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Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Chronic Renal Failure
recomon (Epoetin Beta), recomon (Epoetin Beta)
Eulji University Hospital
Korea, Republic of
ChoongWae Pharma Corporation
Published on BioPortfolio: 2014-08-27T03:14:11-0400
This two arm study will compare the maintenance of hemoglobin levels, safety and tolerability of once every 4 weeks subcutaneous administration of Mircera versus epoetin beta in dialysis p...
RATIONALE: Epoetin alfa and epoetin beta may cause the body to make more red blood cells. Red blood cells contain iron that is needed to carry oxygen to the tissues. It is not yet known wh...
This open-label single-arm study will evaluate the efficacy, safety and tolerabi lity of methoxy polyethylene glycol epoetin beta on long-term maintenance of hae moglobin levels in patient...
This study will assess the efficacy and safety of intravenous Mircera, given as maintenance treatment for renal anemia in chronic kidney disease patients on dialysis who were previously re...
This study will assess the efficacy and safety of subcutaneous (sc) Mircera give n as maintenance treatment for renal anemia in chronic kidney disease patients o n dialysis who were previo...
Anemia is one of the most prevalent complications in patients with chronic kidney disease, which is believed to be caused by the insufficient synthesis of erythropoietin by the kidney. This phase III ...
For patients with anemia undergoing hemodialysis, erythropoiesis-stimulating agents (ESAs) are typically dosed via precise algorithms. Using one such algorithm, we assessed the maintenance of hemoglob...
Effect of achieved hemoglobin level on renal outcome in non-dialysis chronic kidney disease (CKD) patients receiving epoetin beta pegol: MIRcerA CLinical Evidence on Renal Survival in CKD patients with renal anemia (MIRACLE-CKD Study).
Previous randomized-controlled trials have shown that targeting higher hemoglobin (Hb) levels using high dose of ESA in non-dialysis chronic kidney disease (NDCKD) patients resulted in poorer cardiova...
Erythropoiesis-stimulating agents (ESAs) are biological molecules approved for the treatment of anemia associated with chronic renal failure. Biosimilars were licensed for use in Europe in 2007.
Unexpected serious adverse drug reactions (sADRs) affecting patients with chronic kidney disease (CKD) who received erythropoiesis-stimulating agents were identified by study co-authors. These include...
This recombinant erythropoietin, a 165-amino acid glycoprotein (about 62% protein and 38% carbohydrate), regulates red blood cell production. Epoetin alfa is produced by Chinese hamster ovary cells into which the human erythropoietin gene has been inserted. (USP Dictionary of USAN and International Drug Names, 1996).
A group of enzymes that catalyzes the hydrolysis of terminal, non-reducing beta-D-galactose residues in beta-galactosides. Deficiency of beta-Galactosidase A1 may cause GANGLIOSIDOSIS, GM1.
An exocellulase with specificity for 1,3-beta-D-glucasidic linkages. It catalyzes hydrolysis of beta-D-glucose units from the non-reducing ends of 1,3-beta-D-glucans, releasing GLUCOSE.
Members of the beta-globin family. In humans, they are encoded in a gene cluster on CHROMOSOME 11. They include epsilon-globin, gamma-globin, delta-globin and beta-globin. There is also a pseudogene of beta (theta-beta) in the gene cluster. Adult HEMOGLOBIN is comprised of two ALPHA-GLOBIN chains and two beta-globin chains.
The beta subunit of luteinizing hormone. It is a 15-kDa glycopolypeptide with structure similar to the beta subunit of the placental chorionic gonadatropin (CHORIONIC GONADOTROPIN, BETA SUBUNIT, HUMAN) except for the additional 31 amino acids at the C-terminal of CG-beta. Full biological activity of LH requires the non-covalently bound heterodimers of an alpha and a beta subunit. Mutation of the LHB gene causes HYPOGONADISM and infertility.
Blood is a specialized bodily fluid that delivers necessary substances to the body's cells (in animals) – such as nutrients and oxygen – and transports waste products away from those same cells. In vertebrates, it is composed of blo...
In medicine, dialysis is a process for removing waste and excess water from the blood, and is primarily used to provide an artificial replacement for lost kidney function in people with renal failure. Dialysis may be used for those with an acute disturba...