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CompletedNCT05174221Updated Jun 1, 2026

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

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

Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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:

  • Mezagitamab

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.

02

Conditions studied

  • Kidney Disease
  • Glomerulonephritis

Keywords

  • Drug Therapy
03

In context

Kidney Diseases

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 →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Renal biopsy report supporting diagnosis of primary IgAN or IgA vasculitis-associated nephritis within 10 years prior to the screening visit.
  2. UPCR greater than or equal to (>=) 1 milligram per milligram (mg/mg) or urine protein excretion (UPE) >=1 gram per day (g/day) by 24-hour urine collection during the screening period.
  3. Estimated glomerular filtration rate (eGFR) >=45 milliliter per minute per 1.73 square meter (mL/min/1.73m\^2) at screening.
  4. Receiving stable background therapy for IgAN (angiotensin-converting enzyme inhibitor [ACE-I] or angiotensin receptor blocker [ARB]) for 12 weeks prior to screening. The ACE-I and ARB dose should represent the maximum tolerated or maximum labeled dose, as determined by the investigator, for a minimum of 3 months and remain stable during the entire duration of the study.

Exclusion criteria

Exclusion Criteria:

  1. Kidney biopsy confirming significant renal disease other than IgAN.
  2. Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies).
  3. Evidence of rapidly progressive glomerulonephritis (loss of >=50 percent (%) of eGFR within 3 months prior to the screening visit).
  4. Diagnosis of nephrotic syndrome defined as 24-hour proteinuria greater than (>) 3.5 g/day, hypoalbuminemia (smaller than [\<] 30 g/L) with or without peripheral edema at the screening visit.
  5. Diagnosis of acute active extrarenal IgA vasculitis (Henoch-Schönlein purpura) manifested by the involvement of other organs (palpable purpura, abdominal pain, and arthritis) at the screening visit and within 1 year prior to the screening visit.
  6. Previous treatment with immunosuppressive agents such as cyclophosphamide, mycophenolate mofetil (MMF), cyclosporine, azathioprine, calcineurin inhibitors within 6 months prior to the screening visit or expected use of any of these agents for the duration of the study.
  7. 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.

  8. Participation in another investigational study within 4 weeks or 5 half-lives of study drug, whichever is longer, before the screening visit (the 4-week window is derived from the date of the last study procedure, and/or AE related to the study procedure in the previous study, to the screening visit of the current study) or expected use of an investigational agent from another investigational study during the time of this study.
  9. Administration of any vaccine within 28 days before the screening visit or of any live or live-attenuated vaccination planned for the duration of the study.
  10. An opportunistic infection smaller than or equal to (\<=) 12 weeks before screening visit or currently receiving treatment for a chronic opportunistic infection, such as tuberculosis (TB), pneumocystis pneumonia, cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria. A mild, localized herpes simplex infection within 12 weeks of study dosing is allowed, as long as the lesion has resolved prior to Day 1.
  11. A positive T-cell interferon-gamma release assay (TIGRA) (result through QuantiFERON-TB Gold test or T-Spot/Elispot) at the screening visit.
  12. A positive test result for hepatitis B surface antigen, or hepatitis B core antibody, or hepatitis C antibody, or HIV antibody/antigen at screening. However, an individual who has a known history of chronic hepatitis C and has been treated and fully cured of the disease, confirmed with a negative hepatitis C virus RNA polymerase chain reaction (PCR) test at screening, is not excluded on the basis of the positive hepatitis C antibody alone.
  13. Inadequate organ and bone marrow function at screening visit.
  14. Presence of uncontrolled or New York Heart Association (NYHA 1994) Class 3 or 4 congestive heart failure at the screening visit.
  15. Uncontrolled diabetes manifested by glycosylated hemoglobin (HbA1c) >8% at the screening visit.
  16. Current malignancy or history of malignancy during the previous 5 years, except adequately treated basal cell or squamous cell carcinomas of the skin or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • Experimental
    Mezagitamab

    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

Interventions

  • DrugMezagitamab

    TAK-079 subcutaneous injection.

    Also known as: TAK-079

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Main Study: Ctrough: Observed Serum Trough Concentrations of Mezagitamab

    Time frame: Week 0 Pre-dose and at multiple time points (up to Week 48)

  2. Main Study: Serum IgA Levels

    Time frame: Week 0 Pre-dose and at multiple time points (up to Week 48)

  3. 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

  4. 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

  5. LTE Observation Period: Serum IgA Levels

    Time frame: Week 56 Pre-dose and at multiple time points (up to Week 96)

  6. 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

  7. LTE Observation Period: Percentage of Participants Based on ADA Levels in Serum

    Time frame: Up to Week 96

  8. 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

07

Study locations

26 sites
  • Amicis Research Center - Northridge - Nordhoff
    Northridge, California 91324, United States
  • Boise Kidney and Hypertension Institute - Frenova
    Nampa, Idaho 83687, United States
  • NorthShore University HealthSystem
    Evanston, Illinois 60201, United States
  • Core Research Group
    Milton, Queensland 4064, Australia
  • Monash Health, Monash Medical Centre
    Clayton, Victoria 3168, Australia
  • Royal Melbourne Hospital
    Parkville, Victoria 3050, Australia
  • Beijing Friendship Hospital,Capital Medical University
    Beijing, Beijing Municipality 100050, China
  • Guangdong Provincial Peoples Hospital
    Guangzhou, Guangdong 510080, China
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shaanxi 710061, China
  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
    Szeged, Csongrád megye 6720, Hungary
  • Semmelweis Egyetem
    Budapest, 1083, Hungary
  • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
    Brescia, Lombardy 25123, Italy
  • Kasugai Municipal Hospital
    Kasugai-Shi, Aiti 486-0804, Japan
  • Fujita Health University Hospital
    Toyoake-shi, Aiti 470-1192, Japan
  • Hiroshima University Hospital
    Hiroshima, Hiroshima 734-8551, Japan
  • Sapporo City General Hospital
    Sapporo, Hokkaido 060-8604, Japan
  • National University Hospital- Singapore
    Singapore, 119074, Singapore
  • Seoul National University Hospital
    Seoul, Seoul Teugbyeolsi 03080, South Korea
  • Ajou University Hospital
    Suwon, 16499, South Korea
  • Hospital Universitario Marques de Valdecilla
    Santander, Cantabria 39008, Spain
  • Hospital Universitario Vall d'Hebron - PPDS
    Barcelona, 08035, Spain
  • Fundacio Puigvert
    Barcelona, 8025, Spain
  • Taipei Medical University Shuang Ho Hospital
    New Taipei City, 23561, Taiwan
  • National Taiwan University Hospital
    Taipei, 100, Taiwan
  • Leicester General Hospital
    Leicester, Leicestershire LE5 4PW, United Kingdom
  • Hull Royal Infirmary
    Hull, HU3 2JZ, United Kingdom
08

References and documents

Publications

  • Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772. PubMed 40465397 ↗
  • Mayer KA, Budde K, Diebold M, Halloran PF, Bohmig GA. Targeting CD38 in Antibody-Mediated Rejection. Transpl Int. 2025 May 15;38:14343. doi: 10.3389/ti.2025.14343. eCollection 2025. PubMed 40444214 ↗

Individual participant data

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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05174221
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Dec 30, 2021
Start date
Aug 16, 2022
Primary completion
Dec 15, 2025
Completion
Dec 15, 2025
Last update
Jun 1, 2026

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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