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

• Main Authors: Susan M. Samuel, Allison Dart, Guido Filler, Martin Bitzan, Maury Pinsk, Cherry Mammen, Alberto Nettel-Aguirre, Maneka A. Perinpanayagam, Tomoko Takano, Rahul Chanchlani, Michael Zappitelli, other members of the Canadian Childhood Nephrotic Syndrome Project Team
• Format: Article
• Language: English
• Published: BMC 2019-05-01
• Series: BMC Nephrology
• Subjects: Nephrotic syndrome; Children; Longitudinal study; Glucocorticoids; Practice variation
• Online Access: http://link.springer.com/article/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.