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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.
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
Sanofi US Services
Study Description at National Institutes of Health
Chronic Kidney Disease
Michael Moritz, MD
For more information about the study or enrollment, please contact:
Dawn Thomas, RN, MSN, CPN
Children's Hospital's main campus is located in the Lawrenceville neighborhood. Our main hospital address is:
UPMC Children’s Hospital of Pittsburgh
One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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