Efficacy and safety of CKD-11101 (darbepoetin-alfa proposed biosimilar) compared with NESP in anaemic chronic kidney disease patients not on dialysis.

Efficacy and safety of CKD-11101 (darbepoetin-alfa proposed biosimilar) compared with NESP in anaemic chronic kidney disease patients not on dialysis. Curr Med Res Opin. 2018 Dec 20;:1-17 Authors: Lee JH, Chung BH, Joo KW, Shin SK, Kim YL, Na KY, Do JY, Park SK, Shin BC, Lee JS, Kim YW, Kim SW, Lee KW, Kang GW, An WS, Shin GT, Han S, Yang CW Abstract OBJECTIVE: To evaluate the efficacy and safety of CKD-11101 (biosimilar darbepoetin-alfa, Chong Kun Dang Pharm.) compared with NESP® in treatment of anaemia in patients with chronic kidney disease not on dialysis. CLINICAL TRIAL REGISTRATION: NCT03431623. METHOD: In this multicentre, randomized, double-blind study, patients were treated with CKD-11101 and NESP. The efficacy evaluation period (EEP) was 24 weeks, during which patients were treated every 2 weeks. All patients who completed the EEP were treated with CKD-11101 every 2 weeks for the first four weeks and every 4 weeks for the safety evaluation period (SEP), which was from 24 weeks to 52 weeks. The primary efficacy endpoint was the change in mean haemoglobin (Hb) level from baseline to end of EEP and mean dose needed to achieve the target Hb. RESULTS: The mean Hb level was increased in both groups during the EEP (both P 
Source: Current Medical Research and Opinion - Category: Research Tags: Curr Med Res Opin Source Type: research

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The objective of this study was to compare the eff...
Source: BMC Nephrology - Category: Urology & Nephrology Authors: Tags: Research article Source Type: research
Conclusions: Molidustat was well tolerated for up to 36 months and appears to be an effective alternative to darbepoetin and epoetin in the long-term management of anemia associated with CKD.Am J Nephrol 2019;49:271 –280
Source: American Journal of Nephrology - Category: Neurology Source Type: research
CONCLUSIONS: Molidustat was well tolerated for up to 36 months and appears to be an effective alternative to darbepoetin and epoetin in the long-term management of anemia associated with CKD. PMID: 30852574 [PubMed - as supplied by publisher]
Source: American Journal of Nephrology - Category: Urology & Nephrology Authors: Tags: Am J Nephrol Source Type: research
CONCLUSIONS: ESA-treated patients undergoing dialysis incurred lower costs, lower HRU, and had better HRQoL relative to ESA-untreated patients. However, treatment to higher Hb targets led to modest HRQoL improvements compared to lower Hb targets. PMID: 30813807 [PubMed - as supplied by publisher]
Source: Journal of Medical Economics - Category: Health Management Tags: J Med Econ Source Type: research
Abstract Chronic kidney disease (CKD) is associated with several complications that worsen with progression of disease; anemia, disturbances in iron metabolism and inflammation are common features. Inflammatory response starts early, releasing pro-inflammatory cytokines, acute phase reactants and hepcidin. Hepcidin production is modulated by several factors, as hypoxia/anemia, erythropoietin and erythropoiesis products, transferrin saturation (TSAT) and liver iron levels, which are altered in CKD. Treatment of CKD anemia is based on pharmaceutical intervention, with erythropoietic stimulating agents and/or iron su...
Source: Vitamins and Hormones - Category: Endocrinology Authors: Tags: Vitam Horm Source Type: research
CONCLUSIONS: A simple and easy-to-use risk prediction tool utilizing standard clinical parameters identifies TAVR patients at increased risk of 30-day readmission. The tool may consequently inform hospital discharge planning, optimize transitions of care, and reduce resource utilization. PMID: 30803938 [PubMed - as supplied by publisher]
Source: EuroIntervention - Category: Cardiovascular & Thoracic Surgery Tags: EuroIntervention Source Type: research
This article summarizes the milestones in the development of roxadustat leading to this first approval.
Source: Drugs - Category: Drugs & Pharmacology Source Type: research
Ferumoxytol for iron deficiency anemia in patients undergoing hemodialysis. The FACT randomized controlled trial
. Clin Nephrol. 2019 Feb 25;: Authors: Macdougall IC, Strauss WE, Dahl NV, Bernard K, Li Z Abstract BACKGROUND: Patients with chronic kidney disease (CKD) undergoing dialysis often require intravenous iron for iron deficiency anemia (IDA). MATERIALS AND METHODS: The Ferumoxytol for Anemia of CKD Trial (FACT), a randomized, multicenter, open-label, phase 4 study, compared the long-term safety and efficacy of ferumoxytol with iron sucrose for the treatment of IDA in patients ...
Source: Clinical Nephrology - Category: Urology & Nephrology Authors: Tags: Clin Nephrol Source Type: research
Abstract INTRODUCTION: The FIND-CKD study has validated the use of ferric carboxymaltose (FCM) injection with a target of ferritin level between 400 and 600ng/mL to treat iron deficiency anemia in non-dialysis-dependent chronic kidney disease (ND-CKD) patients. In order to assess this strategy in clinical practice, we constituted a cohort of patients within our nephrology department. PATIENTS AND METHODS: Patients had CKD stages 3 to 5, hemoglobin level (Hb)
Source: Nephrologie and Therapeutique - Category: Urology & Nephrology Authors: Tags: Nephrol Ther Source Type: research
CONCLUSIONS: The included studies provide low certainty evidence that IV iron compared with oral iron increases haemoglobin, ferritin and transferrin levels in CKD participants, increases the number of participants who achieve target haemoglobin and reduces ESA requirements. However, there is insufficient evidence to determine whether IV iron compared with oral iron influences death (all causes), cardiovascular death and quality of life though most studies reported only short periods of follow-up. Adverse effects were reported in only 50% of included studies. We therefore suggest that further studies that focus on patient-...
Source: Cochrane Database of Systematic Reviews - Category: General Medicine Authors: Tags: Cochrane Database Syst Rev Source Type: research
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