FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W4313333048> ?p ?o ?g. }

• W4313333048 endingPage "694.e1" @default.
• W4313333048 startingPage "684" @default.
• W4313333048 abstract "Rationale & Objective The optimum starting dose of intravenous continuous erythropoietin receptor activator (C.E.R.A.) has been previously determined; this study ascertains the optimum starting dose of subcutaneous C.E.R.A. administration in pediatric patients. Study Design Phase 2, open-label, single-arm, multicenter study. Setting & Participants Patients aged 3 months to 17 years with renal anemia and chronic kidney disease (CKD; including those treated with maintenance dialysis and those not treated with dialysis) who were receiving maintenance treatment with erythropoiesis-stimulating agents (ESAs). Intervention Subcutaneous C.E.R.A. administration every 4 weeks (starting dose was based on defined conversion factors). Outcome The primary outcome was the change in hemoglobin concentration between the baseline and evaluation period for each patient. Secondary efficacy measures and safety were also evaluated. Results Forty patients aged 0.4-17.7 years were enrolled. The study achieved its primary outcome: the mean change in hemoglobin concentration was an increase of 0.48 g/dL; the 95% confidence interval (0.15-0.82) and standard deviation (±1.03) were within the prespecified boundaries (−1 to 1 g/dL and <1.5 g/dL, respectively). Mean hemoglobin concentrations were maintained within the target 10-12 g/dL range in 24 of 38 patients and within ±1 g/dL of the baseline in 19 of 38 patients, and the median C.E.R.A. subcutaneous dose decreased over time. Efficacy in key subgroups (age group, dialysis type, prior ESA treatment) was consistent with the primary outcome. Thirty-eight patients completed the core period; 25 chose to enter the safety extension period. Safety was consistent with prior studies, with no new signals. Limitations Single-arm and open-label study; small sample size. Conclusions Pediatric patients with anemia secondary to CKD who were on, or not on, dialysis could be safely and effectively switched from maintenance ESAs to subcutaneous C.E.R.A. administered every 4 weeks, using defined dose-conversion factors to determine the optimum starting dose. Funding F. Hoffmann-La Roche Ltd. Trial Registration The SKIPPER trial registered at ClinicalTrials.gov with study number NCT03552393. Plain-Language Summary Anemia, a complication of chronic kidney disease, is associated with poor quality of life and an increased risk of hospitalization and mortality. The current treatments for anemia include iron therapy and erythropoiesis-stimulating agents (ESAs); however, the relatively short half-lives of the ESAs epoetin alfa/beta or darbepoetin alfa may require more frequent dosing and hospital visits compared with the ESA known as continuous erythropoietin receptor activator (C.E.R.A.). A previous study demonstrated that children aged 5 years or more with anemia associated with chronic kidney disease who were on hemodialysis could be switched to intravenous C.E.R.A. from their existing epoetin alfa/beta or darbepoetin alfa treatment. This study provides evidence that subcutaneous C.E.R.A. can safely and effectively treat anemia in children, including those aged <5 years and regardless of whether they were on dialysis or the type of dialysis they received (peritoneal dialysis or hemodialysis). The optimum starting dose of intravenous continuous erythropoietin receptor activator (C.E.R.A.) has been previously determined; this study ascertains the optimum starting dose of subcutaneous C.E.R.A. administration in pediatric patients. Phase 2, open-label, single-arm, multicenter study. Patients aged 3 months to 17 years with renal anemia and chronic kidney disease (CKD; including those treated with maintenance dialysis and those not treated with dialysis) who were receiving maintenance treatment with erythropoiesis-stimulating agents (ESAs). Subcutaneous C.E.R.A. administration every 4 weeks (starting dose was based on defined conversion factors). The primary outcome was the change in hemoglobin concentration between the baseline and evaluation period for each patient. Secondary efficacy measures and safety were also evaluated. Forty patients aged 0.4-17.7 years were enrolled. The study achieved its primary outcome: the mean change in hemoglobin concentration was an increase of 0.48 g/dL; the 95% confidence interval (0.15-0.82) and standard deviation (±1.03) were within the prespecified boundaries (−1 to 1 g/dL and <1.5 g/dL, respectively). Mean hemoglobin concentrations were maintained within the target 10-12 g/dL range in 24 of 38 patients and within ±1 g/dL of the baseline in 19 of 38 patients, and the median C.E.R.A. subcutaneous dose decreased over time. Efficacy in key subgroups (age group, dialysis type, prior ESA treatment) was consistent with the primary outcome. Thirty-eight patients completed the core period; 25 chose to enter the safety extension period. Safety was consistent with prior studies, with no new signals. Single-arm and open-label study; small sample size. Pediatric patients with anemia secondary to CKD who were on, or not on, dialysis could be safely and effectively switched from maintenance ESAs to subcutaneous C.E.R.A. administered every 4 weeks, using defined dose-conversion factors to determine the optimum starting dose." @default.
• W4313333048 created "2023-01-06" @default.
• W4313333048 creator A5027825347 @default.
• W4313333048 creator A5040268450 @default.
• W4313333048 creator A5055442551 @default.
• W4313333048 creator A5090860493 @default.
• W4313333048 date "2023-06-01" @default.
• W4313333048 modified "2023-10-05" @default.
• W4313333048 title "Subcutaneous C.E.R.A. for the Maintenance Treatment of Anemia in Pediatric Patients With CKD: A Phase 2, Open-Label, Single-Arm, Multicenter Study" @default.
• W4313333048 cites W1971141490 @default.
• W4313333048 cites W1991943756 @default.
• W4313333048 cites W2024817920 @default.
• W4313333048 cites W2026537001 @default.
• W4313333048 cites W2048489207 @default.
• W4313333048 cites W2060765415 @default.
• W4313333048 cites W2061634360 @default.
• W4313333048 cites W2097568030 @default.
• W4313333048 cites W2104810766 @default.
• W4313333048 cites W2105662273 @default.
• W4313333048 cites W2130240434 @default.
• W4313333048 cites W2149688292 @default.
• W4313333048 cites W2158326404 @default.
• W4313333048 cites W2176266812 @default.
• W4313333048 cites W2549976897 @default.
• W4313333048 cites W2765297468 @default.
• W4313333048 cites W2990529293 @default.
• W4313333048 cites W3095056029 @default.
• W4313333048 doi "https://doi.org/10.1053/j.ajkd.2022.11.006" @default.
• W4313333048 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/36587890" @default.
• W4313333048 hasPublicationYear "2023" @default.
• W4313333048 type Work @default.
• W4313333048 citedByCount "1" @default.
• W4313333048 countsByYear W43133330482023 @default.
• W4313333048 crossrefType "journal-article" @default.
• W4313333048 hasAuthorship W4313333048A5027825347 @default.
• W4313333048 hasAuthorship W4313333048A5040268450 @default.
• W4313333048 hasAuthorship W4313333048A5055442551 @default.
• W4313333048 hasAuthorship W4313333048A5090860493 @default.
• W4313333048 hasConcept C126322002 @default.
• W4313333048 hasConcept C141071460 @default.
• W4313333048 hasConcept C2778248108 @default.
• W4313333048 hasConcept C2778534260 @default.
• W4313333048 hasConcept C2778653478 @default.
• W4313333048 hasConcept C2778917026 @default.
• W4313333048 hasConcept C2779978075 @default.
• W4313333048 hasConcept C2781404941 @default.
• W4313333048 hasConcept C44249647 @default.
• W4313333048 hasConcept C71924100 @default.
• W4313333048 hasConcept C90924648 @default.
• W4313333048 hasConceptScore W4313333048C126322002 @default.
• W4313333048 hasConceptScore W4313333048C141071460 @default.
• W4313333048 hasConceptScore W4313333048C2778248108 @default.
• W4313333048 hasConceptScore W4313333048C2778534260 @default.
• W4313333048 hasConceptScore W4313333048C2778653478 @default.
• W4313333048 hasConceptScore W4313333048C2778917026 @default.
• W4313333048 hasConceptScore W4313333048C2779978075 @default.
• W4313333048 hasConceptScore W4313333048C2781404941 @default.
• W4313333048 hasConceptScore W4313333048C44249647 @default.
• W4313333048 hasConceptScore W4313333048C71924100 @default.
• W4313333048 hasConceptScore W4313333048C90924648 @default.
• W4313333048 hasIssue "6" @default.
• W4313333048 hasLocation W43133330481 @default.
• W4313333048 hasLocation W43133330482 @default.
• W4313333048 hasOpenAccess W4313333048 @default.
• W4313333048 hasPrimaryLocation W43133330481 @default.
• W4313333048 hasRelatedWork W1964706798 @default.
• W4313333048 hasRelatedWork W1964765226 @default.
• W4313333048 hasRelatedWork W2100854655 @default.
• W4313333048 hasRelatedWork W2102686764 @default.
• W4313333048 hasRelatedWork W2411675837 @default.
• W4313333048 hasRelatedWork W2560740343 @default.
• W4313333048 hasRelatedWork W2618912176 @default.
• W4313333048 hasRelatedWork W3029234346 @default.
• W4313333048 hasRelatedWork W4377864077 @default.
• W4313333048 hasRelatedWork W2320943530 @default.
• W4313333048 hasVolume "81" @default.
• W4313333048 isParatext "false" @default.
• W4313333048 isRetracted "false" @default.
• W4313333048 workType "article" @default.