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Paricalcitol Injection |
paricalcitol; Zemplar |
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of 7 5 mcg three times per week demonstrated that mean serum Ca P and Ca x P remained within clinically appropriate ranges with PTH reduction mean decrease of 319 pg mL at 13 months REFERENCES 1 K DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease Am J Kidney Dis 2003 Volume 42 4 Supplement 3
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Long Term Impact on Ca and P Zemplar consistently maintained calcium and phosphorus levels within target ranges in long term studies 1 2 Open label multicenter long term study of 164 CKD stage 5 patients lasting up to 13 months in duration After a baseline or washout period Zemplar was administered 2 3 times per
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59 mean reduction in iPTH achieved by month 13 Mean PTH over time for all treated patients 1 Open label multicenter long term study of 164 CKD stage 5 patients lasting up to 13 months in duration After a baseline or washout period ZEMPLAR IV was administered 2 to 3 times
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Mean change in serum phosphorus levels from baseline to study end 1 Open label multicenter long term study of 164 CKD stage 5 patients lasting up to 13 months in duration After a baseline or washout period ZEMPLAR IV was administered 2 to 3 times
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phosphorus and low active vitamin D levels trigger the parathyroid gland to continue releasing PTH into the blood Next
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New medicines Zemplar Composition Paricalcitol 5µg ml Presentation Solution for injection Class action Synthetic vitamin D analogue Indications Prevention and treatment of
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Calcium and phosphorus levels versus placebo 2 CKD stage 5 patients were studied in 3 identical double blind placebo controlled dose escalating randomized multicenter trials After a 4 week washout ZEMPLAR or placebo was
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Percent reduction in PTH levels from baseline over time 2 CKD stage 5 patients were studied in 3 identical double blind placebo controlled doseescalating randomized multicenter trials After a 4 week washout ZEMPLAR or placebo was
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The Early Decline of Calcitriol and the rise in PTH that Follows 1 A study designed to evaluate calcitriol and PTH values in 150 patients with various levels of chronic renal insufficiency Calcitriol normal values were defined as a range between 18
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Declining kidney function impairs the activation of vitamin D Increased PTH and decreased activated vitamin D are early indicators of CKD progression 1 As early as stage 3 CKD GFR <60 patients may have already lost up to 50 of their calcitriol levels before PTH even begins to rise 1
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67 mean PTH suppression by month 12 2 Of the 164 patients enrolled in this open label multi investigator long term study a subset analysis was conducted in 35 patients defined as hyperphosphatemic baseline P>7 mg dL
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No statistically significant difference from baseline in phosphorus or calcium levels after 16 months 1 Long term prospective open label study of CKD stage 5 patients resistant to intravenous calcitriol All patients underwent hemodialysis 3 times weekly and received nutritional
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