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TAK-079-1006
Recruitment Complete

A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy

Clinicaltrials.gov
#NCT05174221
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About this clinical trial

This study will have two parts. The main aims are to: - check the side effects from mezagitamab. - check for long-term side effects from mezagitamab. Before starting the study, participants will be asked to provide a 24-hour urine sample. A few weeks later, if enrolled they will begin receiving a subcutaneous injection (under the skin) of mezagitamab once a week for 8 weeks then once every 2 weeks for 16 weeks. When treatment has ended, there will be a 24-week follow-up period. Participants who receive benefit from the treatment may continue in the second part of the study where they will be monitored for up to 96 weeks and possibly retreated for another 24 weeks.

JP
ES
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8+
Interventional Phase 1 clinical trial.

At a glance

What medical conditions were being studied?

Kidney Disease
Glomerulonephritis

What was the clinical trial testing?

Mezagitamab

How many participants were enrolled?

16

Were placebos part of the clinical trial?

No

When was the clinical trial conducted?

Nov 2022 - Mar 2026

How long was participation in the clinical trial?

Participants could be in the study for almost 3 years, including predosing, treatment, follow-up, and retreatment.

Key requirements

Sex

All

Age

18+ years

Healthy volunteers?

No

Entry criteria

Both men and women can take part.
Must be at least 18 years old.
Must have primary immunoglobulin A nephropathy in the last 10 years and be receiving stable supportive care.
Cannot have used systemic corticosteroids in the last 4 months.
Additional entry criteria will be discussed with the study doctor.

Locations