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A Study of Mezagitamab in Adults With Primary IgA Nephropathy Kidney Condition
NCT06963827 · View on ClinicalTrials.gov ↗
Study Summary
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. A placebo looks like medicine but doesn't have any active ingredients in it. Other aims are to check how safe mezagitamab is and how well participants with primary IgAN can tolerate it compared to placebo, and to find out if and how well mezagitamab continues to maintain kidney function over the long term compared to placebo. Participants will be placed in 1 of the 2 treatment groups; the main group and the open-label group. In the main group, participants will be placed in 1 of the 2 treatment groups by chance (either mezagitamab or placebo) at a 2:1 ratio. This means that out of 3 participants, 2 will receive mezagitamab and 1 will receive placebo. The participants will receive either mezagitamab or placebo for almost half a year in two 1-year cycles. They will be observed for another half year in each 1-year cycle and will have check-ups about every month during this time. In the open-label group, a small number of participants who have lower levels of protein in their urine or have kidneys that do not filter the blood well, will receive mezagitamab treatment. This will include participants who have previously received mezagitamab in another study, TAK-079-1006. Every participant will receive mezagitamab in the same way as those in the main group receiving mezagitamab. During the study, participants will visit their study clinic several times.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Mezagitamab
Study Locations (20)
Florida
- South Florida Research Institute — Lauderdale Lakes
- Bioresearch Partners — Miami
- CTR Oakwater, LLC — Orlando
- Bioresearch Partners — Pembroke Pines
Alabama
- UAB Nephrology Research Clinic at Paula Building — Birmingham
- DCR Montgomery — Montgomery
California
- Academic Medical Research Institute — Los Angeles
- University of California Irvine — Orange
Michigan
- Ingham Nephrology & Hypertension, P.C. — Lansing
- Elixia MKC — Pontiac
Missouri
- Elixia MNA — City of Saint Peters
- Clinical Research Consultants a JCCT Company — Kansas City
Texas
- Dallas Renal Group — Dallas
- DCR - El Paso — El Paso
Georgia
- DCR Columbus — Columbus
Idaho
- CARE Institute - Boise Kidney — Boise
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2025-07-15 |
| Est. Completion | 2030-01-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06963827
The ClinicalTrials.gov registry entry for NCT06963827 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 347 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Kidney Disease appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06963827 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06963827 about?
NCT06963827 is a clinical study titled "A Study of Mezagitamab in Adults With Primary IgA Nephropathy Kidney Condition". 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 lo...
What is the current status of trial NCT06963827?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 347 participants. The study started on 2025-07-15. Estimated completion is 2030-01-14.
What conditions does trial NCT06963827 study?
This clinical trial studies the following conditions: Kidney Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06963827?
The interventions under investigation include: Placebo (DRUG), Mezagitamab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06963827?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06963827 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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