A Study to Evaluate the Safety of Paricalcitol Capsules in Pediatric Subjects Ages 10 to 16 With Stage 5 Chronic Kidney Disease Receiving Peritoneal Dialysis or Hemodialysis

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 26 subjects were screened and 13 pediatric subjects (between 10 and 16 years of age) were enrolled; 1 subject was 16 years of age at the time of Screening and turned 17 by the time treatment began.

Reporting Groups

	Description
Paricalcitol	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.

Participant Flow:   Overall Study

	Paricalcitol
STARTED	13
COMPLETED	11
NOT COMPLETED	2
Kidney transplant	1
Withdrew consent	1

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
Paricalcitol	Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.

Baseline Measures

	Paricalcitol
Overall Participants Analyzed  [Units: Participants]	13
Age  [Units: Years] Mean (Standard Deviation)	14.5  (1.76)
Gender  [Units: Participants] Count of Participants
Female	8  61.5%
Male	5  38.5%

1.  Primary:

Percentage of Subjects With Hypercalcemia   [ Time Frame: Day 1 to Week 12 ]

2.  Secondary:

Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Week 12 ]

3.  Secondary:

Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Week 12 ]

4.  Secondary:

Hemoglobin: Mean Change From Baseline to Final Visit   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ]

5.  Secondary:

Hematocrit: Mean Change From Baseline to Final Visit   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ]

6.  Secondary:

Red Blood Cells: Mean Change From Baseline to Final Visit   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ]

7.  Secondary:

White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ]

8.  Secondary:

Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ]

9.  Secondary:

Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ]

10.  Secondary:

Bilirubin, Blood Urea Nitrogen (BUN), Uric Acid, Magnesium, Glucose, Cholesterol, Triglycerides, High Sensitivity C-Reactive Protein (hsCRP), Inorganic Phosphate, Corrected Calcium, and Creatinine: Mean Change From Baseline to Final Visit   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ]

11.  Secondary:

Alkaline Phosphatase: Mean Change From Baseline to Final Visit   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ]

12.  Secondary:

Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ]

13.  Secondary:

Total Protein and Albumin: Mean Change From Baseline to Final Visit   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ]

14.  Secondary:

Fibroblast Growth Factor-23 (FGF-23), 1,25-Hydroxy Vitamin D, 25-Hydroxy Vitamin D, and Intact Parathyroid Hormone (iPTH): Mean Change From Baseline to Final Visit   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ]

15.  Secondary:

Osteocalcin: Mean Change From Baseline to Final Visit   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ]

16.  Secondary:

Number of Subjects With Adverse Events   [ Time Frame: From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks). ]

17.  Secondary:

Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings   [ Time Frame: Baseline (Day 1) to Final Visit (up to Week 12) ]

18.  Secondary:

Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ]

19.  Secondary:

Heart Rate: Mean Change From Baseline to Final Visit   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ]

20.  Secondary:

Oral Body Temperature: Mean Change From Baseline to Final Visit   [ Time Frame: Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12) ]

21.  Secondary:

Number of Subjects With Potentially Clinically Significant Physical Examination Findings   [ Time Frame: Baseline (Day 1) and Final Visit (up to Week 12) ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The sample size of the study was limited to 13 subjects and there was no comparator group, so the study was not designed to analyze efficacy.