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TERMINATED
NCT04064827
PHASE3

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

View on ClinicalTrials.gov

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

DRUG

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