Sally Mountcastle, Keele Wurst, Alice Rouleau, Neil R Brett, Jennifer McKenzie, Justyna Amelio, Kathy Fraeman, Jake Hunnicutt, Susanna Cuadripani, David Webb, Amrit Kaur, Rukshana Shroff, Eleonora Staines Urias, Anna Richards, Thomas F Hiemstra
This study demonstrates feasibility of retrospectively extracting clinical characteristics, treatment history, and AEs from medical charts of pediatric patients with anemia of CKD.
BACKGROUND: Anemia is a common complication of chronic kidney disease (CKD). We evaluated the feasibility of collecting comprehensive data from medical charts for longitudinal assessment of anemia among pediatric patients receiving erythropoiesis-stimulating agents (ESAs) for anemia of CKD in the United Kingdom (UK) and United States (US).
METHODS: This retrospective chart review study used an electronic case report form to collect data from medical records of pediatric patients treated with an ESA (as either an incident or a prevalent patient) from January 1, 2017-December 31, 2018. Consecutive chart reviews were conducted from November 1-December 20, 2021. Data collected included clinical characteristics, disease, and treatment management.
RESULTS: Of 50 patients enrolled, 36 (72.0%) and 14 (28.0%) were from the UK and US, respectively; median (interquartile range) age was 9.0 (4.0-11.0) years, 22 (44.0%) were female and 28 (56.0%) were male. Median follow-up was 52.1 weeks. The most common primary CKD etiology was congenital anomalies of the kidney/urinary tract (n = 14, 28.0%). Twenty-three (46.0%) patients received dialysis at the index date and eight (16.0%) had a kidney transplant post-index date. Twenty-eight (56.0%) patients received iron treatment with their index-line ESA. The mean (standard deviation) baseline hemoglobin level was 10.0 (2.0) g/dL. Twenty adverse events (AEs) were recorded in nine (18.0%) patients; all were serious and no inference was sought for attributability to treatment.
CONCLUSIONS: This study demonstrates feasibility of retrospectively extracting clinical characteristics, treatment history, and AEs from medical charts of pediatric patients with anemia of CKD.