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NCT05174221 | ACTIVE NOT RECRUITING | Kidney Disease

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

Takeda

Brief 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.

Condition or disease

Kidney Disease

Glomerulonephritis

Intervention/treatment

Mezagitamab

Phase

PHASE1

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 16 participants
Masking : NONE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2022-11-09
Estimated Primary Completion Date : 2026-03-23
Estimated Study Completion Date : 2026-03-23

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
A Study of Mezagitamab in Adults With Primary Immunoglobulin A Nephropathy Receiving Stable Background Therapy

Location Details

NCT05174221

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

United States, California

Amicis Research Center - Northridge - Nordhoff

Northridge, California, United States, 91324

Not yet recruiting

United States, Idaho

Boise Kidney and Hypertension Institute - Frenova

Nampa, Idaho, United States, 83687

Not yet recruiting

United States, Illinois

NorthShore University HealthSystem

Evanston, Illinois, United States, 60201

Not yet recruiting

Australia, Queensland

Core Research Group

Milton, Queensland, Australia, 4064

Not yet recruiting

Australia, Victoria

Monash Health, Monash Medical Centre

Clayton, Victoria, Australia, 3168

Not yet recruiting

Australia, Victoria

Royal Melbourne Hospital

Parkville, Victoria, Australia, 3050

Not yet recruiting

China, Beijing

Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing, China, 100050

Not yet recruiting

China, Guangdong

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China, 510080

Not yet recruiting

China, Shaanxi

The First Affiliated Hospital of Xi'an Jiaotong University

Xian, Shaanxi, China, 710061

Not yet recruiting

Hungary, Cuddly

Szeged Science University Albert Szent-Gyorgyi Clinical Center

Szeged, Csongrad, Hungary, 6720

Not yet recruiting

Hungary,

Semmelweis University

Budapest, Hungary, 1083

Not yet recruiting

Italy, Lombardy

ASST of the Civil Spedali di Brescia - Civil Spedali di Brescia

Brescia, Lombardy, Italy, 25123

Not yet recruiting

Japan, It was

Kasugai Municipal Hospital

KA Suga-shi, He said, Japan, 486-0804

Not yet recruiting

Japan, It was

Fujita Health University Hospital

Mr. Toyoaki, He said, Japan, 470-1192

Not yet recruiting

Japan, Hiroshima

Hiroshima University Hospital

I'm excited, Hiroshima, Japan, 734-8551

Not yet recruiting

Japan, Hokkaido

Sapporo City General Hospital

Mr. Sapporo, Hokkaido, Japan, 060-8604

Not yet recruiting

Korea, Republic of, Seoul Teugbyeolsi

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, Korea, Republic of, 03080

Not yet recruiting

Korea, Republic of,

University Hospital upgrade

Slop, Korea, Republic of, 16499

Not yet recruiting

Singapore,

National University Hospital- Singapore

Singapore, Singapore, 119074

Not yet recruiting

Spain, Sneaky

Marques de Valdecilla University Hospital

Santander, Cantabria, Spain, 39008

Not yet recruiting

Spain,

Vall d'Hebron University Hospital - PPDS

Barcelona, Spain, 08035

Not yet recruiting

Spain,

Puigvert Fundacio

Barcelona, Spain, 8025

Not yet recruiting

Taiwan,

Taipei Medical University Shuang ho hospital hospital hospital hospital

New Taipei City, Taiwan, 23561

Not yet recruiting

Taiwan,

National Taiwan University Hospital

Taipei, Taiwan, 100

Not yet recruiting

United Kingdom, Leicestershire

Leicester General Hospital

Leicester, Leicestershire, United Kingdom, LE5 4PW

Not yet recruiting

United Kingdom,

Hull Royal Infirmary

Hull, United Kingdom, HU3 2JZ