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Latest Cinacalcet Stories

2014-08-18 16:28:18

Second Phase 3 Registrational Study Meets Primary and All Secondary Endpoints THOUSAND OAKS, Calif., Aug. 18, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that a second placebo-controlled Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis, met its primary and all secondary endpoints. The primary endpoint was the proportion of patients with > 30 percent...

2014-07-17 16:26:20

Analysis Shows Study Met Primary and All Secondary Endpoints THOUSAND OAKS, Calif., July 17, 2014 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that a Phase 3 study evaluating AMG 416 (formerly known as velcalcetide) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis, met its primary and all secondary endpoints. The primary endpoint was the proportion of patients with > 30 percent reduction from...

2013-05-01 12:36:38

Cinacalcet, a drug commonly given to patients with end stage kidney disease to help keep phosphorus and parathyroid blood levels within a target range and has few patient level clinical benefits and several adverse effects, suggesting that it should no longer be routinely prescribed, according to a study by international researchers published in this week's PLOS Medicine. These findings are important as cinacalcet has become the largest single drug cost for patients on dialysis in the US,...

Pediatric Trial Of Amgen's Sensipar Halted After Teen Death
2013-02-27 05:58:10

redOrbit Staff & Wire Reports - Your Universe Online Officials with the US Food and Drug Administration (FDA) have halted a trial of the thyroid drug Sensipar following the death of a 14-year-old patient during clinical trials, various media outlets reported Tuesday. According to the Associated Press (AP), officials from the regulatory agency are still gathering information about the incident. However, in the meantime they have ordered the drug´s manufacturer, biopharmaceutical...

2012-11-05 15:06:16

In one of the largest and longest trials involving patients with kidney failure, a study led by an international team of researchers found that cinacalcet – a drug commonly prescribed to patients with kidney failure and a disturbance of bone and mineral metabolism known as secondary hyperparathyroidism – does not significantly reduce the risk of death or major cardiovascular events. The results of the trial known as EVOLVE, which enrolled nearly 4,000 kidney patients from...

2011-06-28 08:51:00

PRAGUE, June 28, 2011 /PRNewswire/ -- The 48th ERA-EDTA congress was the setting for a wide range of new clinical data. The "Late-Breaking Clinical Trials" were met with particular interest, one of them being the IMPACT SHPT study (Evaluation of the Effectiveness of Paricalcitol Versus Cinacalcet With Low-Dose Vitamin D). In the oral presentation on 25 June the principal investigator of this study, Prof. Markus Ketteler (Coburg, Germany), summarized the final data, whereas the...

2011-06-25 09:30:00

PRAGUE, June 25, 2011 /PRNewswire/ -- The SHARP-study has shown that lowering LDL cholesterol with ezetimibe/simvastatinleads to a significant reduction in major atherosclerotic events among CKD-patients. Whether it also has a favourable effect on renal disease progression was another of the issues addressed by the SHARP study [abstract no. 2509]. In the ezetimibe/simvastatin group, fewer patients reached the end point "end stage renal disease", but the difference was not...


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