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

Conditions

• Kidney Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Mezagitamab — DRUG
  Mezagitamab injections administered SC.
• Placebo — DRUG
  Mezagitamab-matching placebo injections administered SC.

Study Details

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.

Key Dates

Start date

Jul 15, 2025

Status verified

Jun 2026

Primary completion

Sep 7, 2028

Completion

Jan 14, 2030

Study Design

Enrollment

347 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Mezagitamab
  Participants will receive mezagitamab injections, subcutaneously (SC), for approximately 22 weeks in each 52-week period.
• Placebo Comparator: Placebo
  Participants will receive mezagitamab-matching placebo injections, SC for approximately 22 weeks in each 52-week period.
• Experimental: Open-label Mezagitamab
  Participants will receive mezagitamab injections, SC for approximately 22 weeks in each 52-week period.

Primary Outcome Measure

Change from Baseline in Proteinuria at Week 36 [ Time Frame: From Baseline to Week 36 ]

Central Contacts

• Takeda Contact
  +1-877-825-3327
  [email protected]

Locations (40)

Find similar trials in Birmingham, AL

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