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

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).

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease (CKD); Secondary Hyperparathyroidism (SHPT)
• Intervention / Treatment: Drug: Paricalcitol

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Puerto Rico
  • San Juan, Puerto Rico, 00935
    • Recruiting
    • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663
    • Contact: Site Coordinator; Phone Number: 844-663-3742
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Completed
      • Arkansas Children's Hospital /ID# 225417
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • Stanford University /ID# 252150
  • District of Columbia
    • Washington, District of Columbia, United States, 20010-2916
      • Recruiting
      • Children's National Medical Center /ID# 225991
  • Florida
    • Miami, Florida, United States, 33136-1005
      • Recruiting
      • Holtz Childrens Hospital, University of Miami /ID# 225636
    • Miami, Florida, United States, 33155-3009
      • Completed
      • Nicklaus Children's Hospital /ID# 210517
  • Georgia
    • Atlanta, Georgia, United States, 30322-1014
      • Completed
      • Emory University /ID# 140665
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital /ID# 162863
  • North Carolina
    • Charlotte, North Carolina, United States, 28203-5866
      • Completed
      • Levine Children's Specialty Center- Charlotte /ID# 216057
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-4319
      • Recruiting
      • Children's Hospital of Philadelphia - Main /ID# 213802
  • Texas
    • Dallas, Texas, United States, 75390-7208
      • Recruiting
      • University of Texas Southwestern Medical Center /ID# 210495
  • Utah
    • Salt Lake City, Utah, United States, 84112-5500
      • Recruiting
      • University of Utah /ID# 140669
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital /ID# 162861

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 9 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Paricalcitol; Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieve Positive Response During Dosing Period 1	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).	Up to Week 12
Incidence of Hypercalcemia During Dosing Period 1	Incidence of hypercalcemia is defined as two consecutive, post-baseline, corrected calcium measurements above the normal participants's age-specific upper limit.	Up to Week 12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): October 30, 2026

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 20, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease; Hyperparathyroidism; Paricalcitol; Pediatric Subjects; Peritoneal Dialysis (PD); Hemodialysis (HD); Intact parathyroid hormone (iPTH)
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urologic Diseases; Endocrine System Diseases; Disease Attributes; Renal Insufficiency; Parathyroid Diseases; Neoplastic Processes; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Neoplasm Metastasis; Hyperparathyroidism, Secondary
• Other Study ID Numbers: M11-617

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes