Date

2021-06-21

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

In Sri Lanka, this study will be conducted at the following centers • Sri Jayawardenapura General Hospital • National Hospital of Sri Lanka. Randomization will be a stratified randomization. All eligible participants will be centrally assigned to randomized study intervention using an Interactive Voice/Web Response System (IVRS/IWRS). Participants will be randomly assigned in a 1:1:1:1 allocation ratio to receive VIS649 at 2, 4, or 8 mg/kg or placebo, with approximately 36 participants randomized to each intervention group. VIS649 will be intravenously (IV) administered monthly over a 12-month treatment course in participants with IgAN. VIS649 will be administered as a mg/kg dosage determined by dose assigned at time of randomization. VIS649 will be administered IV over 1 hour, in a single, final volume 100 mL infusion in normal saline (0.9% NaCl). Dosage frequency is once a month for a period of 12 months. Control group will be receiving normal saline (0.9% NaCl) IV infusion which will be administered over 1 hour as a single 100 mL infusion, once a month over a 12 month treatment course. Both groups will receive standard of care treatment with ACEI (angiotensin-converting enzyme inhibitor) /ARB (angiotensin receptor blocker) therapy.

Next Version

In Sri Lanka, this study will be conducted at the following centers • Sri Jayawardenapura General Hospital • National Hospital of Sri Lanka • National Hospital - Kandy