Last updated 6 months ago
Trial of the Impact of Sibeprenlimab on Immunoglobulin A Nephropathy Kidney Tissue
25 patients around the world
Available in United States, Argentina
Otsuka Pharmaceutical Development & Commercialization, Inc.
3Research sites
25Patients around the world
This study is for people with
Nephropathy
Iga nephropathy
Requirements for the patient
From 16 Years
All Gender
Medical requirements
- Participants must be at least 16 years of age or older at the time of signing the informed consent/assent.Source-verified kidney biopsy confirmed diagnosis of IgAN.Participant has estimated glomerular filtration rate (eGFR) > 45 mL/min/1.73 m2 using serum creatinine (Chronic Kidney Disease-Epidemiology Collaboration [CKD EPI] creatinine eGFR 2021 equation for those 18 years and older; Chronic Kidney Disease in Children under age 25 [CKiD U25] eGFR equation for those younger than 18 years).
- Participants who are breast-feeding and/or who have a positive pregnancy test result prior to receiving sibeprenlimab.Participant has coexisting chronic kidney disease, other than IgAN.Participant has a serum IgG value <600 mg/dL at screening.Participant is currently receiving or has received within 24 weeks prior to the first dose of sibeprenlimab, systemic corticosteroids or immunosuppression.Participant has uncontrolled hypertension (defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg).Participants who would be likely to require prohibited concomitant therapy during the trial.
Sites
Hospital Británico de Buenos Aires - CABA
Recruiting
Investigación Clínica Aplicada S.R.L.
Recruiting
Clínica Privada Vélez Sarsfield - Córdoba
Recruiting
SponsorOtsuka Pharmaceutical Development & Commercialization, Inc.
Study typeInterventional
Conditions
Iga nephropathy
Requirements
From 16 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06740526
