Spots Global Cancer Trial Database for 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)
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Trial Identification
Brief Title: 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)
Official Title: A Phase 3, Prospective, Open-Label, Multicenter Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Paricalcitol Oral Solution for the Treatment of Secondary Hyperparathyroidism in Pediatric Subjects Ages 0 to 9 Years With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis
Study ID: NCT04064827
Interventions
Study Description
Brief 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).
Detailed Description:
Eligibility
Minimum Age: 0 Years
Eligible Ages: CHILD
Sex: ALL
Healthy Volunteers: No
Locations
Arkansas Children's Hospital /ID# 225417, Little Rock, Arkansas, United States
Stanford University /ID# 252150, Redwood City, California, United States
Children's National Medical Center /ID# 225991, Washington, District of Columbia, United States
Holtz Childrens Hospital, University of Miami /ID# 225636, Miami, Florida, United States
Nicklaus Children's Hospital /ID# 210517, Miami, Florida, United States
Emory University /ID# 140665, Atlanta, Georgia, United States
Boston Children's Hospital /ID# 162863, Boston, Massachusetts, United States
Levine Children's Specialty Center- Charlotte /ID# 216057, Charlotte, North Carolina, United States
Children's Hospital of Philadelphia - Main /ID# 213802, Philadelphia, Pennsylvania, United States
University of Texas Southwestern Medical Center /ID# 210495, Dallas, Texas, United States
University of Utah /ID# 140669, Salt Lake City, Utah, United States
Seattle Children's Hospital /ID# 162861, Seattle, Washington, United States
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663, San Juan, , Puerto Rico
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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