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Not recruiting
Phase 3

Paricalcitol

Sponsor:

AbbVie

Code:

NCT04064827

Conditions

Chronic Kidney Disease (CKD)

Secondary Hyperparathyroidism (SHPT)

Eligibility Criteria

Sex: All

Age: 0 - 9

Healthy Volunteers: Not accepted

Interventions

Paricalcitol

Study Details

Brief 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).

Conditions

Chronic Kidney Disease (CKD)

Secondary Hyperparathyroidism (SHPT)

Study ID

NCT04064827

Start date

Sep 16, 2020

Status verified date

May, 2025

Completion date

Oct, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 9

Healthy Volunteers: Not accepted

Inclusion 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

16 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants Receiving Paricalcitol

Participants will be administered paricalcitol three times a week (TIW) but no more frequently than every other day for 24 weeks

Interventions

Paricalcitol

Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser

Primary outcome measure

  • Percentage of Participants Who Achieve Positive Response During Dosing Period 1 [ Time Frame: Up to Week 12 ]
  • Incidence of Hypercalcemia During Dosing Period 1 [ Time Frame: Up to Week 12 ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742abbvieclinicaltrials@abbvie.com

Locations

Stanford University /ID# 252150

Recruiting

Redwood City, California, United States, 94063

Children's National Medical Center /ID# 225991

Recruiting

Washington, District of Columbia, United States, 20010-2916

Holtz Childrens Hospital, University of Miami /ID# 225636

Recruiting

Miami, Florida, United States, 33136-1005

Augusta University Medical Center /ID# 252149

Recruiting

Augusta, Georgia, United States, 30912-0004

Boston Children's Hospital /ID# 162863

Recruiting

Boston, Massachusetts, United States, 02115

Wake Forest University Health Services /ID# 266045

Recruiting

Winston-Salem, North Carolina, United States, 27157-0001

Children's Hospital of Philadelphia - Main /ID# 213802

Recruiting

Philadelphia, Pennsylvania, United States, 19104-4319

University of Texas Southwestern Medical Center /ID# 210495

Recruiting

Dallas, Texas, United States, 75390-7208

University of Utah /ID# 140669

Recruiting

Salt Lake City, Utah, United States, 84112-5500

More Information

Sponsor

AbbVie

Last update posted

May 6, 2025

Last verified

May, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-17. This information was provided to ClinicalTrials.gov by AbbVie on 2025-05-06.