Subcutaneous CERA for the Treatment of Chronic Renal Anemia in Predialysis Patients

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dc.authoridKazancıoğlu, Rümeyza/0000-0003-1217-588X
dc.authoridDuranay, Murat/0000-0002-2893-4484
dc.authoridYILDIZ, ALAATTIN/0000-0002-4066-929X
dc.authorwosidKazancıoğlu, Rümeyza/AAH-7666-2019
dc.authorwosidDuranay, Murat/HKV-1804-2023
dc.authorwosidYıldız, Alaattin/AAY-6102-2020
dc.contributor.authorUstundag, Sedat
dc.contributor.authorDogan, Ekrem
dc.contributor.authorDuranay, Murat
dc.contributor.authorKazancioglu, Rumeyza
dc.contributor.authorCelik, Vedat
dc.contributor.authorUnsal, Abdulkadir
dc.contributor.authorAltintepe, Lutfullah
dc.date.accessioned2024-06-12T10:56:02Z
dc.date.available2024-06-12T10:56:02Z
dc.date.issued2016
dc.departmentTrakya Üniversitesien_US
dc.description.abstractBackground: We investigated the efficacy, safety and tolerability of once-monthly administration of C.E.R.A. in erythropoiesis stimulating agents (ESAs) naive predialysis patients with CKD for anemia treatment Study Design: Single arm, open label study. Methods: A total of 75 patients (mean (SD) age was 52.8 (16.4) years, 76.0% were female) were included in this study conducted between 12 August 2008 and 30 October 2009 in 9 centers across Turkey. The mean change in Hb concentration (g/dL) between baseline (week 0) and the efficacy evaluation period (EEP) was the primary efficacy parameter evaluated in three consecutive periods including a dose titration period (DTP; with initial 1.2 mu g/kg dose of C.E.R.A., subcutaneously, 28 weeks), EEP (8 weeks) and a long-term safety period (16 weeks). Results: Our analysis revealed an improvement in Hb levels from baseline value of 9.4 (0.4) g/dL to time adjusted average level of 11.4 (0.7) g/dL in EEP in the per protocol (PP) population and from 9.3 (0.5) g/dL to 11.1 (1.0) g/dL in intent-to-treat (ITT) population. Mean (SD) change in Hb levels from baseline to EEP was 2.0 (0.7) g/dl in the PP population (primary endpoint) and 1.7 (1.1) g/dL in the ITT population. The percentage of patients whose Hb concentrations remained within the target range of 10.0-12.0 g/dL throughout the EEP was 43.9% (95% CI: 28.5-60.3%) in the PP population and 38.7% (95% CI: 27.6% to 50.6%) in the ITP population. A total of 206 adverse events (AE) were reported in 77.0% of patients with hypertension (20%) as the most frequent AE. Conclusion: Once-monthly subcutaneous C.E.R.A. administration is effective and safe in the treatment of anemia in pre-dialysis patients with CKD, who are not currently treated with ESAs.en_US
dc.description.sponsorshipRoche Turkeyen_US
dc.description.sponsorshipThis study is granted by Roche Turkey.en_US
dc.identifier.doi10.5152/balkanmedj.2016.141173
dc.identifier.endpage330en_US
dc.identifier.issn2146-3123
dc.identifier.issn2146-3131
dc.identifier.issue3en_US
dc.identifier.pmid27308077en_US
dc.identifier.scopus2-s2.0-84971612089en_US
dc.identifier.scopusqualityQ3en_US
dc.identifier.startpage322en_US
dc.identifier.urihttps://doi.org/10.5152/balkanmedj.2016.141173
dc.identifier.urihttps://hdl.handle.net/20.500.14551/19651
dc.identifier.volume33en_US
dc.identifier.wosWOS:000379332000011en_US
dc.identifier.wosqualityQ3en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherGalenos Publ Houseen_US
dc.relation.ispartofBalkan Medical Journalen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subjectCERAen_US
dc.subjectChronic Kidney Diseaseen_US
dc.subjectEfficacyen_US
dc.subjectHemoglobin Levelsen_US
dc.subjectSafetyen_US
dc.subjectTolerabilityen_US
dc.subjectChronic Kidney-Diseaseen_US
dc.subjectErythropoietin Receptor Activatoren_US
dc.subjectNon-Dialysis Patientsen_US
dc.subjectGlycol-Epoetin-Betaen_US
dc.subjectEvery 4 Weeksen_US
dc.subjectHemoglobin Controlen_US
dc.subjectCorrects Anemiaen_US
dc.subjectHemodialysis-Patientsen_US
dc.subjectMaintains Hemoglobinen_US
dc.subjectStable Hemoglobinen_US
dc.titleSubcutaneous CERA for the Treatment of Chronic Renal Anemia in Predialysis Patientsen_US
dc.typeArticleen_US

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