TERMINATED

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 Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2020-09-16
Study Completion:2025-05-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT04064827

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.

Ages Eligible for Study:0 Years to 9 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Participant is currently diagnosed with and/or being treated for secondary hyperparathyroidism (SHPT).
  2. * 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.
  3. * 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.
  4. * 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.
  1. * Participant is scheduled to receive a living donor kidney transplant within 3 months of Screening or is a kidney transplant recipient.
  2. * Participant is expected to discontinue peritoneal dialysis (PD) or hemodialysis (HD) within 3 months of the initial Screening visit.
  3. * Participant has had a parathyroidectomy within 12 weeks prior to Screening.
  4. * 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.
  5. * Participant is receiving calcimimetics at the time of Screening or is expected to initiate calcimimetics at any time throughout the study.
  6. * Participant is unable to take oral medications.

Contacts and Locations

Principal Investigator

ABBVIE INC.
STUDY_DIRECTOR
AbbVie

Study Locations (Sites)

Arkansas Children's Hospital /ID# 225417
Little Rock, Arkansas, 72202
United States
Stanford University School of Medicine - Redwood City /ID# 252150
Redwood City, California, 94063
United States
Childrens National Medical Center /ID# 225991
Washington D.C., District of Columbia, 20010-2916
United States
Holtz Childrens Hospital, University of Miami /ID# 225636
Miami, Florida, 33136-1005
United States
Nicklaus Children's Hospital /ID# 210517
Miami, Florida, 33155-3009
United States
Emory University /ID# 140665
Atlanta, Georgia, 30322-1014
United States
Augusta University Medical Center /ID# 252149
Augusta, Georgia, 30912-0004
United States
Boston Children's Hospital /ID# 162863
Boston, Massachusetts, 02115
United States
Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057
Charlotte, North Carolina, 28203-5866
United States
Atrium Health Wake Forest Baptist Medical Center /ID# 266045
Winston-Salem, North Carolina, 27157
United States
Children's Hospital of Philadelphia - Main /ID# 213802
Philadelphia, Pennsylvania, 19104-4319
United States
University of Texas Southwestern Medical Center /ID# 210495
Dallas, Texas, 75390-7208
United States
University of Utah /ID# 140669
Salt Lake City, Utah, 84112-5500
United States
Seattle Children's Hospital /ID# 162861
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: AbbVie

  • ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-09-16
Study Completion Date2025-05-16

Study Record Updates

Study Start Date2020-09-16
Study Completion Date2025-05-16

Terms related to this study

Keywords Provided by Researchers

  • Chronic Kidney Disease
  • Paricalcitol
  • Hyperparathyroidism
  • Pediatric Subjects
  • Peritoneal Dialysis (PD)
  • Hemodialysis (HD)
  • Intact parathyroid hormone (iPTH)

Additional Relevant MeSH Terms

  • Chronic Kidney Disease (CKD)
  • Secondary Hyperparathyroidism (SHPT)