AzTrials
AzTrials

Kidney DiseasePhase 1NCT05174221

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

A Phase 1 study testing Mezagitamab in people with Kidney Disease and Glomerulonephritis, run by Takeda at 26 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Disease, Glomerulonephritis
What is being tested?
Mezagitamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
26 sitesin 11 countries
Study dates
16 Aug 2022to 15 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Renal biopsy report supporting diagnosis of primary IgAN or IgA vasculitis-associated nephritis within 10 years prior to the screening visit.
  • 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.
  • Estimated glomerular filtration rate (eGFR) >=45 milliliter per minute per 1.73 square meter (mL/min/1.73m^2) at screening.
  • 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.

Who cannot join

  • Kidney biopsy confirming significant renal disease other than IgAN.
  • Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies).
  • Evidence of rapidly progressive glomerulonephritis (loss of >=50 percent (%) of eGFR within 3 months prior to the screening visit).
  • 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.
  • 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.
  • 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.
Show all 17Show fewer
  • 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.
  • 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.
  • 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.
  • 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.
  • A positive T-cell interferon-gamma release assay (TIGRA) (result through QuantiFERON-TB Gold test or T-Spot/Elispot) at the screening visit.
  • 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.
  • Inadequate organ and bone marrow function at screening visit.
  • Presence of uncontrolled or New York Heart Association (NYHA 1994) Class 3 or 4 congestive heart failure at the screening visit.
  • Uncontrolled diabetes manifested by glycosylated hemoglobin (HbA1c) >8% at the screening visit.
  • 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.

Trial locations and contacts

26 sites in 11 countries.

26 sites in 11 countries

Japan4 sites

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Kasugai Municipal Hospital

    Kasugai-Shi, Aiti, 486-0804

  • Sapporo City General Hospital

    Sapporo, Hokkaido, 060-8604

  • Fujita Health University Hospital

    Toyoake-shi, Aiti, 470-1192

Other trials in Japan

United States3 sites

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201

  • Boise Kidney and Hypertension Institute - Frenova

    Nampa, Idaho, 83687

  • Amicis Research Center - Northridge - Nordhoff

    Northridge, California, 91324

Other trials in United States

Australia3 sites

  • Monash Health, Monash Medical Centre

    Clayton, Victoria, 3168

  • Core Research Group

    Milton, Queensland, 4064

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

Other trials in Australia

China3 sites

  • Beijing Friendship Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

Other trials in China

Spain3 sites

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035

  • Fundacio Puigvert

    Barcelona, 8025

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008

Other trials in Spain

Hungary2 sites

  • Semmelweis Egyetem

    Budapest, 1083

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, Csongrád megye, 6720

Other trials in Hungary

South Korea2 sites

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080

  • Ajou University Hospital

    Suwon, 16499

Other trials in South Korea

Taiwan2 sites

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561

  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

United Kingdom2 sites

  • Hull Royal Infirmary

    Hull, HU3 2JZ

  • Leicester General Hospital

    Leicester, Leicestershire, LE5 4PW

Other trials in United Kingdom

Italy1 site

  • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

    Brescia, Lombardy, 25123

Other trials in Italy

Singapore1 site

  • National University Hospital- Singapore

    Singapore, 119074

Other trials in Singapore

About this study

Official title: A Phase 1b, Multicenter, Open-Label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Mezagitamab (TAK-079) in Patients With Primary IgA Nephropathy in Combination With Stable Background Therapy

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.

Being tested
Mezagitamab
Keywords
Drug Therapy
Medical subject headings
Kidney Diseases, Glomerulonephritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MezagitamabDrug

    Also called TAK-079

    TAK-079 subcutaneous injection.

Study groups in NCT05174221
Study groupRoleWhat they receive
MezagitamabExperimentalMezagitamab, 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.
Receives: Drug: Mezagitamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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.

    Measured: Retreatment Week 0 to 48

Secondary outcomes (8)

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

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

  2. Main Study: Serum IgA Levels

    Measured: 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).

    Measured: 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.

    Measured: Up to Week 48

  5. LTE Observation Period: Serum IgA Levels

    Measured: 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).

    Measured: Up to Week 96

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

    Measured: 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.

    Measured: Up to Retreatment Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2021
  2. Study start16 Aug 2022
  3. Primary completion15 Dec 2025
  4. Study completion15 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05174221
Sponsor's protocol ID
TAK-079-1006
Other IDs
2024-516743-34-00, jRCT2011220009
Status last verified
May 2026
First submitted
14 Dec 2021
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Mezagitamab in people with Kidney Disease and Glomerulonephritis, run by Takeda at 26 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in Japan, United States, Australia, China, Spain and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Up to Week 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05174221, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in