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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)
Sponsor: AbbVie
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).
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
Key Details
Gender
All
Age Range
0 Years - 9 Years
Study Type
INTERVENTIONAL
Enrollment
2
Start Date
2020-09-16
Completion Date
2025-06-09
Last Updated
2026-06-15
Healthy Volunteers
No
Interventions
Paricalcitol
Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
Locations (15)
Arkansas Children's Hospital /ID# 225417
Little Rock, Arkansas, United States
Stanford University School of Medicine - Redwood City /ID# 252150
Redwood City, California, United States
Childrens National Medical Center /ID# 225991
Washington D.C., 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
Augusta University Medical Center /ID# 252149
Augusta, Georgia, United States
Boston Children's Hospital /ID# 162863
Boston, Massachusetts, United States
Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057
Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Medical Center /ID# 266045
Winston-Salem, 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