drugset / Trial / NCT06797518

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

NCT06797518

Phase 2 Recruiting 20 enrolled Novartis Pharmaceuticals
NaSingle-groupOpen-labelTreatment

Summary

A study to investigate the impact of iptacopan treatment on the underlying immunopathology in patients with IgAN by assessing changes in key clinical and molecular markers from baseline to 9 months. The study aims to provide insights into the treatment's systemic and kidney-specific aspects by quantifying the change in mesangial C3c containing fragments deposition, as an indicator of complement activation, and evaluating a variety of biomarkers related to kidney function, damage, and disease progression, including but not limited to Oxford MEST-C score.

Timeline

Start
2025-02-21
Primary completion
2027-11-27
Completion
2027-11-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Iptacopan Small molecule 200 mg Oral