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)
NCT ID: NCT04064827
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
2 participants
INTERVENTIONAL
2020-09-16
2025-05-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Participants Receiving Paricalcitol
Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks
Paricalcitol
Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
Interventions
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Paricalcitol
Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
0 Years
9 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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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
Countries
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Related Links
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Other Identifiers
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M11-617
Identifier Type: -
Identifier Source: org_study_id