RecruitingPhase 2NCT06797518

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

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


Sponsor

Novartis Pharmaceuticals

Enrollment

20 participants

Start Date

Feb 21, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Iptacopan for people with glomerulonephritis, iga and immunoglobulin a nephropathy. The study is currently recruiting participants at 18 locations. People eligible for this study include aged 18 Years to 99 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIptacopan

LNP023 oral capsule 200 mg b.i.d


Locations(18)

University of Alabama at Birmingham

Birmingham, Alabama, United States

UCLA Medical Center

Los Angeles, California, United States

Central Florida Kidney Specialists

Orlando, Florida, United States

Georgia Nephrology Research Inst

Lawrenceville, Georgia, United States

CaRe Research

Chubbuck, Idaho, United States

DaVita Clinical Research

Las Vegas, Nevada, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

OSU Wexner Medical Center

Columbus, Ohio, United States

Prolato Clinical Research Center

Houston, Texas, United States

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

CABA, Buenos Aires, Argentina

Novartis Investigative Site

Córdoba, Córdoba Province, Argentina

Novartis Investigative Site

Ashdod, Israel

Novartis Investigative Site

Hadera, Israel

Novartis Investigative Site

Haifa, Israel

Novartis Investigative Site

Nahariya, Israel

Novartis Investigative Site

Kuala Lumpur, Selangor, Malaysia

Novartis Investigative Site

Riyadh, Saudi Arabia

View Full Details on ClinicalTrials.gov

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NCT06797518


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