Extension Study of Cinacalcet for Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Patients With Chronic Kidney Disease on Dialysis
Study Details
The primary objective of this study was to characterize the long-term safety and tolerability of cinacalcet in pediatric patients with chronic kidney disease (CKD) receiving dialysis.
Protocol Summary
Incidence of treatment-emergent adverse events of interest
Timeframe: between day 1 and up to 30 days after last IP dose
Changes in intact parathyroid hormone (iPTH)
Timeframe: From baseline to Week 15
Changes in intact parathyroid hormone (iPTH)
Timeframe: From baseline to Week 28
Changes in intact parathyroid hormone (iPTH)
Timeframe: From baseline to Week 28
Changes in corrected total serum calcium
Timeframe: From baseline to Week 28
Changes in serum phosphorus
Timeframe: From baseline to Week 28
Changes in intact parathyroid hormone (iPTH)
Timeframe: Week 23 to week 28
Changes in serum corrected calcium (cCa)
Timeframe: From baseline to week 28
Changes in serum phosphorus
Timeframe: From baseline to week 28
Changes in intact parathyroid hormone (iPTH)
Timeframe: From baseline to week 15
Changes in intact parathyroid hormone (iPTH)
Timeframe: From baseline to week 28
Changes in intact parathyroid hormone (iPTH)
Timeframe: From baseline to Week 28/End of Investigational Product
Changes in serum corrected calcium
Timeframe: From baseline to Week 28/End of Investigational Product
Changes in serum phosphorus
Timeframe: From baseline to Week 28/End of Investigational Product