Secondary Hyperparathyroidism-Chronic Kidney Disease Clinical Trial
Official title:
An Open-Label, Randomized, Parallel Group Study to Assess the Safety and Efficacy of Hectorol® (Doxercalciferol Capsules) in Pediatric Patients With Chronic Kidney Disease Stages 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Primary Objective: Evaluate the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: - Evaluate the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules. - Determine the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.
The total study duration per patient will be approximately up to 28 weeks. ;