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
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Study Details
Medical Condition
Study Drug
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
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