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
Novartis Pharmaceuticals
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.
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).
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Signed informed consent must be obtained prior to participation in the study; participants should be able to communicate well with the investigator, understand and comply with the requirements of the study. 2. Male and female participants ≥18 years of age with biopsy-confirmed IgA nephropathy and an eGFR ≥ 30 mL/min/1.73m2. eGFR will be calculated using the CKD-EPI 2009 formula. 3. Proteinuria as assessed at screening by UPCR ≥ 0.8g/g or 1g/d sampled from FMV. 4. Biopsy at baseline should confirm IgAN with \< 50% tubulointerstitial fibrosis. 5. Participants must be on A…
Interventions
- DrugIptacopan
LNP023 oral capsule 200 mg b.i.d
Locations (18)
- University of Alabama at BirminghamBirmingham, Alabama
- UCLA Medical CenterLos Angeles, California
- Central Florida Kidney SpecialistsOrlando, Florida
- Georgia Nephrology Research InstLawrenceville, Georgia
- CaRe ResearchChubbuck, Idaho
- DaVita Clinical ResearchLas Vegas, Nevada