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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

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ClinicalTrials.gov Identifier: NCT01382212
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : November 21, 2016
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: End-Stage Renal Disease
Secondary Hyperparathyroidism
Intervention: Drug: paricalcitol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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 



  Baseline Characteristics

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% 


  Outcome Measures

1.  Primary:   Percentage of Subjects With Hypercalcemia   [ Time Frame: Day 1 to Week 12 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

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 ]
  Show Outcome Measure 3

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) ]
  Show Outcome Measure 4

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) ]
  Show Outcome Measure 5

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) ]
  Show Outcome Measure 6

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) ]
  Show Outcome Measure 7

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) ]
  Show Outcome Measure 8

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) ]
  Show Outcome Measure 9

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) ]
  Show Outcome Measure 10

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) ]
  Show Outcome Measure 11

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) ]
  Show Outcome Measure 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) ]
  Show Outcome Measure 13

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) ]
  Show Outcome Measure 14

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) ]
  Show Outcome Measure 15

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). ]
  Show Outcome Measure 16

17.  Secondary:   Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings   [ Time Frame: Baseline (Day 1) to Final Visit (up to Week 12) ]
  Show Outcome Measure 17

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) ]
  Show Outcome Measure 18

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) ]
  Show Outcome Measure 19

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) ]
  Show Outcome Measure 20

21.  Secondary:   Number of Subjects With Potentially Clinically Significant Physical Examination Findings   [ Time Frame: Baseline (Day 1) and Final Visit (up to Week 12) ]
  Show Outcome Measure 21


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Medical Information
Organization: AbbVie
phone: 800-633-9110



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01382212     History of Changes
Other Study ID Numbers: M11-612
2013-002610-13 ( EudraCT Number )
First Submitted: June 24, 2011
First Posted: June 27, 2011
Results First Submitted: September 16, 2016
Results First Posted: November 21, 2016
Last Update Posted: November 21, 2016