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Real-world evidence on the dosing and safety of C.E.R.A. in pediatric dialysis patients: findings from the International Pediatric Dialysis Network registries

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Title: Real-world evidence on the dosing and safety of C.E.R.A. in pediatric dialysis patients: findings from the International Pediatric Dialysis Network registries
Authors: Kohlhas, Laura, Studer, Milena, Rutten-Jacobs, Loes, Reigner, Sylvie Meyer, Sander, Anja, Yap, Hui-Kim, Vondrak, Karel, Coccia, Paula A., Cano, Francisco, Schmitt, Claus Peter, Warady, Bradley A., Schaefer, Franz, IPDN collaborators, Yap, Yok-Chin, Ha, Il Soo, Büscher, Rainer, Pape, Lars, Samaille, Charlotte, Drozdz, Dorota, van Hoeck, Koen, Vanegas, Juan Jose, Zambrano, Pedro, Weitz, Marcus, Szczepanska, Maria
Source: Pediatr Nephrol
Publisher Information: Springer Science and Business Media LLC, 2023.
Publication Year: 2023
Subject Terms: Adolescent, Adolescent [MeSH], Humans [MeSH], Prospective Studies [MeSH], Hemoglobins/analysis [MeSH], Treatment Outcome [MeSH], Retrospective Studies [MeSH], What's New in Dialysis, Hemodialysis, Original Article, Chronic kidney disease, Renal Insufficiency, Chronic/therapy [MeSH], Erythropoietin [MeSH], Renal Insufficiency, Chronic/drug therapy [MeSH], Kidney Failure, Chronic/therapy [MeSH], Peritoneal dialysis, Real-world study, Continuous erythropoietin receptor activator, Child [MeSH], Registries [MeSH], Renal Dialysis/adverse effects [MeSH], 3. Good health, Hemoglobins, 03 medical and health sciences, Treatment Outcome, 0302 clinical medicine, Renal Dialysis, Humans, Kidney Failure, Chronic, Prospective Studies, Registries, Renal Insufficiency, Chronic, Child, Erythropoietin, Retrospective Studies
Description: Background This retrospective real-world study used data from two registries, International Pediatric Peritoneal Dialysis Network (IPPN) and International Pediatric Hemodialysis Network (IPHN), to characterize the efficacy and safety of continuous erythropoietin receptor activator (C.E.R.A.) in pediatric patients with chronic kidney disease (CKD) on peritoneal dialysis (PD) or hemodialysis (HD). Methods IPPN and IPHN collect prospective data (baseline and every 6 months) from pediatric PD and HD centers worldwide. Demographics, clinical characteristics, dialysis information, treatment, laboratory parameters, number and causes of hospitalization events, and deaths were extracted for patients on C.E.R.A. treatment (IPPN: 2007–2021; IPHN: 2013–2021). Results We analyzed 177 patients on PD (median age 10.6 years) and 52 patients on HD (median age 14.1 years) who had ≥ 1 observation while being treated with C.E.R.A. The median (interquartile range [IQR]) observation time under C.E.R.A. exposure was 6 (0–12.5) and 12 (0–18) months, respectively. Hemoglobin concentrations were stable over time; respective means (standard deviation) at last observation were 10.9 (1.7) g/dL and 10.4 (1.7) g/dL. Respective median (IQR) monthly C.E.R.A. doses at last observation were 3.5 (2.3–5.1) µg/kg, or 95 (62–145) µg/m2 and 2.1 (1.2–3.4) µg/kg, or 63 (40–98) µg/m2. Non-elective hospitalizations occurred in 102 (58%) PD and 32 (62%) HD patients. Seven deaths occurred (19.8 deaths per 1000 observation years). Conclusions C.E.R.A. was associated with efficient maintenance of hemoglobin concentrations in pediatric patients with CKD on dialysis, and appeared to have a favorable safety profile. The current analysis revealed no safety signals. Graphical abstract
Document Type: Article
Other literature type
Language: English
ISSN: 1432-198X
0931-041X
DOI: 10.1007/s00467-023-05977-z
Access URL: https://pubmed.ncbi.nlm.nih.gov/37566114
https://link.springer.com/article/10.1007/s00467-023-05977-z
https://doi.org/10.1007/s00467-023-05977-z
https://repository.publisso.de/resource/frl:6518468
Rights: CC BY
Accession Number: edsair.doi.dedup.....d533e6afd5815d17e103dc9f27ec6750
Database: OpenAIRE
Description
Abstract:Background This retrospective real-world study used data from two registries, International Pediatric Peritoneal Dialysis Network (IPPN) and International Pediatric Hemodialysis Network (IPHN), to characterize the efficacy and safety of continuous erythropoietin receptor activator (C.E.R.A.) in pediatric patients with chronic kidney disease (CKD) on peritoneal dialysis (PD) or hemodialysis (HD). Methods IPPN and IPHN collect prospective data (baseline and every 6 months) from pediatric PD and HD centers worldwide. Demographics, clinical characteristics, dialysis information, treatment, laboratory parameters, number and causes of hospitalization events, and deaths were extracted for patients on C.E.R.A. treatment (IPPN: 2007–2021; IPHN: 2013–2021). Results We analyzed 177 patients on PD (median age 10.6 years) and 52 patients on HD (median age 14.1 years) who had ≥ 1 observation while being treated with C.E.R.A. The median (interquartile range [IQR]) observation time under C.E.R.A. exposure was 6 (0–12.5) and 12 (0–18) months, respectively. Hemoglobin concentrations were stable over time; respective means (standard deviation) at last observation were 10.9 (1.7) g/dL and 10.4 (1.7) g/dL. Respective median (IQR) monthly C.E.R.A. doses at last observation were 3.5 (2.3–5.1) µg/kg, or 95 (62–145) µg/m2 and 2.1 (1.2–3.4) µg/kg, or 63 (40–98) µg/m2. Non-elective hospitalizations occurred in 102 (58%) PD and 32 (62%) HD patients. Seven deaths occurred (19.8 deaths per 1000 observation years). Conclusions C.E.R.A. was associated with efficient maintenance of hemoglobin concentrations in pediatric patients with CKD on dialysis, and appeared to have a favorable safety profile. The current analysis revealed no safety signals. Graphical abstract
ISSN:1432198X
0931041X
DOI:10.1007/s00467-023-05977-z