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Invited Paper Session

Novel Statistical Approaches for Endpoint Analysis in Modern Nephrology Clinical Trials

Thu, Aug 6, 8:30 AM - 10:20 AM Room CC-208 Thomas M. Menino Convention & Exhibition Center

Will EaganOrganizerEric J. DazaOrganizerMaria Montez-RathChairMaria Montez-RathOrganizer

ENAR co: WNARco: Biometrics Section Applied

5 Presentations

Acute Phase Nonlinearity in Clinical Trials of Chronic Kidney Disease

9:35 AM - 9:55 AM

Edward Vonesh (Vonesh Statistical Consulting, LLC)

chronic kidney disease estimated glomerular filtration rate nonlinearity cubic splines chronic slope

Leveraging Historical eGFR Data to Enhance Treatment Efficacy Assessment in Nephrology Trials

9:15 AM - 9:35 AM

Hui Sun (Novartis Pharmaceuticals)

nephrology eGFR Historical data integration linear mixed effect model Longitudinal Analysis

Longitudinal Matching with Mediation Analysis for Surrogate Endpoint Evaluation using Observational Data

8:55 AM - 9:15 AM

Jarcy Zee (University of Pennsylvania)

surrogate endpoints time-varying biomarkers mediation analysis longitudinal matching survival outcomes rare kidney disease

Proteinuria and eGFR as clinical trial endpoints in focal segmental glomerulosclerosis (PARASOL)

9:55 AM - 10:15 AM

Abigail Smith (Northwestern University)

Clinical trial outcomes Data harmonization Glomerular diseases

Structured Composite Endpoints for Chronic Kidney Disease Clinical Trials

8:35 AM - 8:55 AM

Tom Greene (University of Utah)

Clinical Trial Design Composite Outcomes Surrogate Endpoints Bayesian Analysis Chronic Kidney Disease

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