Paricalcitol capsule is an oral formulation of paricalcitol injection, a vitamin D analog effective in the prevention and treatment of SHPT associated with chronic renal failure. Three doubleblind, placebo-controlled, multicenter studies were conducted to evaluate the safety and efficacy of paricalcitol capsule in CKD stage 5 subjects on hemodialysis (HD) or peritoneal dialysis (PD). After a 4-8 week washout period, 225 subjects (HD: 150, PD: 75) with iPTH≧300 pg/mL, serum Ca 8.0-10.5 mg/dL and Ca×P04<65 were randomized (1:1) and treated with paricalcitol capsule or placebo 3× weekly for 12 weeks. Initial doses were based on iPTH levels at baseline (initial mcg dose=iPTH/60). Subsequent dose adjustments of 2 mcg were based on the weekly Ca, Ca×P04, and iPTH results; dose increases occurred every 2 weeks and decreases once per week.
Overall, 95/105 (90%) of paricalcitol-treated subjects had 2 consecutive 30 decreases in iPTH compared to 7/108 (6%) of placebo subjects (p<0.001) (
In conclusion, paricalcitol capsule provides sustained reduction of PTH in HD and PD subjects with adverse event profile comparable to placebo. It may be particularly beneficial to PD patients in regular IV administration of paricalcitol is practical.
The present application claims priority to U.S. Provisional Application No. 60/527,582, filed on Dec. 5, 2003, hereby incorporated in its entirety by reference
Number | Date | Country | |
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60527582 | Dec 2003 | US |