Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT06797518
Brief 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.
Detailed Description:
The study comprises of a screening period followed by a baseline visit, at which a baseline kidney biopsy will be performed. Eligible participants included in the study will receive iptacopan 200 mg b.i.d for a 9-month treatment period. Dose adjustment of iptacopan is not allowed during the treatment period. At Month 9, upon completion of the treatment period, a follow up biopsy is performed for all participants at the time of end of study (EOS).
Study:
NCT06797518
Study Brief:
Protocol Section:
NCT06797518