Clinical trial NCT04064827: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
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)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2019-08-22
Enrollment: 16
Sex: ALL
Minimum age (years): 0
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


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.

Primary outcomes:
measure: Percentage of Participants Who Achieve Positive Response During Dosing Period 1
timeFrame: Up to Week 12
measure: Incidence of Hypercalcemia During Dosing Period 1
timeFrame: Up to Week 12
Secondary outcomes:
measure: Percentage of Participants Who Achieve a Positive Response During Dosing Period 2
timeFrame: Week 12 through Week 24
measure: Percentage of Participants Who Achieve a Positive Response During Dosing Periods 1 and 2 Combined
timeFrame: Up to Week 24
measure: Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 1
timeFrame: Up to Week 12
measure: Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Period 2
timeFrame: Week 12 through Week 24
measure: Percentage of Participants Who Achieve Two Consecutive >= 30% Reductions in iPTH From Baseline During Dosing Periods 1 and 2 Combined
timeFrame: Up to Week 24
measure: 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
timeFrame: Up to Week 12
measure: 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
timeFrame: Week 12 through Week 24
measure: 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
timeFrame: Up to Week 24
measure: Incidence of Hypercalcemia During Dosing Period 2
timeFrame: Week 12 through Week 24
measure: Incidence of Hypercalcemia During Dosing Periods 1 and 2 Combined
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital /ID# 225417
state: Arkansas
city: Redwood City
country: United States
facility: Stanford University /ID# 252150
state: California
city: Washington
country: United States
facility: Children's National Medical Center /ID# 225991
state: District of Columbia
city: Miami
country: United States
facility: Holtz Childrens Hospital, University of Miami /ID# 225636
state: Florida
city: Miami
country: United States
facility: Nicklaus Children's Hospital /ID# 210517
state: Florida
city: Atlanta
country: United States
facility: Emory University /ID# 140665
state: Georgia
city: Augusta
country: United States
facility: Augusta University Medical Center /ID# 252149
state: Georgia
city: Boston
country: United States
facility: Boston Children's Hospital /ID# 162863
state: Massachusetts
city: Charlotte
country: United States
facility: Duplicate_Levine Children's Specialty Center- Charlotte /ID# 216057
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Services /ID# 266045
state: North Carolina
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia - Main /ID# 213802
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center /ID# 210495
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah /ID# 140669
state: Utah
city: Seattle
country: United States
facility: Seattle Children's Hospital /ID# 162861
state: Washington
city: San Juan
country: Puerto Rico
facility: School of Medicine University of Puerto Rico-Medical Science Campus /ID# 140663
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: