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Nephrology
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.
 
A Prospective, Multicenter Study to Evaluate the PDF Print E-mail

The objective of this study is to observe the safety of paricalcitol utilization in pediatric

patients being treated for secondary hyperparathyroidism (SHPT). Patients will be

followed for a minimum of 3 months and up to approximately 36 months to monitor the

incidence of hypercalcemia. The safety will be primarily measured by the proportion of

patients developing at least one episode of hypercalcemia (calcium > 10.2 mg/dL). We

will also measure incident rates of adverse events and serious adverse events, and the

change from baseline in laboratory assessments, height and weight
 
Study to Assess Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Subjects With CKD PDF Print E-mail
  • A Multi-Center, Double-Blind, Randomized Study Evaluating De Novo Weekly and Once Every Two Week Darbepoetin Alfa Dosing for the Correction of Anemia in Pediatric Subjects With Chronic Kidney Disease Receiving and Not Receiving Dialysis

 

 
 


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