A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy
NCT05174221 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 17
Last updated 2026-01-26
Summary
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.
Conditions
Interventions
- DRUG
-
Mezagitamab
TAK-079 subcutaneous injection.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Study Director · Takeda
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-09
- Primary Completion
- 2025-12-15
- Completion
- 2025-12-15
- FDA Drug
- Yes
Countries
- United States
- Australia
- China
- Hungary
- Italy
- Japan
- Singapore
- South Korea
- Spain
- Taiwan
- United Kingdom
Study Locations
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