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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) | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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)

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

NCT04064827•AbbVie

View on ClinicalTrials.gov

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).

Eligibility

Age

0 - 9 years

Sex

ALL

Healthy Volunteers

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.

Locations (15)

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

Key Dates

Start Date

September 16, 2020

Primary Completion Date

June 9, 2025

Completion Date

June 9, 2025

Last Updated

December 4, 2025

Enrollment

ACTUAL participants

Conditions

Chronic Kidney Disease (CKD)Secondary Hyperparathyroidism (SHPT)

Interventions

Paricalcitol

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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)

Inclusion Criteria

Exclusion Criteria

A Prospective Clinical Evaluation of the Total Vascular Access (TVA) FLEX-1 Device Protocol FLEX-1-001

Domperidone and the Risk of Serious Adverse Events

Comparative Assessment of Efficacy & Safety of Sacubitril/Valsartan Versus Ramipril in Patients With Renal Dysfunction Hospitalized With Acute Decompensated Heart Failure

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