Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD)

Study Identifier
M10-149
CT.gov Identifier
EudraCT Identifier
EUCTIS ID
Not available
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Results Available

Scientific Result Summary
Available Language(s): English

Study Details

Medical Condition
  • Kidney Disease
  • Study Drug
  • Paricalcitol
  • Placebo
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    10 - 16 Years

    Protocol Summary

    Part 1: To determine the safety, tolerability, and pharmacokinetics of a single dose of 3 μg paricalcitol capsules in children ages 10 to 16 years with moderate to severe chronic kidney disease (CKD Stages 3 and 4).

    Part 2: To determine the safety and efficacy of paricalcitol capsules as compared to placebo in decreasing serum intact parathyroid hormone (iPTH) in children ages 10 to 16 years with moderate to severe chronic kidney disease with an initial 12 weeks of double-blinded study drug followed by a minimum of 12 weeks of open-label active drug.

    Study Locations

    No locations found.