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New drug shows promise for kidney disease in early trial

NCT ID NCT05174221

Disease control Sponsor: Takeda Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a drug called mezagitamab in 17 people with IgA nephropathy, a kidney disease. The main goal was to check for side effects and see how the body processes the drug. Participants received injections under the skin for several weeks and were monitored for up to 96 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

17 people

The number who actually took part.

Started

Aug 2022

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 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.

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Conditions

The condition(s) this trial relates to.

glomerulonephritis IgA glomerulonephritis impaired renal function disease kidney disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Glomerulonephritis Kidney disease

Contacts and locations

Locations

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

    Brescia, Lombardy, 25123, Italy

  • Ajou University Hospital

    Suwon, 16499, South Korea

  • Amicis Research Center - Northridge - Nordhoff

    Northridge, California, 91324, United States

  • Beijing Friendship Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100050, China

  • Boise Kidney and Hypertension Institute - Frenova

    Nampa, Idaho, 83687, United States

  • Core Research Group

    Milton, Queensland, 4064, Australia

  • Fujita Health University Hospital

    Toyoake-shi, Aiti, 470-1192, Japan

  • Fundacio Puigvert

    Barcelona, 8025, Spain

  • Guangdong Provincial Peoples Hospital

    Guangzhou, Guangdong, 510080, China

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551, Japan

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Vall d'Hebron - PPDS

    Barcelona, 08035, Spain

  • Hull Royal Infirmary

    Hull, HU3 2JZ, United Kingdom

  • Kasugai Municipal Hospital

    Kasugai-Shi, Aiti, 486-0804, Japan

  • Leicester General Hospital

    Leicester, Leicestershire, LE5 4PW, United Kingdom

  • Monash Health, Monash Medical Centre

    Clayton, Victoria, 3168, Australia

  • National Taiwan University Hospital

    Taipei, 100, Taiwan

  • National University Hospital- Singapore

    Singapore, 119074, Singapore

  • NorthShore University HealthSystem

    Evanston, Illinois, 60201, United States

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • Sapporo City General Hospital

    Sapporo, Hokkaido, 060-8604, Japan

  • Semmelweis Egyetem

    Budapest, 1083, Hungary

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi, 03080, South Korea

  • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, Csongrád megye, 6720, Hungary

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561, Taiwan

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061, China

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