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)

NCT04064827 | Terminated Phase 3 FDA Drug

• 1 other identifier: M11-617
• Study Type: interventional
• Target: 2
• Locations: 2 countries
• Sites: 15

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)

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Percentage of Participants Who Achieve a Positive Response During Dosing Period 2

  Week 12 through Week 24

• 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 >= 30% Reductions in iPTH From Baseline During Dosing Period 2

  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

  Up to Week 24

Study Arms (1)

Participants Receiving Paricalcitol

EXPERIMENTAL

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

Drug: Paricalcitol

Interventions

Paricalcitol DRUG

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

Participants Receiving Paricalcitol

Eligibility Criteria

• Age: 0 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (15)

Arkansas Children's Hospital /ID# 225417

Little Rock, Arkansas, 72202, United States

Location

Stanford University School of Medicine - Redwood City /ID# 252150

Redwood City, California, 94063, United States

Location

Childrens National Medical Center /ID# 225991

Washington D.C., District of Columbia, 20010-2916, United States

Location

Holtz Childrens Hospital, University of Miami /ID# 225636

Miami, Florida, 33136-1005, United States

Location

Nicklaus Children's Hospital /ID# 210517

Miami, Florida, 33155-3009, United States

Location

Emory University /ID# 140665

Atlanta, Georgia, 30322-1014, United States

Location

Augusta University Medical Center /ID# 252149

Augusta, Georgia, 30912-0004, United States

Location

Boston Children's Hospital /ID# 162863

Boston, Massachusetts, 02115, United States

Location

Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057

Charlotte, North Carolina, 28203-5866, United States

Location

Atrium Health Wake Forest Baptist Medical Center /ID# 266045

Winston-Salem, North Carolina, 27157, United States

Location

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

Philadelphia, Pennsylvania, 19104-4319, United States

Location

University of Texas Southwestern Medical Center /ID# 210495

Dallas, Texas, 75390-7208, United States

Location

University of Utah /ID# 140669

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

Location

Seattle Children's Hospital /ID# 162861

Seattle, Washington, 98105, United States

Location

School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663

San Juan, 00935, Puerto Rico

Location

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary; Hyperparathyroidism

Interventions

paricalcitol

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Parathyroid Diseases; Endocrine System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: August 22, 2019
• Study Start: September 16, 2020
• Primary Completion: June 9, 2025
• Study Completion: June 9, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (14); PR (1)