CureGN Study Rationale, Design, and Methods: Establishing a Large Prospective Observational Study of Glomerular Disease

Laura H Mariani; Andrew S Bomback; Pietro A Canetta; Michael F Flessner; Margaret Helmuth; Michelle A Hladunewich; Jonathan J Hogan; Krzysztof Kiryluk; Patrick H Nachman; Cynthia C Nast; Michelle N Rheault; Dana V Rizk; Howard Trachtman; Scott E Wenderfer; Corinna Bowers; Peg Hill-Callahan; Maddalena Marasa; Caroline J Poulton; Adelaide Revell; Suzanne Vento; Laura Barisoni; Dan Cattran; Vivette D’Agati; J. Charles Jennette; Jon B Klein; Louis-Philippe Laurin; Katherine Twombley; Ronald J Falk; Ali G Gharavi; Brenda W Gillespie; Debbie S Gipson; Larry A Greenbaum; Lawrence B Holzman; Matthias Kretzler; Bruce Robinson; William E Smoyer; Lisa M Guay-Woodford; Wooin Ahn; Gerald B Appel; Revekka Babayev; Ibrahim Batal; Eric Brown; Eric S Campenot; Pietro Canetta; Lucrezia Carlassara; Brenda Chan; Debanjana Chatterjee; Vivette D D’Agati; Elisa Delbarba; Samriti Dogra; Hilda Fernandez; Bartosz Foroncewicz; Gian Marco Ghiggeri; William H Hines; S Ali Husain; Namrata G Jain; Pascale Khairallah; Byum Hee Kil; Anushya Jeyabalan; Wai L Lau; Fangming Lin; Francesca Lugani; Glen Markowitz; Sumit Mohan; Xueru Mu; Krzysztof Mucha; Thomas L Nickolas; Stacy Piva; Jai Radhakrishnan; Maya K Rao; Renu Regunathan-Shenk; Simone Sanna-Cherchi; Dominick Santoriello; Shayan Shirazian; Michael B Stokes; Natalie Yu; Anthony M Valeri; Ronald Zviti; Amira Al-Uzri; Josephine Ambruzs; Isa Ashoor; Diego Aviles; Rossana Baracco; John Barcia; Sharon Bartosh; Craig Belsha; Michael C Braun; Yi Cai; Vladimir Chernitskiy; Aftab Chishti; Donna Claes; Kira Clark; Carl Cramer; Keefe Davis; Amy Dutcher; Elif Erkan; Daniel Feig; Michael Freundlich; Joseph Gaut; Rasheed Gbadegesin; Melisha Hanna; Guillermo Hidalgo; David Hooper; Tracy E Hunley; Amrish Jain; Mahmoud Kallash; Margo Kamel; Myda Khalid; Theresa Kump; Jerome C Lane; Helen Liapis; John Mahan; Nisha Mathews; Carla Nester; Cynthia Pan; Larry Patterson; Hiren Patel; Alice Raad; Cynthia Silva; Rajasree Sreedharan; Tarak Srivastava; Julia Steinke; Susan Sumner; Tetyana L Vasylyeva; Chia-shi Wang; Donald J Weaver; Craig S Wong; Hong Yin; Anand Achanti; Salem Almaani; Isabelle Ayoub; Milos Budisavljevic; Maggie D'Angelo; Vimal Derebail; Huma Fatima; Ronald Falk; Agnes Fogo; Keisha Gibson; Dorey Glenn; Susan Hogan; Koyal Jain; Bruce Julian; Jason Kidd; H. Davis Massey; Amy Mottl; Shannon Murphy; Tibor Nadasdy; Jan Novak; Samir Parikh; Caroline Poulton; Thomas Brian Powell; Bryce Reeve; Matthew Renfrow; Monica Reynolds; Dana Rizk; Brad Rovin; Virginie Royal; Manish Saha; Neil Sanghani; Sally Self; Sharon Adler; Nada Alachkar; Charles Alpers; Raed Bou Matar; Carmen Avila-Casado; Serena Bagnasco; Emily Brede; Elizabeth Brown; Daniel Cattran; Michael Choi; Gabriel Contreras; Katherine M Dell; Darren Dewalt; Michelle Denburg; Ram Dukkipati; Fernando C Fervenza; Alessia Fornoni; Crystal Gadegbeku; Patrick Gipson; Anny Gonzalez-Zea; Leah Hasely; Elizabeth Hendren; Sangeeta Hingorani; Michelle Hladunewich; Jonathan Hogan; Jean Hou; J. Ashley Jefferson; Kenar Jhaveri; Duncan B Johnstone; Frederick Kaskel; Amy Kogan; Jeffrey Kopp; Richard Lafayette; Kevin V Lemley; Laura Malaga-Dieguez; Kevin Meyers; Alicia Neu; Michelle Marie O'Shaughnessy; John F O’Toole; Andrea Oliverio; Matthew Palmer; Rulan Parekh; Renee Pitter; Heather Reich; Kimberly Reidy; Helbert Rondon; Kamalanathan K Sambandam; Matthew Sampson; John R Sedor; David T Selewski; Christine B Sethna; Jeffrey Schelling; John C Sperati; Agnes Swiatecka-Urban; Katherine R Tuttle; Meryl Waldman; Joseph Weisstuch; Roger Wiggins; Cheryl Winkler; Eric Young; Olga Zhdanova; Charlotte Beil; Richard Eikstadt; Brenda Gillespie; John Graff; Stephen Hewitt; Emily Herreshoff; Chrysta Lienczewski; Sarah Mansfield; Laura Mariani; Keith McCullough; Nicholas Moore; Bruce M Robinson; Melissa Sexton; Jonathan Troost; Matthew Wladkowski; Jarcy Zee; Dawn Zinsser

doi:10.1053/j.ajkd.2018.07.020

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CureGN Study Rationale, Design, and Methods: Establishing a Large Prospective Observational Study of Glomerular Disease

Journal article

Open access

Peer reviewed

CureGN Study Rationale, Design, and Methods: Establishing a Large Prospective Observational Study of Glomerular Disease

Laura H Mariani, Andrew S Bomback, Pietro A Canetta, Michael F Flessner, Margaret Helmuth, Michelle A Hladunewich, Jonathan J Hogan, Krzysztof Kiryluk, Patrick H Nachman, Cynthia C Nast, …

American journal of kidney diseases, Vol.73(2), pp.218-229

2019-02

DOI: https://doi.org/10.1053/j.ajkd.2018.07.020

PMCID: PMC6348011

PMID: 30420158

Abstract

patient-reported outcome (PRO)

kidney biopsy

IgA nephropathy (IgAN)

IgA vasculitis (IgAV)

study design

longitudinal cohort

pediatric

membranous nephropathy (MN)

glomerulonephropathy

minimal change disease (MCD)

focal segmental glomerulosclerosis (FSGS)

CureGN

Glomerular disease

estimated glomerular filtration rate (eGFR)

Henoch-Schönlein purpura

digital pathology repository

adult

Glomerular diseases, including minimal change disease, focal segmental glomerulosclerosis, membranous nephropathy, and immunoglobulin A (IgA) nephropathy, share clinical presentations, yet result from multiple biological mechanisms. Challenges to identifying underlying mechanisms, biomarkers, and new therapies include the rarity of each diagnosis and slow progression, often requiring decades to measure the effectiveness of interventions to prevent end-stage kidney disease (ESKD) or death. Multicenter prospective cohort study. Cure Glomerulonephropathy (CureGN) will enroll 2,400 children and adults with minimal change disease, focal segmental glomerulosclerosis, membranous nephropathy, or IgA nephropathy (including IgA vasculitis) and a first diagnostic kidney biopsy within 5 years. Patients with ESKD and those with secondary causes of glomerular disease are excluded. Clinical data, including medical history, medications, family history, and patient-reported outcomes, are obtained, along with a digital archive of kidney biopsy images and blood and urine specimens at study visits aligned with clinical care 1 to 4 times per year. Patients are followed up for changes in estimated glomerular filtration rate, disease activity, ESKD, and death and for nonrenal complications of disease and treatment, including infection, malignancy, cardiovascular, and thromboembolic events. The study design supports multiple longitudinal analyses leveraging the diverse data domains of CureGN and its ancillary program. At 2,400 patients and an average of 2 years’ initial follow-up, CureGN has 80% power to detect an HR of 1.4 to 1.9 for proteinuria remission and a mean difference of 2.1 to 3.0mL/min/1.73m2 in estimated glomerular filtration rate per year. Current follow-up can only detect large differences in ESKD and death outcomes. Study infrastructure will support a broad range of scientific approaches to identify mechanistically distinct subgroups, identify accurate biomarkers of disease activity and progression, delineate disease-specific treatment targets, and inform future therapeutic trials. CureGN is expected to be among the largest prospective studies of children and adults with glomerular disease, with a broad goal to lessen disease burden and improve outcomes.

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Collaboration types: Domestic collaboration; International collaboration
Citation topics: 1 Clinical & Life Sciences; 1.55 Urology & Nephrology - General; 1.55.820 IgA Nephropathy
Web Of Science research areas: Urology & Nephrology
ESI research areas: Clinical Medicine

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Title: CureGN Study Rationale, Design, and Methods: Establishing a Large Prospective Observational Study of Glomerular Disease
Creators: Laura H Mariani - Division of Nephrology, Department of Medicine, University of Michigan, Ann Arbor, MI
Andrew S Bomback - Division of Nephrology, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY
Pietro A Canetta - Division of Nephrology, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY
Michael F Flessner - National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Bethesda, MD
Margaret Helmuth - Arbor Research Collaborative for Health, Ann Arbor, MI
Michelle A Hladunewich - Division of Nephrology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada
Jonathan J Hogan - Renal-Electrolyte and Hypertension Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA
Krzysztof Kiryluk - Division of Nephrology, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY
Patrick H Nachman - Division of Renal Diseases and Hypertension, Department of Medicine, University of Minnesota, Minneapolis, MN
Cynthia C Nast - Department of Pathology, Cedars-Sinai Medical Center, Los Angeles, CA
Michelle N Rheault - Division of Nephrology, Department of Pediatrics, University of Minnesota Masonic Children’s Hospital, Minneapolis, MN
Dana V Rizk - Division of Nephrology, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL
Howard Trachtman - Division of Nephrology, Department of Pediatrics, New York University Langone Medical Center, New York, NY
Scott E Wenderfer - Renal Section, Department of Pediatrics, Baylor College of Medicine, Texas Children’s Hospital, Houston, TX
Corinna Bowers - Center for Clinical and Translational Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH
Peg Hill-Callahan - Arbor Research Collaborative for Health, Ann Arbor, MI
Maddalena Marasa - Division of Nephrology, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY
Caroline J Poulton - Division of Nephrology and Hypertension, Kidney Center, Department of Medicine, University of North Carolina, Chapel Hill, NC
Adelaide Revell - Center for Clinical and Translational Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH
Suzanne Vento - Division of Nephrology, Department of Pediatrics, New York University Langone Medical Center, New York, NY
Laura Barisoni - Department of Pathology, University of Miami, Miami, FL
Dan Cattran - Division of Nephrology, University Health Network, University of Toronto, Toronto, ON, Canada
Vivette D’Agati - Department of Pathology, Columbia University Medical Center, New York, NY
J. Charles Jennette - Department of Pathology and Laboratory Medicine, University of North Carolina, Chapel Hill, NC
Jon B Klein - Department of Medicine, The University of Louisville School of Medicine, and Robley Rex VA Medical Center, Louisville, KY
Louis-Philippe Laurin - Division of Nephrology, Maisonneuve-Rosemont Hospital, Montreal, QC, Canada
Katherine Twombley - Pediatric Nephrology, Medical University of South Carolina, Charleston, SC
Ronald J Falk - Division of Nephrology and Hypertension, Kidney Center, Department of Medicine, University of North Carolina, Chapel Hill, NC
Ali G Gharavi - Division of Nephrology, Department of Medicine, Columbia University College of Physicians and Surgeons, New York, NY
Brenda W Gillespie - Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor, MI
Debbie S Gipson - Division of Nephrology, Department of Pediatrics, University of Michigan, Ann Arbor, MI
Larry A Greenbaum - Emory University and Children’s Healthcare of Atlanta, Atlanta, GA
Lawrence B Holzman - Renal-Electrolyte and Hypertension Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA
Matthias Kretzler - Division of Nephrology, Department of Medicine, University of Michigan, Ann Arbor, MI
Bruce Robinson - Division of Nephrology, Department of Medicine, University of Michigan, Ann Arbor, MI
William E Smoyer - Center for Clinical and Translational Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH
Lisa M Guay-Woodford - Center for Translational Science, Children’s National Health System, Washington, DC
Wooin Ahn
Gerald B Appel
Revekka Babayev
Ibrahim Batal
Andrew S Bomback
Eric Brown
Eric S Campenot
Pietro Canetta
Lucrezia Carlassara
Brenda Chan
Debanjana Chatterjee
Vivette D D’Agati
Elisa Delbarba
Samriti Dogra
Hilda Fernandez
Bartosz Foroncewicz
Ali G Gharavi
Gian Marco Ghiggeri
William H Hines
S Ali Husain
Namrata G Jain
Pascale Khairallah
Byum Hee Kil
Krzysztof Kiryluk
Anushya Jeyabalan
Wai L Lau
Fangming Lin
Francesca Lugani
Maddalena Marasa
Glen Markowitz
Sumit Mohan
Xueru Mu
Krzysztof Mucha
Thomas L Nickolas
Stacy Piva
Jai Radhakrishnan
Maya K Rao
Renu Regunathan-Shenk
Simone Sanna-Cherchi
Dominick Santoriello
Shayan Shirazian
Michael B Stokes
Natalie Yu
Anthony M Valeri
Ronald Zviti
Larry A Greenbaum
William E Smoyer
Amira Al-Uzri
Josephine Ambruzs
Isa Ashoor
Diego Aviles
Rossana Baracco
John Barcia
Sharon Bartosh
Craig Belsha
Corinna Bowers
Michael C Braun
Yi Cai
Vladimir Chernitskiy
Aftab Chishti
Donna Claes
Kira Clark
Carl Cramer
Keefe Davis
Amy Dutcher
Elif Erkan
Daniel Feig
Michael Freundlich
Joseph Gaut
Rasheed Gbadegesin
Melisha Hanna
Guillermo Hidalgo
David Hooper
Tracy E Hunley
Amrish Jain
Mahmoud Kallash
Margo Kamel
Myda Khalid
Jon B Klein
Theresa Kump
Jerome C Lane
Helen Liapis
John Mahan
Nisha Mathews
Carla Nester
Cynthia Pan
Larry Patterson
Hiren Patel
Alice Raad
Adelaide Revell
Michelle N Rheault
Cynthia Silva
Rajasree Sreedharan
Tarak Srivastava
Julia Steinke
Susan Sumner
Katherine Twombley
Scott E Wenderfer
Tetyana L Vasylyeva
Chia-shi Wang
Donald J Weaver
Craig S Wong
Hong Yin
Anand Achanti
Salem Almaani
Isabelle Ayoub
Milos Budisavljevic
Maggie D'Angelo
Vimal Derebail
Huma Fatima
Ronald Falk
Agnes Fogo
Keisha Gibson
Dorey Glenn
Susan Hogan
Koyal Jain
J. Charles Jennette
Bruce Julian
Jason Kidd
Louis-Philippe Laurin
H. Davis Massey
Amy Mottl
Shannon Murphy
Tibor Nadasdy
Jan Novak
Samir Parikh
Caroline Poulton
Thomas Brian Powell
Bryce Reeve
Matthew Renfrow
Monica Reynolds
Dana Rizk
Brad Rovin
Virginie Royal
Manish Saha
Neil Sanghani
Sally Self
Sharon Adler
Nada Alachkar
Charles Alpers
Raed Bou Matar
Carmen Avila-Casado
Serena Bagnasco
Emily Brede
Elizabeth Brown
Daniel Cattran
Michael Choi
Gabriel Contreras
Katherine M Dell
Darren Dewalt
Michelle Denburg
Ram Dukkipati
Fernando C Fervenza
Alessia Fornoni
Crystal Gadegbeku
Patrick Gipson
Anny Gonzalez-Zea
Leah Hasely
Elizabeth Hendren
Sangeeta Hingorani
Michelle Hladunewich
Jonathan Hogan
Lawrence B Holzman
Jean Hou
J. Ashley Jefferson
Kenar Jhaveri
Duncan B Johnstone
Frederick Kaskel
Amy Kogan
Jeffrey Kopp
Richard Lafayette
Kevin V Lemley
Laura Malaga-Dieguez
Kevin Meyers
Alicia Neu
Michelle Marie O'Shaughnessy
John F O’Toole
Andrea Oliverio
Matthew Palmer
Rulan Parekh
Renee Pitter
Heather Reich
Kimberly Reidy
Helbert Rondon
Kamalanathan K Sambandam
Matthew Sampson
John R Sedor
David T Selewski
Christine B Sethna
Jeffrey Schelling
John C Sperati
Agnes Swiatecka-Urban
Howard Trachtman
Katherine R Tuttle
Meryl Waldman
Joseph Weisstuch
Roger Wiggins
Cheryl Winkler
Suzanne Vento
Eric Young
Olga Zhdanova
Laura Barisoni
Charlotte Beil
Richard Eikstadt
Brenda Gillespie
Debbie S Gipson
John Graff
Stephen Hewitt
Peg Hill-Callahan
Margaret Helmuth
Emily Herreshoff
Matthias Kretzler
Chrysta Lienczewski
Sarah Mansfield
Laura Mariani
Keith McCullough
Nicholas Moore
Cynthia C Nast
Bruce M Robinson
Melissa Sexton
Jonathan Troost
Matthew Wladkowski
Jarcy Zee
Dawn Zinsser
Lisa M Guay-Woodford
Publication Details: American journal of kidney diseases, Vol.73(2), pp.218-229
Publisher: Elsevier Inc
Grant note: UM1DK100845; UM1DK100846; UM1DK100876; UM1DK100866; UM1DK100867 / NIDDK (https://doi.org/10.13039/100000062)
Academic Unit: Miller School of Medicine; Peggy and Harold Katz Family Drug Discovery Center; UMMG Department of Pathology; UMMG Dept of Medicine - Nephrology & Hypertension Div; UMMG Department of Pediatrics
Language: English
Resource Type: Journal article
PMID: 30420158
PMCID: PMC6348011
Record Identifier: 991031578452402976