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Phase 2b Open-Label Repeat Kidney Biopsy Study
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Summary
Assess impact of sibeprenlimab on IgA deposition and other histological endpoints in kidney tissue at Week 52 relative to baseline
Official title: A Phase 2b, Multicenter, Open-label, Single-arm Trial to Evaluate the Impact of Sibeprenlimab on Kidney Histopathology Through Repeat Kidney Biopsies Adults With Immunoglobulin A Nephropathy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2024-12-05
Completion Date
2028-12-28
Last Updated
2026-10-27
Healthy Volunteers
No
Conditions
Interventions
Sibeprenlimab
Sibeprelimab SC (Period 1) Sibeprelimab SC (Period 2)
Locations (19)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Stanford University Medical Center
Stanford, California, United States
Colorado Kidney Care PC
Denver, Colorado, United States
Massachusetts General Hospital (MGH) Harvard
Boston, Massachusetts, United States
Dakota Dunes
Dakota Dunes, South Dakota, United States
Prolato Clinical Research Center
Houston, Texas, United States
Hospital Britanco de Buenos Aires
Buenos Aires, Argentina
Centro Medico Dra Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Argentina
St. Paul's Hospital
Vancouver, British Columbia, Canada
Hamilton Centre for Kidney Research (HCKR)
Hamilton, Ontario, Canada
OTT Healthcare
Scarborough Village, Ontario, Canada
Juntendo University - Urayasu Hospital
Urayasu, Chiba, Japan
Kobe University Hospital
Kobe, Hyōgo, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Kyushu University Hospital
Fukuoka, Japan
University of Miyazaki Hospital
Miyazaki, Japan
Juntendo University Hospital
Tokyo, Japan
Leicester General Hospital
Leicester, United Kingdom
King's College Hospital NHS Foundation Trust
London, United Kingdom