Immunoglobulin A Nephropathy
Conditions
Interventions
Study Sites:
• Sri Jayewardenepura General Hospital
• National Hospital of Sri Lanka
• National Hospital, Kandy
• Kurunegala Teaching Hospital
• Karapitiya Teaching Hospital
Intervention:
This
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects who completed Trial 417-201-00007;NCT05248646 (at least 20 of the 26 doses and the end-of-trial visit) or Trial VIS649-201;NCT04287985 (at least 9 of the 12 doses and the end-of-trial visit) without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab for IgAN 2. eGFR >20 mL/min/1.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
Exclusion criteria
Exclusion criteria: 1. Subjects who have not completed participation in trials 417-201-00007 or VIS649-201. 2. Subjects with treatment-limiting adverse events (AEs) during Trials 417-201-00007 or VIS649-201 considered related to IMP per investigator judgement that would preclude rollover into this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Treatment-emergent adverse events (TEAEs) graded by severity and as assessed by clinical laboratory tests (mentioned below), vital sign measurements, physical examinations, and injection site reactions. TEAEs are all Adverse Effects which started after the start of IMP treatment: or if the event was continuous from baseline and was worsening, serious, IMP-related, or resulted in death, discontinuation, interruption, or reduction of IMP. Hematology: Basophils (percentage and absolute count) Eosinophils (percentage and absolute count) Hematocrit Hemoglobin Lymphocytes (percentage and absolute count) Mean corpuscular hemoglobin Mean corpuscular hemoglobin concentration Mean corpuscular volume Monocytes (percentage and absolute count) Neutrophils (percentage and absolute count) Platelet count Red blood cell count Red blood cell distribution width White blood cell count Urinalysis: Bilirubin Blood Creatinine Glucose Ketones Leukocytes Nitrite pH and specific gravity Protein Urobilinogen Microscopic (only for abnormal urine stick test findings) Serum Chemistry: Albumin Alkaline phosphatase ALT AST Calcium Chloride Total cholesterol Creatinine Gamma glutamyl transferase eGFR (calculated using the CKD-EPI equation) Glucose HbA1c Lactate dehydrogenase Phosphorus Potassium Sodium Total bilirubin Total protein Triglycerides Uric acid Viral Serology: HBsAb HBsAg Hepatitis C virus antibody HBcAb HIV enzyme-linked immunosorbent assay Other Tests Hepatitis B virus DNA for subjects with isolated HBcAb Pregnancy test: serum/urine beta human chorionic gonadotropin (subjects of childbearing potential only) [Baseline and end-of-trial visit in Week 112] | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Annualized slope of Estimated Glomerular Filtration Rate (eGFR) 2. Urine protein/creatinine ratio (uPCR) in a 24-hour collection 3. Proportion of Subjects with Clinical Remission as defined in the protocol 4. Time to Progression of Chronic Kidney Disease, as defined in the protocol (available to download under supporting documents) [1. Annualized slope of Estimated Glomerular Filtration Rate (eGFR) [ Time Frame: Over 12 and 24 months ] 2. Urine protein/creatinine ratio (uPCR) in a 24-hour collection [ Time Frame: At 12 and 24 months ] 3. Proportion of Subjects with Clinical Remission as defined in the protocol [ Time Frame: At 12 and 24 months ] 4. Time to Progression of Chronic Kidney Disease, as defined in the protocol [ Time Frame: Over 24 months ]] | — |
Countries
Argentina,Australia,Brazil,Canada,China,Czech Republic,France,Germany,Hong Kong,India,Israel,Italy,Japan,Korea, Republic of,Malaysia,Netherlands,Philippines,Poland,Portugal,Singapore,Spain,Sri Lanka,T
Contacts
Public ContactDr Chinthana Galahitiyawa
Consultant Nephrologist
Outcome results
None listed