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)

Phase 3TerminatedNCT04064827

AbbVie2 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Kidney Disease (CKD)Secondary Hyperparathyroidism (SHPT)

Interventions

Eligibility

Sex: ALLMin age: 0 YearsMax age: 9 Years

Medical Language ↔ Plain English

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

...and 5 more locations

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: Up to Week 12

Secondary Outcomes

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).

Time frame: Week 12 through Week 24

Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to Week 24