دورية أكاديمية
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.
| العنوان: | 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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| المؤلفون: | Kohlhas L; Institute of Medical Biometry, University of Heidelberg, Heidelberg, Germany., Studer M; F. Hoffmann-La Roche Ltd, Basel, Switzerland., Rutten-Jacobs L; F. Hoffmann-La Roche Ltd, Basel, Switzerland., Reigner SM; F. Hoffmann-La Roche Ltd, Basel, Switzerland., Sander A; Institute of Medical Biometry, University of Heidelberg, Heidelberg, Germany., Yap HK; Department of Paediatrics, Yong Loo Lin School of Medicine, National University of Singapore, Singapore, Republic of Singapore., Vondrak K; Department of Pediatrics and Transplantation Center, University Hospital Motol, 2nd Medical Faculty Prague, Charles University Prague, Prague, Czech Republic., Coccia PA; Division of Pediatric Nephrology, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina., Cano F; Division of Pediatric Nephrology, Hospital Dr. Luis Calvo Mackenna, Facultad de Medicina, Universidad de Chile, Santiago, Chile., Schmitt CP; Division of Pediatric Nephrology, Center for Pediatrics and Adolescent Medicine, Heidelberg, Germany., Warady BA; Division of Pediatric Nephrology, Children's Mercy Kansas City, Kansas City, MO, USA., Schaefer F; Division of Pediatric Nephrology, Center for Pediatrics and Adolescent Medicine, Heidelberg, Germany. Franz.Schaefer@med.uni-heidelberg.de. |
| مؤلفون مشاركون: | IPDN collaborators |
| المصدر: | Pediatric nephrology (Berlin, Germany) [Pediatr Nephrol] 2024 Mar; Vol. 39 (3), pp. 807-818. Date of Electronic Publication: 2023 Aug 11. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Springer International Country of Publication: Germany NLM ID: 8708728 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1432-198X (Electronic) Linking ISSN: 0931041X NLM ISO Abbreviation: Pediatr Nephrol Subsets: MEDLINE |
| أسماء مطبوعة: | Publication: Berlin : Springer International Original Publication: Berlin : Springer International, c1987- |
| مواضيع طبية MeSH: | Erythropoietin* , Renal Insufficiency, Chronic*/therapy , Renal Insufficiency, Chronic*/drug therapy , Kidney Failure, Chronic*/therapy, Humans ; Child ; Adolescent ; Renal Dialysis/adverse effects ; Retrospective Studies ; Prospective Studies ; Hemoglobins/analysis ; Treatment Outcome ; Registries |
| مستخلص: | 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/m 2 and 2.1 (1.2-3.4) µg/kg, or 63 (40-98) µg/m 2 . 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. (© 2023. The Author(s).) |
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| فهرسة مساهمة: | Investigator: K Vondrak; PA Coccia; YC Yap; HK Yap; F Cano; IS Ha; R Büscher; L Pape; C Samaille; BA Warady; D Drozdz; K van Hoeck; JJ Vanegas; P Zambrano; M Weitz; M Szczepanska Keywords: Chronic kidney disease; Continuous erythropoietin receptor activator; Hemodialysis; Peritoneal dialysis; Real-world study |
| المشرفين على المادة: | 0 (Hemoglobins) 11096-26-7 (Erythropoietin) |
| تواريخ الأحداث: | Date Created: 20230811 Date Completed: 20240129 Latest Revision: 20240410 |
| رمز التحديث: | 20240411 |
| مُعرف محوري في PubMed: | PMC10817843 |
| DOI: | 10.1007/s00467-023-05977-z |
| PMID: | 37566114 |
| قاعدة البيانات: | MEDLINE |
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Full Text Finder | تدمد: | 1432-198X |
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| DOI: | 10.1007/s00467-023-05977-z |