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NCT06963827 · ClinicalTrials.gov registry record · Phase 3

A Study of Mezagitamab in Adults With Primary IgA Nephropathy Kidney Condition

A Phase 3 study of Kidney Disease, sponsored by Takeda.

Recruiting
Registry status
Phase 3
Development phase
347
Enrollment target
20
Study locations

NCT06963827 is a Phase 3 study of Kidney Disease that is actively recruiting participants, run by Takeda. The registered enrollment target is 347 participants, below the 2,925-participant average among 23 other Kidney Disease trials with a reported enrollment target (88% lower). The trial reports 20 study locations across 12 states.

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The verdict

NCT06963827, a Phase 3 study of Kidney Disease, is actively recruiting participants, sponsored by Takeda.

RECRUITING
Registry status
Phase 3
Development phase
347 participants
Enrollment target
20
Study locations

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

Kidney Disease

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

FieldValue
Enrollment Target 347 participants
Start Date 2025-07-15
Est. Completion 2030-01-14
Phase Phase 3

Sponsor

Takeda

408 total trials

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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, categorized as Phase 3. The registered enrollment target is 347 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,925-participant average among 23 other Kidney Disease trials with a reported enrollment target (88% lower). The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.

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.

NCT06963827 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, Alabama, California.

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.

What interventions are being tested in trial NCT06963827?

The interventions under investigation include: Placebo (DRUG), Mezagitamab (DRUG).

Who is sponsoring clinical trial NCT06963827?

This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.

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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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.