Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT06797518
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-01-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Impact of Iptacopan on Top of SOC on Biopsy Changes in Kidneys of Adult Patients With IgAN
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A Multicenter, Single Arm, Open Label Biopsy Study to Evaluate Structural and Functional Changes in Kidneys of Adult Patients With IgA Nephropathy Receiving Iptacopan on Top of Supportive Care
Status:
RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: