clinical trial · NCT02859896
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Secondary Hyperparathyroidism-Chronic Kidney DiseaseDoxercalciferol (GZ427397)Calcitriol
brief summary
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®.
started
Jan 19, 2017
primary completion
Jun 11, 2025
completion
Jun 11, 2025
last updated
Jul 29, 2025
detailed description
The total study duration per patient will be approximately up to 28 weeks.
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol