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COMPLETED
NCT05174221
PHASE1

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

Sponsor: Takeda

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

17

Start Date

2022-08-16

Completion Date

2025-12-15

Last Updated

2026-06-01

Healthy Volunteers

No

Interventions

DRUG

Mezagitamab

TAK-079 subcutaneous injection.

Locations (26)

Amicis Research Center - Northridge - Nordhoff

Northridge, California, United States

Boise Kidney and Hypertension Institute - Frenova

Nampa, Idaho, United States

NorthShore University HealthSystem

Evanston, Illinois, United States

Core Research Group

Milton, Queensland, Australia

Monash Health, Monash Medical Centre

Clayton, Victoria, Australia

Royal Melbourne Hospital

Parkville, Victoria, Australia

Beijing Friendship Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Guangdong Provincial Peoples Hospital

Guangzhou, Guangdong, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont

Szeged, Csongrád megye, Hungary

Semmelweis Egyetem

Budapest, Hungary

ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

Brescia, Lombardy, Italy

Kasugai Municipal Hospital

Kasugai-Shi, Aiti, Japan

Fujita Health University Hospital

Toyoake-shi, Aiti, Japan

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Sapporo City General Hospital

Sapporo, Hokkaido, Japan

National University Hospital- Singapore

Singapore, Singapore

Seoul National University Hospital

Seoul, Seoul Teugbyeolsi, South Korea

Ajou University Hospital

Suwon, South Korea

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, Spain

Fundacio Puigvert

Barcelona, Spain

Taipei Medical University Shuang Ho Hospital

New Taipei City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Leicester General Hospital

Leicester, Leicestershire, United Kingdom

Hull Royal Infirmary

Hull, United Kingdom