Last updated 10 days ago
A Study to Evaluate the Efficacy and Safety of RO7434656 in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
428 patients around the world
Available in Spain, United States
Hoffmann-La Roche
6Research sites
428Patients around the world
This study is for people with
Nephropathy
Iga nephropathy
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Primary IgAN, as evidenced by a kidney biopsy performed within 7 years prior to or during screening, without known secondary cause.Treatment with maximum tolerated doses of angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) for at least 90 days immediately prior to screening.Urine Protein-to-Creatinine Ratio (UPCR) ≥ 1 gram per gram (g/g) or urine protein excretion ≥ 1 gram per day (g/day) (with UPCR ≥ 0.8 g/g), all measured from a 24-hour urine collection during screening obtained no longer than 60 days prior to Day 1.eGFR ≥ 20 mL/min/1.73 m^2, as calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation (Inker et al. 2021a).Female participants of childbearing potential must use adequate contraception.
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 12 weeks after the final dose of RO7434656.Histopathologic or other evidence of another autoimmune glomerular disease.Presence of ≥ 50% crescents on kidney biopsy, sustained doubling of serum creatinine within 3 months prior to screening, or rapidly progressive glomerulonephritis in the opinion of the investigator.Glycated Hemoglobin (HbA1c) ≥ 6.5% or a clinical diagnosis of diabetes mellitus of any type.Uncontrolled blood pressure, in the investigator's assessment, for 3 months prior to screening or during screening.Use of endothelin receptor antagonists, except those approved for use in IgAN.Initiation of mineralocorticoid receptor antagonists or endothelin receptor antagonists within 90 days prior to screening or during screening.Previous treatment with RO7434656.Use of herbal therapies within 90 days prior to or during screening.Treatment with oral or intravenous (IV) corticosteroids with a dose equivalent to ≥ 7.5 milligrams per day (mg/day) of prednisone for 7 days or equivalent to ≥ 5 mg/day of prednisone for 14 days within 90 days prior to screening.Treatment with other immunomodulatory agents within 6 months of randomization including, but not limited to, complement inhibitors, alkylating agents (e.g., cyclophosphamide or chlorambucil), or mycophenolate.Treatment with a calcineurin inhibitor within 2 months prior to screening or during screening.Treatment with anti-CD20 therapy within 9 months of screening or during screening.Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in and completion of the study.Planned major procedure or major surgery during screening or the study.
Sites
Sanatorio Allende (Nueva Córdoba)
Recruiting
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Santa Casa de Misericórdia de Belo Horizonte
Recruiting
Freire Pesquisa Clínica
Recruiting
Hospital de Clínicas de Porto Alegre - HCPA/UFRGS
Recruiting
Hospital das Clínicas da Faculdade de Medicina da São Paulo - USP
Recruiting
StudyIMAGINATION
SponsorHoffmann-La Roche
Conditions
Iga nephropathy
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05797610
