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. 2024 Mar;39(3):807-818.
doi: 10.1007/s00467-023-05977-z. Epub 2023 Aug 11.

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

Laura Kohlhas  1 , Milena Studer  2 , Loes Rutten-Jacobs  2 , Sylvie Meyer Reigner  2 , Anja Sander  1 , Hui-Kim Yap  3 , Karel Vondrak  4 , Paula A Coccia  5 , Francisco Cano  6 , Claus Peter Schmitt  7 , Bradley A Warady  8 , Franz Schaefer  9 ; IPDN collaborators
Collaborators, Affiliations

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

Laura Kohlhas et al. Pediatr Nephrol. 2024 Mar.

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.

Keywords: Chronic kidney disease; Continuous erythropoietin receptor activator; Hemodialysis; Peritoneal dialysis; Real-world study.

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Conflict of interest statement

Laura Kohlhas reports research funding for support for third-party writing assistance from F. Hoffmann-La Roche Ltd.

Milena Studer is an employee of F. Hoffmann-La Roche and reports research funding for support for third-party writing assistance from F. Hoffmann-La Roche Ltd.

Loes Rutten-Jacobs is an employee of F. Hoffmann-La Roche Ltd. and owns stock in F. Hoffmann-La Roche and reports research funding for support for third-party writing assistance from F. Hoffmann-La Roche Ltd.

Sylvie Meyer Reigner is an employee of F. Hoffmann-La Roche Ltd and reports research funding for support for third-party writing assistance from F. Hoffmann-La Roche Ltd.

Anja Sander reports research funding for support for third-party writing assistance from F. Hoffmann-La Roche Ltd.

Hui-Kim Yap reports research funding for support for third-party writing assistance from F. Hoffmann-La Roche Ltd.

Karel Vondrak reports research funding for support for third-party writing assistance from F. Hoffmann-La Roche Ltd.

Paula A. Coccia reports consulting fees, lectures and speakers’ bureaus with Fresenius medical care and Alexion, and reports research funding for support for third-party writing assistance from F. Hoffmann-La Roche Ltd.

Francisco Cano reports research funding for support for third-party writing assistance from F. Hoffmann-La Roche Ltd.

Claus Peter Schmitt received consultancy honoraria from Baxter, Iperboreal Pharma, STADAPHARM, and lecturing honoraria from Fresenius and reports research funding for support for third-party writing assistance from F. Hoffmann-La Roche Ltd.

Bradley A. Warady reports paid consultancy activities for Amgen, Fibrogen, Roche, Bayer, and Reata and reports research funding for support for third-party writing assistance from F. Hoffmann-La Roche Ltd.

Franz Schaefer reports paid consultancy activities for Amgen, Akebia, Astellas, and Roche, and reports research funding for support for third-party writing assistance from F. Hoffmann-La Roche Ltd.

Figures

None
A higher resolution version of the Graphical abstract is available as Supplementary information
Fig. 1
Fig. 1
Study CONSORT diagram. HD, hemodialysis; IPHN, International Pediatric Hemodialysis Network; IPPN, International Pediatric Peritoneal Dialysis Network; PD, peritoneal dialysis; C.E.R.A., continuous erythropoietin receptor activator
Fig. 2
Fig. 2
Hemoglobin concentrations over time per age group for PD (left panel) and HD cohort (right panel). Data are shown as mean ± SD per 6-monthly observation (visit). HD, hemodialysis; PD, peritoneal dialysis; SD, standard deviation
Fig. 3
Fig. 3
Monthly C.E.R.A. dose. C.E.R.A. dose normalized to body surface area. C.E.R.A., continuous erythropoietin receptor activator; HD, hemodialysis; PD, peritoneal dialysis
Fig. 3
Fig. 3
Monthly C.E.R.A. dose. C.E.R.A. dose normalized to body surface area. C.E.R.A., continuous erythropoietin receptor activator; HD, hemodialysis; PD, peritoneal dialysis
See this image and copyright information in PMC

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