Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis

Summary

Primary Objective: Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: * Evaluated the safety profile of Hectorol® capsules versus Rocaltrol® (calcitriol) capsules. * Determined the pharmacokinetic profile of 1,25-dihydroxyvitamin D2 after administration of Hectorol®.

Timeline

Start

2017-01-19

Primary completion

2025-06-11

Completion

2025-06-11

Outcome

Missed primary endpoint

Stopped: “The study was conducted to fulfill a post-marketing commitment (PMC).FDA acknowledged the fulfillment of this PMC.”

registry analysis (superiority test); Doxercalciferol (Hectorol®) vs Calcitriol (Rocaltrol®); Perecntage difference -52.9 (95% CI -99.90 to -5.98) NCT02859896 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Calcitriol	Small molecule	—	Oral
Subject	Doxercalciferol	Small molecule	—	Oral

Indications