
- Montgomery, Alabama
- Surprise, Arizona
- Fremont, California
- Los Angeles, California
- Orange, California
- Jacksonville, Florida
- Lauderdale Lakes, Florida
- Melbourne, Florida
- Miami, Florida
- Orlando, Florida
- Pembroke Pines, Florida
And 26 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations