Comparative Study of the Efficacy and Safety of BCD-131 and Mircera in Treatment of Anemia in Chronic Kidney Disease Patients on Dialysis

Condition:   Anemia Interventions:   Biological: BCD-131;   Biological: Mircera Sponsor:   Biocad Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials

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Conclusions: Higher MCV was associated with higher all-cause, cardiovascular, and infectious mortality in HD patients. Further investigation is necessary to understand the underlying nature of the observed association.Nephron
Source: Nephron - Category: Urology & Nephrology Source Type: research
Erythropoiesis-stimulating agents (ESAs) are frequently used among patients with renal anemia, while a significant proportion of patients exhibit ESA hyporesponsiveness despite adequate dosing. Previous studies have suggested an inverse association between ESA hyporesponsiveness and statin use among patients receiving dialysis therapy. However, studies based on predialysis patients are extremely limited. Based on electronic medical records of a tertiary hospital in Beijing, China between April 2010 and April 2015, we investigated the association between statin use and ESA hyporesponsiveness among patients with predialysis...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Observational Study Source Type: research
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 tre...
Source: Current Medical Research and Opinion - Category: Research Tags: Curr Med Res Opin Source Type: research
Publication date: Available online 19 December 2018Source: American Journal of Kidney DiseasesAuthor(s): Finnian R. Mc Causland, Brian Claggett, Emmanuel A. Burdmann, Glenn M. Chertow, Mark E. Cooper, Kai-Uwe Eckardt, Peter Ivanovich, Andrew S. Levey, Eldrin F. Lewis, Janet B. McGill, John J.V. McMurray, Patrick Parfrey, Hans-Henrik Parving, Giuseppe Remuzzi, Ajay K. Singh, Scott D. Solomon, Robert D. Toto, Marc A. PfefferRationale &ObjectiveEvidence from clinical trials to guide patient preparation for maintenance dialysis therapy is limited. Although anemia is associated with mortality and cardiovascular (CV) disease...
Source: American Journal of Kidney Diseases - Category: Urology & Nephrology Source Type: research
To win its first-ever drug approval, FibroGen Inc. turned to China, but it's not going to be the San Francisco company's last stop. China's drug regulatory agency Monday approved roxadustat, the first drug of its kind for dialysis patients with anemia caused by chronic kidney disease. San Francisco-based FibroGen's (NASDAQ: FGEN) China subsidiary will manufacture the tablet and partner AstraZeneca plc (NYSE: AZN) will sell the drug starting in the second-half of 2019. But roxadustat's win in China…
Source: bizjournals.com Health Care:Biotechnology headlines - Category: Biotechnology Authors: Source Type: news
CONCLUSIONS: The overall phase 2 efficacy and safety profile of molidustat in patients with CKD and anemia enables the progression of its development into phase 3. PMID: 30559105 [PubMed - as supplied by publisher]
Source: Clinical Journal of the American Society of Nephrology : CJASN - Category: Urology & Nephrology Authors: Tags: Clin J Am Soc Nephrol Source Type: research
Publication date: Available online 13 December 2018Source: The Lancet HIVAuthor(s): Joseph J Eron, Jean-Daniel Lelievre, Robert Kalayjian, Jihad Slim, Anson K Wurapa, Jeffrey L Stephens, Cheryl McDonald, Eric Cua, Aimee Wilkin, Brigitte Schmied, Mehri McKellar, Stephanie Cox, Sophia R Majeed, Shuping Jiang, Andrew Cheng, Moupali Das, Devi SenGuptaSummaryBackgroundCurrent treatment for HIV-infected individuals with renal failure on haemodialysis frequently requires complex regimens with multiple pills. A daily single-tablet regimen of coformulated elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide is approve...
Source: The Lancet HIV - Category: Infectious Diseases Source Type: research
IntroductionIron deficiency anemia (IDA) is the leading cause of anemia in the United States. Although oral iron formulations can correct IDA, they are generally poorly tolerated due to gastrointestinal side effects and may require long term use to maintain normal hemoglobin. Intravenous iron is an alternative to oral iron especially in adults who cannot tolerate or absorb oral iron. Intravenous iron preparations avoid problems of malabsorption and can quickly correct IDA but little data exists on the safety or efficacy in patients without chronic kidney disease (CKD) with or without dialysis, heart failure, uterine bleedi...
Source: Blood - Category: Hematology Authors: Tags: 901. Health Services Research-Non-Malignant Conditions Source Type: research
The objective of this analysis was to assess the importance of parenteral iron dosing on serum hemoglobin (Hgb) level normalization in real world clinical practice.MethodsData was obtained from the Decision Resources Group (DRG) Real World Evidence Data Repository US database, which includes medical and pharmacy claims, and electronic health record data representing more than 300 million patient lives. Adult patients (≥18 years of age) who were treated with parenteral iron between 3/1/2015 and 2/28/2017 were included in the analysis. Eligible patients were required to have their most recent baseline Hgb level below normal (Hgb
Source: Blood - Category: Hematology Authors: Tags: 903. Outcomes Research-Non-Malignant Hematology: Poster I Source Type: research
Hemoglobin concentration (g/L; black circles), deviation (%) from idealized plasma volume (PV (%); white bars) and deviation (%) from idealized red blood cell volume (RBCV (%); grey bars) in non ‐anemic (left from vertical dotted line) and anemic (right from vertical dotted line) CKD male patients. This figure illustrates the fact that most patients with anemia in predialysis CKD have an increase in plasma volume and a relatively normal RBCV, supporting the fact that anemia of CKD may oft en be dilutional. AbstractAnemia is defined according to decreased blood hemoglobin concentration ([Hb]), which is considered a marker...
Source: Physiological Reports - Category: Physiology Authors: Tags: Original Research Source Type: research
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