A Phase 1 interventional study of Mezagitamab in Kidney Disease and Glomerulonephritis, sponsored by Takeda. Completed at 26 sites in 11 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by Takeda · Phase 1, Interventional, and Treatment
This study will have two parts. The main aims are to:
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.
The drug being tested in this study is called mezagitamab. Mezagitamab is being tested for the first time in this patient population and might help to treat people who have Primary Immunoglobulin (IgA) Nephropathy. This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of mezagitamab in combination with stable background therapy.
The study will enroll approximately 16 participants. The study will consist of 2 key components: a main study and a long-term extension (LTE) study, which includes an observation period and a retreatment period. The observation period of the LTE study is a non-interventional study segment and the retreatment period of the LTE study consists of a redosing period in which participants will be administered mezagitamab at the same dose level as in the main study. Only participants who have a positive outcome during the main study will enter LTE study.
Participants will be enrolled to the following cohort:
This multi-center trial will be conducted in the United States, Europe, and Asia Pacific. The overall time to participate in this study is approximately 154 weeks.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 17 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
Browse Kidney Diseases studies →Takeda is the lead sponsor of 1,002 studies on the registry; 92 are open to participants now.
Of its 173 completed or terminated interventional studies of FDA-regulated products, 149 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Use of systemic corticosteroids within 4 months from screening visit or expected use for the duration of the study.
Use of B-cell-directed biologic therapies such as blisibimod, belimumab, rituximab, ocrelizumab or have used other biologics (example, anti-tumor necrosis factor [TNF], abatacept, anti-interleukin [IL]-6) within 6 months prior to the screening visit or expected use of any of these agents for the duration of the study.
Mezagitamab, subcutaneous injection, once weekly for 8 weeks then once every 2 weeks for 16 weeks in the Main Study. Same dosing regimen will be repeated in LTE Retreatment Period.
Drug: Mezagitamab
TAK-079 subcutaneous injection.
Also known as: TAK-079
Main Study: Percentage of Participants With one or More Treatment-emergent Adverse Events (TEAEs), Grade 3 or Higher TEAEs, Serious Adverse Events (SAEs), and Adverse Events (AEs) Leading to Mezagitamab Discontinuation
The severity of TEAEs will be graded using National cancer institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Time frame: Up to Week 48
LTE Observation Period: Percentage of Participants With one or More TEAEs, Grade 3 or Higher TEAEs and SAEs
The severity of TEAEs will be graded using NCI-CTCAE version 5.0.
Time frame: Up to Week 96
LTE Retreatment Period: Percentage of Participants With one or More TEAEs, SAEs, Grade 3 or Higher TEAEs and AEs leading to Mezagitamab Discontinuation
The severity of TEAEs will be graded using NCI-CTCAE version 5.0.
Time frame: Retreatment Week 0 to 48
Main Study: Ctrough: Observed Serum Trough Concentrations of Mezagitamab
Time frame: Week 0 Pre-dose and at multiple time points (up to Week 48)
Main Study: Serum IgA Levels
Time frame: Week 0 Pre-dose and at multiple time points (up to Week 48)
Main Study: Percent Change From Baseline in Proteinuria Based on Urine Protein to Creatinine Ratio (UPCR)
UPCR is calculated by dividing the concentration of protein (milligram per deciliter \[mg/dL\]) in urine by the urine creatinine concentration (mg/dL).
Time frame: Week 36
Main Study: Percentage of Participants Based on Antidrug Antibody (ADA) Levels in Serum
Percentage of participants in each category of the immunogenicity status (ADA-negative, ADA-positive and titer) will be determined in this study.
Time frame: Up to Week 48
LTE Observation Period: Serum IgA Levels
Time frame: Week 56 Pre-dose and at multiple time points (up to Week 96)
LTE Observation Period: Percent Change From Baseline in Proteinuria Based on UPCR
UPCR is calculated by dividing the concentration of protein (mg/dL) in urine by the urine creatinine concentration (mg/dL).
Time frame: Up to Week 96
LTE Observation Period: Percentage of Participants Based on ADA Levels in Serum
Time frame: Up to Week 96
LTE Retreatment Period: Percentage of Participants Based on ADA Levels in Serum
Percentage of participants in each category of the immunogenicity status (ADA-negative, ADA-positive and titer) will be determined in this study.
Time frame: Up to Retreatment Week 48
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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