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)

Stopped early · Phase 3

Conditions studied: Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)

In brief

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).

Key facts

Study ID

NCT04064827

Run by

AbbVie

People needed

2

Starts

2020-09-16

Expected to finish

2025-06-09

Last updated by the study team

2026-06-15

Who can join

Age: any, up to 9. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 > 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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