Efficacy
91% of patients achieved two consecutive >30% reductions from baseline iPTH vs placebo (P<0.001)
Based upon three 24-week, double-blind, placebo-controlled, randomized, multicenter, phase 3 clinical studies in CKD stage 3 and 4 patients. Two studies used an identical 3x weekly dosing design, and one study used a once-daily dosing design (N=220). At each visit, change from baseline for subjects who had data at that time.
- 13% of the placebo-treated patients achieved two consecutive >30% iPTH reductions from baseline
- At week 9, a >30% mean reduction in iPTH was achieved and was sustained throughout the rest of the study
Calcium and phosphorus levels during study period
Based upon three 24-week, double-blind, placebo-controlled, randomized, multicenter, phase 3 clinical studies in CKD stage 3 and 4 patients. Two studies used an identical 3x weekly dosing design, and one study used a once-daily dosing design (N=220). At each visit, change from baseline for subjects who had data at that time.
- Zemplar (paricalcitol) Capsules-treated patients experienced no clinically significant changes in calcium or phosphorus levels over time (mean values)
- Mean calcium (9.3-9.5 mg/dL) and phosphorus (4.0-4.3 mg/dL) levels remained within normal range throughout study
- There were no treatment-related adverse events associated with hypercalcemia or hyperphosphatemia in the Zemplar Capsules-treated patients
Zemplar Capsules significantly reduced bone-specific alkaline phosphatase compared to placebo
Based upon three 24-week, double-blind, placebo-controlled, randomized, multicenter, phase 3 clinical studies in CKD stage 3 and 4 patients. Two studies used an identical 3x weekly dosing design, and one study used a once-daily dosing design (N=220). At each visit, change from baseline for subjects who had data at that time.
- 46% reduction in mean serum bone-specific alkaline phosphatase ( P<0.001)
Paricalcitol was specifically designed to reduce PTH. Patient monitoring and individualized dose titration are required to maintain physiologic targets and optimum reduction/levels of PTH
