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

Publication ,  Journal Article
Mariani, LH; Bomback, AS; Canetta, PA; Flessner, MF; Helmuth, M; Hladunewich, MA; Hogan, JJ; Kiryluk, K; Nachman, PH; Nast, CC; Rheault, MN ...
Published in: Am J Kidney Dis
February 2019

RATIONALE & OBJECTIVES: 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. STUDY DESIGN: Multicenter prospective cohort study. SETTING & PARTICIPANTS: 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. EXPOSURES: 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. OUTCOMES: 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. ANALYTICAL APPROACH: 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. LIMITATIONS: Current follow-up can only detect large differences in ESKD and death outcomes. CONCLUSIONS: 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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Published In

Am J Kidney Dis

DOI

EISSN

1523-6838

Publication Date

February 2019

Volume

73

Issue

2

Start / End Page

218 / 229

Location

United States

Related Subject Headings

  • Young Adult
  • Urology & Nephrology
  • Survival Analysis
  • Sex Factors
  • Severity of Illness Index
  • Risk Assessment
  • Prospective Studies
  • Prognosis
  • Nephrosis, Lipoid
  • Multivariate Analysis
 

Citation

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Mariani, L. H., Bomback, A. S., Canetta, P. A., Flessner, M. F., Helmuth, M., Hladunewich, M. A., … CureGN Consortium, . (2019). CureGN Study Rationale, Design, and Methods: Establishing a Large Prospective Observational Study of Glomerular Disease. Am J Kidney Dis, 73(2), 218–229. https://doi.org/10.1053/j.ajkd.2018.07.020
Mariani, Laura H., Andrew S. Bomback, Pietro A. Canetta, Michael F. Flessner, Margaret Helmuth, Michelle A. Hladunewich, Jonathan J. Hogan, et al. “CureGN Study Rationale, Design, and Methods: Establishing a Large Prospective Observational Study of Glomerular Disease.Am J Kidney Dis 73, no. 2 (February 2019): 218–29. https://doi.org/10.1053/j.ajkd.2018.07.020.
Mariani LH, Bomback AS, Canetta PA, Flessner MF, Helmuth M, Hladunewich MA, et al. CureGN Study Rationale, Design, and Methods: Establishing a Large Prospective Observational Study of Glomerular Disease. Am J Kidney Dis. 2019 Feb;73(2):218–29.
Mariani, Laura H., et al. “CureGN Study Rationale, Design, and Methods: Establishing a Large Prospective Observational Study of Glomerular Disease.Am J Kidney Dis, vol. 73, no. 2, Feb. 2019, pp. 218–29. Pubmed, doi:10.1053/j.ajkd.2018.07.020.
Mariani LH, Bomback AS, Canetta PA, Flessner MF, Helmuth M, Hladunewich MA, Hogan JJ, Kiryluk K, Nachman PH, Nast CC, Rheault MN, Rizk DV, Trachtman H, Wenderfer SE, Bowers C, Hill-Callahan P, Marasa M, Poulton CJ, Revell A, Vento S, Barisoni L, Cattran D, D’Agati V, Jennette JC, Klein JB, Laurin L-P, Twombley K, Falk RJ, Gharavi AG, Gillespie BW, Gipson DS, Greenbaum LA, Holzman LB, Kretzler M, Robinson B, Smoyer WE, Guay-Woodford LM, CureGN Consortium. CureGN Study Rationale, Design, and Methods: Establishing a Large Prospective Observational Study of Glomerular Disease. Am J Kidney Dis. 2019 Feb;73(2):218–229.
Journal cover image

Published In

Am J Kidney Dis

DOI

EISSN

1523-6838

Publication Date

February 2019

Volume

73

Issue

2

Start / End Page

218 / 229

Location

United States

Related Subject Headings

  • Young Adult
  • Urology & Nephrology
  • Survival Analysis
  • Sex Factors
  • Severity of Illness Index
  • Risk Assessment
  • Prospective Studies
  • Prognosis
  • Nephrosis, Lipoid
  • Multivariate Analysis