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Purpose​

The purpose of Prepare-NS is to develop and validate publicly available clinical outcome assessments (COAs) of fluid overload (FO) fit for drug development for a range of nephrotic syndrome (NS) inducing rare chronic kidney disorders.

Purpose
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Eloise Salmon, MD

Clinical Assistant Professor, Pediatric Nephrology, University of Michigan. Dr. Salmon treats patients with a range of kidney care needs, including dialysis and transplant. She completed her residency and fellowship training at the Children’s Hospital of Philadelphia. In this project, Dr. Salmon provides leadership of the stakeholder engagement activities, serves as the liaison with the NIH-sponsored consortia NEPTUNE and CureGN, and leads the implementation of multi-site study procedures leveraging the NEPTUNE and CureGN infrastructure during the UH3 phase. She is co-PI with Devin Peipert.

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John ("Devin") Peipert, PhD

125th Anniversary Chair and Professor of Health Outcomes Measurement, Centre for Patient Reported Outcomes Research, University of Birmingham. Dr. Peipert is a patient-reported outcomes (PRO) researcher and psychometrician who works on the development and validation of PRO Clinical Outcome Assessments (COAs) that are essential to understanding patients’ functionality, symptoms, and well-being using advanced psychometric methods. In this study, he leads the quantitative study design and execution, psychometric analyses, and quantitative data interpretation in both the UG3 and UH3 phases. He is co-PI with Dr. Salmon.

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Noelle Carlozzi, PhD, MS

Professor, Physical Medicine and Rehabilitation, University of Michigan. The director of the Center for Clinical Outcomes Development and Application in the Department of Physical Medicine and Rehabilitation and the Center for Health, Policy and Innovation (IHPI). Dr. Carlozzi's research focuses on outcomes measurement development and the examination of psychometric properties of standardized tests.

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Jin-Shei Lai, PhD

Professor, Departments of Medical Social Sciences and Pediatrics, Northwestern University Feinberg School of Medicine. Dr. Lai is a patient-centered-outcomes researcher and a registered occupational therapist with extensive experience in measurement, psychometrics, instrument development, and symptom management in people with chronic conditions. Dr. Lai uses mixed qualitative and quantitative methods to conduct clinically relevant research.

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Trivellore Raghunathan, PhD

Professor, Biostatistics, University of Michigan. Dr. Raghunathan is the Director at the esteemed Institute for Social Research. His research focuses on analysis of incomplete data, multiple imputation, Bayesian methods, design and analysis of sample surveys, and much more.

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Ashley Rahimi, MS

Senior Research Area Specialist, Pediatric Nephrology Research, University of Michigan. Ms. Rahimi serves as a project manager for the Prepare-NS study responsible for project administration, coordination, and reporting. She is a project liaison to interested sponsors, stakeholder engagement groups, and regulatory bodies. 

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Courtney Hurt, MSW

Senior Project Manager, Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine. Ms. Hurt manages PRO measure development and implementation projects and  provides project management support for the Prepare-NS study.

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Becky Scherr, MA

Senior Project Manager, Pediatric Nephrology Research, University of Michigan. Ms. Scherr serves as a project manager on the Prepare-NS study, focusing on human subject research compliance and other supporting tasks.

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Somayeh (Minoo) Hashemi, MPH

Associate Research Area Specialist, Pediatric Nephrology Research, University of Michigan. Ms. Hashemi supports data collection for the Prepare-NS study.

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Yan Zhai, MS

Statistician, Pediatric Nephrology Research, University of Michigan. Ms. Zhai supports data analysis, statistical programming, statistical modeling, and data visualization for the Prepare-NS study.

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Richard Eikstadt, BSEE

Senior Data Architect, Pediatric Nephrology Research, University of Michigan. Mr. Eikstadt provides programming, data management, and technical expertise to the Prepare-NS study.

Core Team

Core Team

Stakeholders & Consultants

The External Technical Advisory Committee (ETAC) 

The External Technical Advisory Committee (ETAC) represents the foremost experts on Core Outcomes Assessment (COA) development and evaluation for regulatory use.  They play an active role in guiding scientific aspects of the project, guiding logistical and programmatic elements, and participate in Planning, Evaluation/Validation, and Dissemination project phases.

  • Robyn Bent, MS, RN -- FDA

  • Melanie Calvert, PhD -- University of Birmingham

  • David Cella, PhD -- Northwestern University

  • Sonya Eremenco, MA -- Critical Path Institute; PRO Consortium

  • Allison Jaure, PhD -- Sydney Medical School; PI, Standardised Outcomes in Nephrology (SONG)

  • Kathleen Wyrwich, PhD -- Bristol Myers Squibb

Committees

The Clinical Expert Panel (CEP)

​The Clinical Expert Panel (CEP) participates in scheduled meetings and provides clinician perspectives to inform the Prepare-NS study.

  • David Selewski, MD, MS (co-chair) -- Medical University of South Carolina

  • Richard Lafayette, MD (co-chair) -- Stanford University School of Medicine

  • Keisha Gibson, MD, MPH -- University of North Carolina School of Medicine

  • Kristen Hood, EdD, MSN, RN -- Travere Therapeutics

  • Matthias Kretzler, MD -- University of Michigan Medical School

  • Laura Mariani, MD, MSCE -- University of Michigan Medical School

  • Susan Massengill, MD -- Levine Children's Hospital, Carolinas Medical Center

  • Jun Oh, MD -- University Medical Center, Hamburg

  • Louse Oni, PhD -- University of Liverpool, England

  • Brad Rovin, MD -- The Ohio State University

  • Howard Trachtman, MD -- New York University Langone Medical Center

  • Shikha Wadhwani, MD -- University of Texas Medical Branch

The Stakeholder Engagement Group (SEG) 

​The Stakeholder Engagement Group (SEG) is composed of patients and caregivers, as well as representatives with drug development, patient-centered science, patient advocacy and engagement, payer, and clinical expertise. The group participates in meetings and contributes perspectives essential to developing meaningful outcome measures.

  • Patrick Nachman, MD (co-chair) -- University of Minnesota

  • Brittney Parris (co-chair) -- NephCure

  • Anupam Chugh -- care partner

  • Theodore Danoff, MD, PhD -- Pathalys Pharma

  • David Feldman, PhD -- National Kidney Foundation

  • Folke Folkvaljon, MSc -- AstraZeneca

  • Jay Garg, MD -- Genentech

  • Houston Gilbert, PhD -- Hi-Bio

  • Barbara Gillespie, MMS, MD -- Fortera

  • Christine Gwinn -- patient

  • John Letterman -- patient

  • Meg Modes -- care partner

  • Dr. Nima Soleymanlou -- Boehringer Ingelheim

  • Melissa West, MA -- American Society of Nephrology

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