Visionary Trial

Immunoglobulin A nephropathy (IgAN), is a common form of glomerulonephritis and a leading cause of chronic kidney disease (CKD) worldwide. Despite standard care with angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), many patients progress to kidney failure. Sibeprenlimab, a novel subcutaneous therapy, is being evaluated for its potential to reduce proteinuria and preserve kidney function in IgAN patients.

The VISIONARY trial is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of sibeprenlimab. It is sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. and is conducted across more than 20 countries worldwide in 484 participants, including 20 patients from Sri Lanka.

The primary aim of the VISIONARY study is to evaluate the effect of sibeprenlimab versus placebo on urinary protein to creatinine ratio (uPCR) at 9 months, a key marker of kidney damage and disease progression in IgAN.

Sri Lankan Sites include:

• Sri Jayewardenepura General Hospital

• National Hospital of Sri Lanka

• National Hospital, Kandy

• Kurunegala Teaching Hospital

• Karapitiya Teaching Hospital

Dr. Chula Herath, Consultant Nephrologist at the Sri Jayewardenepura General Hospital was the Coordinating Principal Investigator of the study in Sri Lanka.

Recruitment is complete and follow-up is ongoing. First participant enrollment in Sri Lanka occurred on January 31, 2023.

The interim analysis of the VISIONARY Phase 3 trial demonstrated a significant 51.2% reduction in proteinuria in patients treated with sibeprenlimab compared to placebo. These findings strongly support the effectiveness of sibeprenlimab and reinforce confidence in its potential, especially within the largest Phase 3 clinical trial conducted to date for IgA nephropathy.

Find more information about the trial: ClinicalTrials.gov ID: NCT05248646

Stay tuned for updates as the Visionary trial progresses.