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

• Status: Recruiting
• Trial end date: 2025-11-12

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®.

• Phase: Phase 3

Details

• Lead Sponsor: Sanofi
• Treatments: 1 alpha-hydroxyergocalciferol; Calcitriol; Ergocalciferols