CureGN Study Rationale, Design, and Methods: Establishing a Large Prospective Observational Study of Glomerular Disease.
Academic Medical Centers
Adolescent
Adult
Age Factors
Biopsy, Needle
Child
Diagnosis, Differential
Disease Progression
Female
Glomerulonephritis
/ mortality
Glomerulonephritis, IGA
/ mortality
Glomerulonephritis, Membranous
/ mortality
Glomerulosclerosis, Focal Segmental
/ mortality
Humans
Immunohistochemistry
Kidney Failure, Chronic
/ prevention & control
Linear Models
Male
Middle Aged
Multivariate Analysis
Nephrosis, Lipoid
/ mortality
Prognosis
Prospective Studies
Risk Assessment
Severity of Illness Index
Sex Factors
Survival Analysis
Young Adult
CureGN
Glomerular disease
Henoch-Schönlein purpura
IgA nephropathy (IgAN)
IgA vasculitis (IgAV)
adult
digital pathology repository
estimated glomerular filtration rate (eGFR)
focal segmental glomerulosclerosis (FSGS)
glomerulonephropathy
kidney biopsy
longitudinal cohort
membranous nephropathy (MN)
minimal change disease (MCD)
patient-reported outcome (PRO)
pediatric
study design
Journal
American journal of kidney diseases : the official journal of the National Kidney Foundation
ISSN: 1523-6838
Titre abrégé: Am J Kidney Dis
Pays: United States
ID NLM: 8110075
Informations de publication
Date de publication:
02 2019
02 2019
Historique:
received:
08
03
2018
accepted:
31
07
2018
pubmed:
14
11
2018
medline:
13
11
2019
entrez:
14
11
2018
Statut:
ppublish
Résumé
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/1.73m 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.
Identifiants
pubmed: 30420158
pii: S0272-6386(18)30936-3
doi: 10.1053/j.ajkd.2018.07.020
pmc: PMC6348011
mid: NIHMS1512170
pii:
doi:
Types de publication
Comparative Study
Journal Article
Multicenter Study
Observational Study
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
218-229Subventions
Organisme : NIDDK NIH HHS
ID : U24 DK100845
Pays : United States
Organisme : NIDDK NIH HHS
ID : U01 DK100866
Pays : United States
Organisme : NIDDK NIH HHS
ID : UM1 DK100846
Pays : United States
Organisme : NIDDK NIH HHS
ID : U01 DK100876
Pays : United States
Organisme : NIDDK NIH HHS
ID : UM1 DK100845
Pays : United States
Organisme : NIDDK NIH HHS
ID : UM1 DK100867
Pays : United States
Organisme : NIDDK NIH HHS
ID : K08 DK115891
Pays : United States
Organisme : NIDDK NIH HHS
ID : UM1 DK100866
Pays : United States
Organisme : NIDDK NIH HHS
ID : U24 DK114886
Pays : United States
Organisme : NIDDK NIH HHS
ID : U01 DK100846
Pays : United States
Organisme : NIDDK NIH HHS
ID : UM1 DK100876
Pays : United States
Investigateurs
Wooin Ahn
(W)
Gerald B Appel
(GB)
Revekka Babayev
(R)
Ibrahim Batal
(I)
Andrew S Bomback
(AS)
Eric Brown
(E)
Eric S Campenot
(ES)
Pietro Canetta
(P)
Lucrezia Carlassara
(L)
Brenda Chan
(B)
Debanjana Chatterjee
(D)
Vivette D D'Agati
(VD)
Elisa Delbarba
(E)
Samriti Dogra
(S)
Hilda Fernandez
(H)
Bartosz Foroncewicz
(B)
Ali G Gharavi
(AG)
Gian Marco Ghiggeri
(GM)
William H Hines
(WH)
S Ali Husain
(S)
Namrata G Jain
(NG)
Pascale Khairallah
(P)
Byum Hee Kil
(BH)
Krzysztof Kiryluk
(K)
Anushya Jeyabalan
(A)
Wai L Lau
(WL)
Fangming Lin
(F)
Francesca Lugani
(F)
Maddalena Marasa
(M)
Glen Markowitz
(G)
Sumit Mohan
(S)
Xueru Mu
(X)
Krzysztof Mucha
(K)
Thomas L Nickolas
(TL)
Stacy Piva
(S)
Jai Radhakrishnan
(J)
Maya K Rao
(MK)
Renu Regunathan-Shenk
(R)
Simone Sanna-Cherchi
(S)
Dominick Santoriello
(D)
Shayan Shirazian
(S)
Michael B Stokes
(MB)
Natalie Yu
(N)
Anthony M Valeri
(AM)
Ronald Zviti
(R)
Larry A Greenbaum
(LA)
William E Smoyer
(WE)
Amira Al-Uzri
(A)
Josephine Ambruzs
(J)
Isa Ashoor
(I)
Diego Aviles
(D)
Rossana Baracco
(R)
John Barcia
(J)
Sharon Bartosh
(S)
Craig Belsha
(C)
Corinna Bowers
(C)
Michael C Braun
(MC)
Yi Cai
(Y)
Vladimir Chernitskiy
(V)
Aftab Chishti
(A)
Donna Claes
(D)
Kira Clark
(K)
Carl Cramer
(C)
Keefe Davis
(K)
Amy Dutcher
(A)
Elif Erkan
(E)
Daniel Feig
(D)
Michael Freundlich
(M)
Joseph Gaut
(J)
Rasheed Gbadegesin
(R)
Melisha Hanna
(M)
Guillermo Hidalgo
(G)
David Hooper
(D)
Tracy E Hunley
(TE)
Amrish Jain
(A)
Mahmoud Kallash
(M)
Margo Kamel
(M)
Myda Khalid
(M)
Jon B Klein
(JB)
Theresa Kump
(T)
Jerome C Lane
(JC)
Helen Liapis
(H)
John Mahan
(J)
Nisha Mathews
(N)
Carla Nester
(C)
Cynthia Pan
(C)
Larry Patterson
(L)
Hiren Patel
(H)
Alice Raad
(A)
Adelaide Revell
(A)
Michelle N Rheault
(MN)
Cynthia Silva
(C)
Rajasree Sreedharan
(R)
Tarak Srivastava
(T)
Julia Steinke
(J)
Susan Sumner
(S)
Katherine Twombley
(K)
Scott E Wenderfer
(SE)
Tetyana L Vasylyeva
(TL)
Chia-Shi Wang
(CS)
Donald J Weaver
(DJ)
Craig S Wong
(CS)
Hong Yin
(H)
Anand Achanti
(A)
Salem Almaani
(S)
Isabelle Ayoub
(I)
Milos Budisavljevic
(M)
Maggie D'Angelo
(M)
Vimal Derebail
(V)
Huma Fatima
(H)
Ronald Falk
(R)
Agnes Fogo
(A)
Keisha Gibson
(K)
Dorey Glenn
(D)
Susan Hogan
(S)
Koyal Jain
(K)
J Charles Jennette
(JC)
Bruce Julian
(B)
Jason Kidd
(J)
Louis-Philippe Laurin
(LP)
H Davis Massey
(HD)
Amy Mottl
(A)
Shannon Murphy
(S)
Tibor Nadasdy
(T)
Jan Novak
(J)
Samir Parikh
(S)
Caroline Poulton
(C)
Thomas Brian Powell
(TB)
Bryce Reeve
(B)
Matthew Renfrow
(M)
Monica Reynolds
(M)
Dana Rizk
(D)
Brad Rovin
(B)
Virginie Royal
(V)
Manish Saha
(M)
Neil Sanghani
(N)
Sally Self
(S)
Sharon Adler
(S)
Nada Alachkar
(N)
Charles Alpers
(C)
Raed Bou Matar
(RB)
Carmen Avila-Casado
(C)
Serena Bagnasco
(S)
Emily Brede
(E)
Elizabeth Brown
(E)
Daniel Cattran
(D)
Michael Choi
(M)
Gabriel Contreras
(G)
Katherine M Dell
(KM)
Darren Dewalt
(D)
Michelle Denburg
(M)
Ram Dukkipati
(R)
Fernando C Fervenza
(FC)
Alessia Fornoni
(A)
Crystal Gadegbeku
(C)
Patrick Gipson
(P)
Anny Gonzalez-Zea
(A)
Leah Hasely
(L)
Elizabeth Hendren
(E)
Sangeeta Hingorani
(S)
Michelle Hladunewich
(M)
Jonathan Hogan
(J)
Lawrence B Holzman
(LB)
Jean Hou
(J)
J Ashley Jefferson
(JA)
Kenar Jhaveri
(K)
Duncan B Johnstone
(DB)
Frederick Kaskel
(F)
Amy Kogan
(A)
Jeffrey Kopp
(J)
Richard Lafayette
(R)
Kevin V Lemley
(KV)
Laura Malaga-Dieguez
(L)
Kevin Meyers
(K)
Alicia Neu
(A)
Michelle Marie O'Shaughnessy
(MM)
John F O'Toole
(JF)
Andrea Oliverio
(A)
Matthew Palmer
(M)
Rulan Parekh
(R)
Renee Pitter
(R)
Heather Reich
(H)
Kimberly Reidy
(K)
Helbert Rondon
(H)
Kamalanathan K Sambandam
(KK)
Matthew Sampson
(M)
John R Sedor
(JR)
David T Selewski
(DT)
Christine B Sethna
(CB)
Jeffrey Schelling
(J)
John C Sperati
(JC)
Agnes Swiatecka-Urban
(A)
Howard Trachtman
(H)
Katherine R Tuttle
(KR)
Meryl Waldman
(M)
Joseph Weisstuch
(J)
Roger Wiggins
(R)
David Williams
(D)
Cheryl Winkler
(C)
Suzanne Vento
(S)
Eric Young
(E)
Olga Zhdanova
(O)
Laura Barisoni
(L)
Charlotte Beil
(C)
Richard Eikstadt
(R)
Brenda Gillespie
(B)
Debbie S Gipson
(DS)
John Graff
(J)
Stephen Hewitt
(S)
Peg Hill-Callahan
(P)
Margaret Helmuth
(M)
Emily Herreshoff
(E)
Matthias Kretzler
(M)
Chrysta Lienczewski
(C)
Sarah Mansfield
(S)
Laura Mariani
(L)
Keith McCullough
(K)
Nicholas Moore
(N)
Cynthia C Nast
(CC)
Bruce M Robinson
(BM)
Melissa Sexton
(M)
Jonathan Troost
(J)
Matthew Wladkowski
(M)
Jarcy Zee
(J)
Dawn Zinsser
(D)
Lisa M Guay-Woodford
(LM)
Informations de copyright
Copyright © 2018 National Kidney Foundation, Inc. All rights reserved.
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