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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)

Description

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).

Conditions

Chronic Kidney Disease (CKD)Secondary Hyperparathyroidism (SHPT)
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Related Conditions:

Chronic Kidney Disease (CKD)Secondary Hyperparathyroidism (SHPT)

Study Overview

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Study Details

Study overview

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).

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

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)

Condition
Chronic Kidney Disease (CKD)
Intervention / Treatment

-

Contacts and Locations

Little Rock

Arkansas Children's Hospital /ID# 225417, Little Rock, Arkansas, United States, 72202

Redwood City

Stanford University /ID# 252150, Redwood City, California, United States, 94063

Washington

Children's National Medical Center /ID# 225991, Washington, District of Columbia, United States, 20010-2916

Miami

Holtz Childrens Hospital, University of Miami /ID# 225636, Miami, Florida, United States, 33136-1005

Miami

Nicklaus Children's Hospital /ID# 210517, Miami, Florida, United States, 33155-3009

Atlanta

Emory University /ID# 140665, Atlanta, Georgia, United States, 30322-1014

Boston

Boston Children's Hospital /ID# 162863, Boston, Massachusetts, United States, 02115

Charlotte

Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057, Charlotte, North Carolina, United States, 28203-5866

Philadelphia

Children's Hospital of Philadelphia - Main /ID# 213802, Philadelphia, Pennsylvania, United States, 19104-4319

Dallas

University of Texas Southwestern Medical Center /ID# 210495, Dallas, Texas, United States, 75390-7208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participant is currently diagnosed with and/or being treated for secondary hyperparathyroidism (SHPT).
  • * Participant must be diagnosed with chronic kidney disease (CKD) stage 5 receiving peritoneal dialysis (PD) or hemodialysis (HD) for at least 30 days prior to initial Screening.
  • * For entry into the Washout Period (for vitamin D receptor activator \[VDRA\] non-naive participants), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.
  • * For entry into the Dosing Period (for VDRA-naive participants or VDRA non-naive participants who have completed the Washout Period), the participant must meet the appropriate laboratory criteria based upon the participant's age as described in the protocol.
  • * Participant is scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant recipient.
  • * Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD) within 3 months of the initial Screening visit.
  • * Participant has had a parathyroidectomy within 12 weeks prior to Screening.
  • * Participant is taking maintenance calcitonin, bisphosphonates, glucocorticoids (in a dose equivalent to more than \> 0.16 mg/kg/day or 5 mg prednisone/day, whichever is lower), 4 weeks prior to Dosing.
  • * Participant is receiving calcimimetics at the time of Screening or is expected to initiate calcimimetics at any time throughout the study.
  • * Participant is unable to take oral medications.

Ages Eligible for Study

0 Years to 9 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AbbVie,

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

2026-10-30