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NCT05174221CompletedPhase 1

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

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

Source: ClinicalTrials.gov · Last updated 1 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
17 (actual)
First submitted
14 Dec 2021
Start date
16 Aug 2022
Primary completion date
15 Dec 2025
Lead sponsor
Takeda
NCT number
NCT05174221
EU CT number
2024-516743-34-00
EudraCT number
2021-005023-20

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 17
  • From 16 Aug 2022 to the primary completion date, 15 Dec 2025
  • 23 sites in 11 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • 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.

Other illness

  • Kidney biopsy confirming significant renal disease other than IgAN.
  • Secondary IgAN (such as with significant liver disease, inflammatory bowel disease, and seronegative spondyloarthropathies).
  • 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.
  • Presence of uncontrolled or New York Heart Association (NYHA 1994) Class 3 or 4 congestive heart failure 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.

Lab values

  • 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.
  • Uncontrolled diabetes manifested by glycosylated hemoglobin (HbA1c) \>8% at the screening visit.

Other

  • A positive T-cell interferon-gamma release assay (TIGRA) (result through QuantiFERON-TB Gold test or T-Spot/Elispot) at the screening visit.
  • Inadequate organ and bone marrow function at screening visit.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (23)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Monash Health (Monash Medical Centre)
Coordinator of this site? Confirm its status
ClaytonAustraliaUnknown status
Core Research Group
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MiltonAustraliaUnknown status
Royal Melbourne Hospital
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ParkvilleAustraliaUnknown status
Beijing Friendship Hospital, Capital Medical University
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BeijingChinaUnknown status
Guangdong Provincial Peoples Hospital
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GuangzhouChinaUnknown status
The First Affiliated Hospital of Xi'an Jiaotong University
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Xi’anChinaUnknown status
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hull Royal Infirmary
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HullUnited KingdomUnknown status
Leicester General Hospital
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LeicesterUnited KingdomUnknown status
Semmelweis University
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Budapest VIIIHungaryCompleted
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
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BresciaItalyUnknown status
Hiroshima University Hospital
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HiroshimaJapanUnknown status
Kasugai Municipal Hospital
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Kasugai-shiJapanUnknown status
Sapporo City General Hospital
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SapporoJapanUnknown status
Fujita Health University Hospital
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Toyoake-shiJapanUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Ajou University Hospital
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SuwonSouth KoreaUnknown status
National University Hospital Singapore
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SingaporeSingaporeUnknown status
Taipei Medical University Shuang Ho Hospital
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New Taipei CityTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
NorthShore University HealthSystem
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EvanstonUnited StatesUnknown status
Boise Kidney and Hypertension Institute - Frenova
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NampaUnited StatesUnknown status
Amicis Research Center - Northridge - Nordhoff
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NorthridgeUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.