Study to Assess the Safety and Efficacy of Hectorol® (doxercalciferol capsules) in Pediatric Patient

Trial Name

Study to Assess the Safety and Efficacy of Hectorol®(doxercalciferol capsules) in Pediatric Patient

What is the trial about?

The purpose of this study is to evaluate the possible risks and the effectiveness of an experimental study drug called Hectorol®, in patient’s ages 5 – 18 years old. Hectorol® is an inactive vitamin D2 that changes to an active vitamin D2 in the liver. Along with a hormone called "parathyroid hormone", it regulates the overall calcium concentration in the blood. In order to evaluate the possible risks and effectiveness of Hectorol®, a drug called Rocaltrol® will be used as a control compound in this study.

Who can participate?

Children that have been diagnosed with Chronic Kidney Disease (stage 3 or 4) and who are between the ages of 5-18 years of age may be able to participate in the study.

What is involved?

• Screening (for participants without washout): If you and your child agree to be in this study, you will be asked to sign a parental permission form before any study procedures are done.
• Screening Visit 1A/1B (for participants with washout) - The visit dates will depend on whether your child is taking cinacalcet or Vitamin D sterol therapies such as calciferol, doxercalciferol or paricalcitol. If your child is taking any of those medications, s/he will need to stop 14 days prior to the screening visit. If your child is taking one of these medications, s/he will need to stop the medications at the screening visit (Visit 1a) and a wash-out period, during which the effects of these medications leave your child’s body, of at least 2 weeks is required before the next screening visit (Visit 1b) can take place.
• Visit 2 (after screening day or visit 1b): Your child will be randomized to receive either Hectorol® or Rocaltrol® and will receive the first dosing of the drug.
• Visit 3 to visit 8 (during treatment period): Your child will have study visits every couple of weeks for the next 10 weeks.
• Safety Follow-up Visits: This will happen after your child stops taking Study Drug to check your child’s health. The visits will occur during visit 9, during week 18, and at visit 10 during week 24. The study doctor or study coordinator will let you and your child know if this visit is required.
• Early Termination Visit (ETT): If your child discontinues the Study Drug treatment early, you may be asked to bring your child in to complete this visit to check your child’s health.