A Study to Evaluate Safety, Efficacy and Pharmacokinetics of Paricalcitol For Treatment of Secondary Hyperparathyroidism (SHPT) in Pediatric Participants With Stage 5 Chronic Kidney Disease (CKD)

Study Identifier
M11-617
CT.gov Identifier
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

Study Details

Medical Condition
  • Kidney Disease
  • Secondary Hyperparathyroidism
  • Study Drug
  • Paricalcitol
  • Phase
    Phase 3
    Sex
    Female & Male
    Age
    0 - 9 Years

    Protocol Summary

    The main objective of this study is to evaluate the safety, efficacy and pharmacokinetics of paricalcitol oral solution in pediatric participants of ages 0 to 9 years with SHPT associated with stage 5 CKD receiving Peritoneal Dialysis (PD) or Hemodialysis (HD). The 24-week study is divided into two 12-week dosing periods (Dosing Period 1 followed by Dosing Period 2).

    Study Locations

    Location
    Status
    Location
    Arkansas Children's Hospital /ID# 225417
    Little Rock, Arkansas, United States, 72202
    Status
    Not applicable
    Location
    Stanford University School of Medicine - Redwood City /ID# 252150
    Redwood City, California, United States, 94063
    Status
    Not applicable
    Location
    Childrens National Medical Center /ID# 225991
    Washington D.C., District of Columbia, United States, 20010-2916
    Status
    Not applicable
    Location
    Holtz Childrens Hospital, University of Miami /ID# 225636
    Miami, Florida, United States, 33136-1005
    Status
    Not applicable
    Location
    Nicklaus Children's Hospital /ID# 210517
    Miami, Florida, United States, 33155-3009
    Status
    Not applicable
    Location
    Emory University /ID# 140665
    Atlanta, Georgia, United States, 30322-1014
    Status
    Not applicable
    Showing {first} - {last} of {total} Results