Chronic Kidney Disease and Hyperparathyroidism Treatment with Hectorol – Phase III

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

Protocol Description

Through this study, researchers are evaluating Hectorol® (doxercalciferol), for treatment of children with chronic kidney disease and elevated parathyroid hormone. Hectorol is an inactive vitamin D2 that changes to an active vitamin D2 in the liver, which along with parathyroid hormone regulates overall calcium concentration in the blood. Chronic kidney dysfunction in children causes a decrease in serum calcium, which leads to high parathyroid hormone levels and ultimately a malfunction of their bones.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, this study is accepting participants, ages 5 through 17, who have Stage 3 or 4 chronic kidney disease and are not on dialysis, who also have hyperparathyroidism.
Males and Females: Ages 5 through 17 years


Participants will be randomly assigned to be given either Hectorol or Rocaltrol, an approved similar drug that is being used as a control compound in this study. Following the initial screening period, participants will take the assigned drug as an oral capsule, with the dose adjusted as needed every two weeks during a visit with the study doctor.
Visits: Up to 12
Duration: Up to 28 weeks

Status: Open to Enrollment

Source(s) of Support

Sanofi US Services

Primary Investigator

Michael Moritz, MD

Contact Information

For more information about the study or enrollment, please contact:
Dawn Thomas, RN, MSN, CPN