Objective: The Gain effectiveness in Anaemia treatment wIth NeoRecormon (epoetin beta) study (GAIN) evaluated the effectiveness and safety of recombinant human erythropoietin beta in correcting and/or maintaining common haemoglobin (Hb) targets in routine clinical practice in Europe.
Research Design And Methods: European 18-month observational, prospective clinical practice study across 217 centres from 13 countries. During a 3-month retrospective period, patients received any erythropoiesis stimulating agent (ESA). For the subsequent 18-month study phase, patients receiving intravenous (IV) epoetin beta or any other ESA were recommended to be switched to subcutaneous (SC) epoetin beta. Presence of anti-erythropoietin antibodies (AEAB) and related outcomes was investigated before and during the study.
Clinical Trial Registration: ClinicalTrials.gov number: NCT00551603.
Main Outcome Measures: Correction and maintenance of Hb levels within recommended target range and mean dose requirement to correct and maintain target Hb levels.
Results: A total of 4264 patients on haemodialysis received an ESA for treatment of renal anaemia. During the study period, the number of patients who maintained Hb levels in the recommended target range of 10-12 g/dL increased from 57% to 62%. Administration of SC epoetin beta resulted in a 24% lower mean dose requirement to maintain target Hb levels compared to IV administration (p < 0.001). Considerable differences were observed between countries in the study. No patients developed pure red cell aplasia associated with AEAB during observation.
Conclusion: This observational study suggests that haemodialysis patients who are receiving any ESA via SC or IV administration for treatment of their renal anaemia can be safely and effectively switched to SC epoetin beta to achieve or maintain the currently recommended Hb targets. SC required a lower dose than IV administration to maintain similar efficacy, thereby potentially lowering the drug costs.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1185/03007990902784459 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Vadadustat Three Times Weekly in Patients With Anemia Due to Dialysis-Dependent CKD.
Am J Kidney Dis
November 2024
Emory University School of Medicine, Atlanta, GA.
Article Synopsis
- The study investigates the effectiveness and safety of using vadadustat, a hypoxia-inducible factor prolyl hydroxylase inhibitor, as an alternative to the erythropoiesis-stimulating agent methoxy polyethylene glycol-epoetin beta (MPG-EPO) in treating anemia for patients with chronic kidney disease (CKD) who are on dialysis.
- This Phase 3b trial involved 456 adult participants, randomized into three groups receiving either vadadustat (at two different doses) or MPG-EPO, for up to 52 weeks, with a focus on changes in hemoglobin levels.
- Results showed that vadadustat was noninferior to MPG-EPO regarding hemoglobin change
Roxadustat for Treating Anemia in Patients with Advanced Chronic Kidney Disease Not Undergoing Dialysis: A Retrospective Study.
Intern Med
October 2024
Department of Nephrology, Tokushima University Hospital, Japan.
Objective Roxadustat, a hypoxia-inducible factor-prolyl hydroxylase inhibitor, increases the hemoglobin (Hb) levels in patients with chronic kidney disease (CKD). To date, limited clinical studies have focused on the excessive increase in the Hb levels in the early weeks after switching from erythropoiesis-stimulating agents (ESA) to roxadustat in adult non-dialysis patients. We conducted a retrospective study to examine whether early overshoot frequently occurs after switching to roxadustat.
View Article and Find Full Text PDFDiscovery of Biomarkers of a Recombinant Human Erythropoietin Administration to Thoroughbred Geldings by Label-Free Proteomics.
Drug Test Anal
September 2024
Racing Laboratory, The Hong Kong Jockey Club, Sha Tin Racecourse, Sha Tin, Hong Kong, China.
Erythropoiesis-stimulating agents (ESAs) continue to be a significant threat to the integrity of human and equine sports. Besides conventional direct testing, monitoring the biomarkers associated with the effects of ESAs may provide a complementary approach via indirect detection to enhance doping control. In this study, we applied label-free proteomics to discover plasma protein biomarkers in Thoroughbred geldings after administration with a long-acting form of recombinant human erythropoietin (rhEPO), methoxy polyethylene glycol epoetin beta, Mircera.
View Article and Find Full Text PDFSeparation of recombinant erythropoietin and human serum albumin without the use of sophisticated equipment.
Anal Biochem
January 2025
M.M. Shemyakin and Yu.A. Ovchinnikov Institute of Bioorganic Chemistry, Russian Academy of Sciences, 117997, Moscow, Russia.
A number of drugs based on recombinant erythropoietin contain human serum albumin as an auxiliary component. The presence of this protein hinders the proper control of the drug quality in accordance with the requirements of regulating agencies. We propose the novel method for separation of recombinant erythropoietin (epoetin beta) and human serum albumin.
View Article and Find Full Text PDFEnhanced analysis of equine plasma for the presence of recombinant human erythropoietin - Implementation of an improved workflow.
Drug Test Anal
August 2024
Australian Racing Forensic Laboratory, Racing NSW, Sydney, NSW, Australia.
An improved screening workflow and a robust capillary flow LC-MS confirmatory method for the detection of recombinant human erythropoietin (rHuEPO) has been implemented to increase the sensitivity of rHuEPO detection and to reduce the number of suspect samples committed to confirmatory testing. The influence of repeated dosing of epoetin-β on the detection window of rHuEPO in equine plasma was assessed using the optimised method. Samples were initially assessed using an economical R&D Human EPO Duo-Set ELISA Development System.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!