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Once-Monthly Continuous Erythropoietin Receptor Activator (C.E.R.A.) in Patients with Hemodialysis-Dependent Chronic Kidney Disease: Pooled Data from Phase III Trials
- Source :
- Advances in Therapy
- Publication Year :
- 2016
-
Abstract
- Introduction Erythropoiesis-stimulating agents and iron are commonly used in patients with chronic kidney disease with the aim of correcting anemia and maintaining stable hemoglobin levels. We analyzed pooled data from 13 studies with similar designs included in the Umbrella Continuous Erythropoietin Receptor Activator (C.E.R.A.) program to investigate the effects of continuous erythropoiesis receptor activator in clinically relevant subgroups of patients with chronic kidney disease and to determine whether the efficacy and safety outcomes demonstrated in the overall chronic kidney disease population are maintained in specific subgroups. Methods Data from 13 Phase III trials set up with similar design were retrospectively pooled for this analysis. Patients with chronic kidney disease who had previously been receiving epoetin or darbepoetin were switched to continuous erythropoiesis receptor activator once-monthly after a 4- to 8-week screening period. Patients entered a 16-week continuous erythropoiesis receptor activator dose-titration period followed by an 8-week evaluation period. In total, 2060 patients were included in the analysis. Subgroups were defined based on: hemoglobin target range [lower (10.0–12.0 g/dL)/upper (10.5–13.0 g/dL)], gender (female/male), age (
- Subjects :
- Male
medicine.medical_treatment
Statistics as Topic
030232 urology & nephrology
030204 cardiovascular system & hematology
Gastroenterology
Polyethylene Glycols
Hemoglobins
0302 clinical medicine
Pharmacology (medical)
Anemia, chronic kidney disease
Randomized Controlled Trials as Topic
Original Research
Medicine(all)
education.field_of_study
Anemia
General Medicine
Middle Aged
Outcome and Process Assessment, Health Care
Hemodialysis
Erythropoiesis
Female
Continuous erythropoiesis
medicine.drug
medicine.medical_specialty
Efficacy
Population
Pooled analysis
Receptor activator
03 medical and health sciences
Renal Dialysis
Internal medicine
medicine
Humans
Renal Insufficiency, Chronic
education
Erythropoietin
Aged
Dose-Response Relationship, Drug
Activator (genetics)
business.industry
medicine.disease
Continuous erythropoietin receptor activator
Clinical Trials, Phase III as Topic
Immunology
Hematinics
Patient subgroups
business
Kidney disease
Subjects
Details
- ISSN :
- 18658652
- Volume :
- 33
- Issue :
- 4
- Database :
- OpenAIRE
- Journal :
- Advances in therapy
- Accession number :
- edsair.doi.dedup.....a2fcbfca9c4cebf08b6b1bc0b41c8e49