Study of Iptacopan Added to Standard Care in Adults with IgA Nephropathy to Assess Kidney Biopsy Changes and Treatment Effects

What this Trial Is About

Researchers are evaluating the impact of iptacopan treatment on adult patients with Immunoglobulin A Nephropathy IgAN. This study focuses on changes in kidney tissue and immune system markers related to the disease and aims to better understand the treatments effects on both systemic and kidney-specific aspects of IgAN. The trial is designed as a Phase 2, open-label, single-group study led by Novartis Pharmaceuticals. Participants will undergo a screening period followed by a baseline kidney biopsy. Eligible individuals receive iptacopan 200 mg twice daily orally for a 9-month treatment period without dose adjustments. At the end of treatment, a follow-up kidney biopsy is conducted to assess changes. Throughout the study, participants remain on their maximum tolerated or locally approved doses of ACE inhibitors or angiotensin receptor blockers. During the trial, participants will have kidney biopsies at baseline and at 9 months to evaluate complement activation and other markers of kidney function and disease progression. Researchers will monitor clinical and molecular biomarkers, including mesangial C3c deposition and CD68 cells. The study measures the proportion of participants achieving significant reductions in complement deposits, alongside changes in immunoglobulin staining. The total participation time extends through the 9-month treatment and follow-up biopsy.

Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN