U:  P:        Forgot Password? Username?

Current Trials

Nephrology Anemia within Chronic Kidney Disease A Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric Subject
A Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric Subject PDF Print E-mail

The study consists of two parts. Part I is an open-label single-dose, non-fasting, multicenter study to evaluate the pharmacokinetics of paricalcitol capsules in 12 pediatric subjects ages 10 to 16 years with CKD Stages 3 and 4. Part II of this study will be conducted as a 12 week randomized double-blind, placebo-controlled study, followed by 12 weeks open-label treatment. The objective of this multicenter study is to evaluate the safety and efficacy of paricalcitol capsules in decreasing serum intact parathyroid hormone (iPTH) levels to K/DOQI target goals in 72 pediatric subjects ages 10 to 16 years with CKD Stages 3 and 4.