Skip to content
Abstract dark blue ink painting

PARASOL

PROTEINURIA AND GFR AS CLINICAL TRIAL ENDPOINTS IN FOCAL SEGMENTAL GLOMERULOSCLEROSIS

ABOUT THE PROJECT

BACKGROUND

FSGS is a rare kidney disease that affects patients of all ages and has a high risk of progression to kidney failure. There are no FDA-approved therapies for this disease. Thus, there is an urgent need to conduct randomized clinical trials and to develop safe and effective therapies for FSGS. While the FDA currently accepts a complete remission or near normalization of proteinuria as a surrogate endpoint and basis for traditional approval of new treatments for FSGS, further work is needed to support the use of lesser changes in proteinuria as a basis for accelerated or traditional approval.

The PARASOL project builds upon and continues the important foundational work in this area conducted since 2019 by the Kidney Health Initiative (KHI). 

 

OBJECTIVE

PARASOL is a collaborative international effort that aims to define the quantitative relationships between short-term changes in biomarkers (proteinuria and GFR) and long-term outcomes in order to support the use of alternative proteinuria-based endpoints as a basis for accelerated and traditional approval.

The PARASOL group will achieve this in 2024 by conducting a large-scale analysis of existing data from patients of all ages with FSGS who are participants in observational cohort studies, regional or national registries, or real-world data sets. The project is sponsored by NephCure, the International Society of Glomerular Disease, the Kidney Health Initiative, and the National Kidney Foundation. The data analysis is led by a team from the Michigan Kidney Translational Medicine Center at the University of Michigan.

LEARN MORE: WEBINARS FOR INDUSTRY STAKEHOLDERS

Join us on a live webinar to learn more about PARASOL and ask questions of the organizing committee and project team.

The same information will be covered on both days; please choose the time that is most convenient for you. Can't join a webinar? Contact the team for more information.

NEWS

ORGANIZING COMMITTEE

  • Matthias Kretzler, MD, University of Michigan (Co-Chair)
  • Laura Mariani, MD, MSCE, FASN, University of Michigan (Co-Chair)
  • Laurel Damashek, MA, International Society of Glomerular Disease
  • Lauren Eva, NephCure
  • Barbara Gillespie, MD, Fortrea; Adjunct Professor, UNC
  • Tobias B. Huber, MD, International Society of Glomerular Disease and University Medical Center Hamburg-Eppendorf
  • Alex Mercer, PhD, JAMCO Pharma Consulting
  • Glory Onwuka, MS, International Society of Glomerular Disease
  • Abigail Smith, PhD, Northwestern University
  • Josh Tarnoff, NephCure
  • Aliza Thompson, MD, MS, FDA
  • Howard Trachtman, MD, University of Michigan
  • Hailey Desmond, MS, University of Michigan
  • Melissa West, American Society of Nephrology (Kidney Health Initiative)
  • Kerry Willis, PhD, National Kidney Foundation
HOW TO HELP

CONTACT THE PROJECT TEAM

Please contact the PARASOL team if you have any questions about the project, are interested in contributing data, or would like to participate in another way.

Laura Mariani, MD, MSCE
Associate Professor of Medicine, University of Michigan
lmariani@med.umich.edu

Laurel Damashek
Executive Director, International Society of Glomerular Disease
ldamashek@is-gd.org

 

IMG_8541
IMG_9739
IMG_9751
IMG_9748

SPONSORS