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

AbbVie15 sites in 2 countries2 target enrollmentSeptember 16, 2020

ConditionsChronic Kidney Disease (CKD)Secondary Hyperparathyroidism (SHPT)

InterventionsParicalcitol

DrugsParicalcitol

Overview

Phase: Phase 3
Intervention: Paricalcitol
Conditions: Chronic Kidney Disease (CKD)
Sponsor: AbbVie
Enrollment: 2
Locations: 15
Primary Endpoint: Percentage of Participants Who Achieve Positive Response During Dosing Period 1
Status: Terminated
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

September 16, 2020

End Date

June 9, 2025

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AbbVie

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Participants Receiving Paricalcitol

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

Intervention: Paricalcitol

Outcomes

Primary Outcomes

Percentage of Participants Who Achieve Positive Response During Dosing Period 1

Time Frame: 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

Time Frame: 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 Outcomes

Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined(Up to Week 24)
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1(Up to Week 12)
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)
Percentage of Participants Who Achieve a Positive Response During Dosing Period 2(Week 12 through Week 24)
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2(Week 12 through Week 24)
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)
Incidence of Hypercalcemia During Dosing Period 2(Week 12 through Week 24)
Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined(Up to Week 24)
Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined(Up to Week 24)
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)