Pediatric Chronic Kidney Disease Safety and Efficacy
Study Details
The purpose of this study is to assess the safety and efficacy of adding cinacalcet to the current treatment of secondary hyperparathyroidism in children currently receiving dialysis compared to a treatment regimen that does not include cinacalcet.
Protocol Summary
To demonstrate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone level (iPTH) by ≥ 30%
Timeframe: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks
To demonstrate the efficacy of cinacalcet for lowering the plasma iPTH level to ≤ 300 pg/mL (31.8 pmol/L)
Timeframe: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks
To demonstrate the impact of cinacalcet on corrected total serum calcium level
Timeframe: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks
To demonstrate the impact of cinacalcet on serum phosphorus level
Timeframe: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks
To demonstrate the impact of cinacalcet on the calcium x phosphorus product (Ca x P)
Timeframe: From baseline to end of Efficacy Assessment Period, assessed up to 30 weeks
Evaluate number of participants with adverse events, and frequency of episodes of hypocalcemia
Timeframe: Throughout entire treatment period, up to 60 weeks
Measure change in height to assess overall growth velocity
Timeframe: From baseline to end of Efficacy Assessment at Week 30, and from Week 30 to end of entire treatment at Week 60
To measure the percent change in ionized calcium
Timeframe: From baseline to the end of Efficacy Assessment Period up to 30 weeks