The Canadian childhood nephrotic syndrome (CHILDNEPH) study: report on mid-study feasibility, recruitment and main measures

BMC Nephrol. 2019 May 14;20(1):159. doi: 10.1186/s12882-019-1320-3.

Abstract

Background: To assess reasons for continuing practice variation in the management of childhood nephrotic syndrome despite expert reviews and guidelines, we are conducting a longitudinal cohort study in children with glucocorticoid sensitive nephrotic syndrome. Objectives of this mid-study report are to describe patient and physician recruitment characteristics, glucocorticoid prescriptions, use of second line agents, biopsy practices, and adherence to study protocol.

Methods: Children with new onset nephrotic syndrome and providers are being recruited from all 12 pediatric nephrology centres across Canada with > 2½ years follow-up. Data collection points of observation are over a minimum 36 months. Details of prescribed glucocorticoids and of all second line agents used during treatment are being collected. All relapses are being recorded with time to urinary remission of proteinuria.

Results: To date, 243 patients (57.1% male) from 12 centres were included. Median number of patients per centre was 29 (range 2-45), and median age of cohort was 7.3 (IQR 4.2) at enrollment. Forty-eight physicians were recruited, median 5 (range 2-8) per site. Median number of relapses per patient year of follow-up was 2.1 (IQR 4). Cumulative dose variability of glucocorticoids prescribed per episode of proteinuria and length of treatment was observed between participating centres.

Conclusion: The Canadian pediatric nephrology community established a longitudinal childhood nephrotic syndrome cohort study that confirms ongoing practice variability. The study will help to evaluate its impact on patient outcomes, and facilitate clinical trial implementation in nephrotic syndrome.

Keywords: Children; Glucocorticoids; Longitudinal study; Nephrotic syndrome; Practice variation.

Publication types

  • Observational Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Canada / epidemiology
  • Child
  • Child, Preschool
  • Cohort Studies
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Glucocorticoids / therapeutic use*
  • Humans
  • Infant
  • Longitudinal Studies
  • Male
  • Nephrotic Syndrome / drug therapy*
  • Nephrotic Syndrome / epidemiology*
  • Nephrotic Syndrome / urine
  • Patient Selection*
  • Research Report*

Substances

  • Glucocorticoids

Grants and funding