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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04064827

Enrollment

Registered

2019-08-22

Start date

2020-09-16

Completion date

2025-06-09

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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).

Interventions

DRUGParicalcitol

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

0 Years to 9 Years

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 \> 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.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants Who Achieve Positive Response During Dosing Period 1	Up to Week 12	Positive response is defined as having two consecutive \>= 30% reductions from baseline in intact parathyroid hormone (iPTH) or two consecutive iPTH values in the target range between 150 picograms (pg)/milliliters (mL) to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).
Incidence of Hypercalcemia During Dosing Period 1	Up to Week 12	Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.

Secondary

Measure	Time frame	Description
Percentage of Participants Who Achieve a Positive Response During Dosing Period 2	Week 12 through Week 24	Positive response is defined as having two consecutive \>= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).
Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined	Up to Week 24	Positive response is defined as having two consecutive \>= 30% reductions from baseline in iPTH or two consecutive iPTH values in the target range between 150 pg/mL to 300 pg/mL (16.5-33.0 picomole\[pmol\]/L).
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1	Up to Week 12	Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2	Week 12 through Week 24	Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined	Up to Week 24	Participants who achieve two consecutive \>= 30% reductions in iPTH will be evaluated.
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 1	Up to Week 12	Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Period 2	Week 12 through Week 24	Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
Percentage of Participants Who Achieve Two Consecutive iPTH Values Between 150 pg/mL to 300 pg/mL (16.5 - 33.0 Pmol/L) During Dosing Periods 1 and 2 Combined	Up to Week 24	Participants who achieve two consecutive iPTH values between 150 pg/mL to 300 pg/mL (16.5 - 33.0 pmol/L) will be evaluated.
Incidence of Hypercalcemia During Dosing Period 2	Week 12 through Week 24	Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.
Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined	Up to Week 24	Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.

Countries

Puerto Rico, United States

Contacts

STUDY_DIRECTORABBVIE INC.

AbbVie

Baseline characteristics

Characteristic	—
Age, Customized 2 to 9 years	2 Participants
Age, Customized < 2 years	0 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	2 Participants
Sex: Female, Male Female	1 Participants
Sex: Female, Male Male	1 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 2
other Total, other adverse events	1 / 2
serious Total, serious adverse events	2 / 2

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026