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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01382212
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : November 21, 2016
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions End-Stage Renal Disease
Secondary Hyperparathyroidism
Intervention Drug: paricalcitol
Enrollment 13
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Paricalcitol
Hide Arm/Group Description Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Period Title: Overall Study
Started 13
Completed 11
Not Completed 2
Reason Not Completed
Kidney transplant             1
Withdrew consent             1
Arm/Group Title Paricalcitol
Hide Arm/Group Description Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants
14.5  (1.76)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
8
  61.5%
Male
5
  38.5%
1.Primary Outcome
Title Percentage of Subjects With Hypercalcemia
Hide Description The percentage of subjects with hypercalcemia, defined as at least 2 consecutive post-baseline corrected calcium values > 10.2 mg/dL (2.55 mmol/L).
Time Frame Day 1 to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All-treated data set: all subjects enrolled and administered at least 1 dose of paricalcitol
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.3
(1.9 to 45.4)
2.Secondary Outcome
Title Percentage of Subjects With 2 Consecutive Intact Parathyroid Hormone (iPTH)/120 Between 150 and 300 pg/mL
Hide Description [Not Specified]
Time Frame Baseline (last measurement collected prior to the first dose) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All-treated data set
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.5
(13.9 to 68.4)
3.Secondary Outcome
Title Percentage of Subjects With 2 Consecutive iPTH Reductions of at Least 30% From Baseline
Hide Description [Not Specified]
Time Frame Baseline (last measurement collected prior to the first dose) to Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
All-treated data set
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
61.5
(31.6 to 86.1)
4.Secondary Outcome
Title Hemoglobin: Mean Change From Baseline to Final Visit
Hide Description [Not Specified]
Time Frame Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the all-treated data set with evaluable data
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: g/dL
-0.1  (1.263)
5.Secondary Outcome
Title Hematocrit: Mean Change From Baseline to Final Visit
Hide Description [Not Specified]
Time Frame Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the all-treated data set with evaluable data
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: percent
-1.08  (5.066)
6.Secondary Outcome
Title Red Blood Cells: Mean Change From Baseline to Final Visit
Hide Description [Not Specified]
Time Frame Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the all-treated data set with evaluable data
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: cells x 10^6/µL
-0.09  (0.496)
7.Secondary Outcome
Title White Blood Cells (WBC) and Platelet Count: Mean Change From Baseline to Final Visit
Hide Description [Not Specified]
Time Frame Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the all-treated data set with evaluable data
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: cells x 10^3/µL
WBC -0.06  (2.982)
Platelet Count 19.2  (47.03)
8.Secondary Outcome
Title Neutrophils, Lymphocytes, Monocytes, Eosinophils, and Basophils: Mean Change From Baseline to Final Visit
Hide Description [Not Specified]
Time Frame Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the all-treated data set with evaluable data
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: cells x 10^9/µL
Neutrophils 0.11  (2.6812)
Lymphocytes -0.294  (0.597)
Monocytes 0.032  (0.1276)
Eosinophils 0.059  (0.1522)
Basophils -0.01  (0.0322)
9.Secondary Outcome
Title Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactic Dehydrogenase (LDH), and Bone-Specific Alkaline Phosphatase (BSAP): Mean Change From Baseline to Final Visit
Hide Description n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Time Frame Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the all-treated data set with evaluable data
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: U/L
ALT (n=11) -4.55  (16.501)
AST (n=11) -4.45  (12.25)
LDH (n=11) -6.5  (33.22)
BSAP (n=9) -49.4  (86.95)
10.Secondary Outcome
Title 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
Hide Description n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Time Frame Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the all-treated data set with evaluable data
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mg/dL
Total bilirubin (n=11) 0.032  (0.3165)
Direct Bilirubin (n=11) 0.013  (0.0785)
Indirect Bilirubin (n=9) 0.056  (0.3035)
BUN (n=11) 1.33  (11.614)
Uric Acid (n=11) 0.31  (1.245)
Magnesium (n=11) 0.082  (0.3649)
Glucose (n=11) 4.36  (10.172)
Cholesterol (n=11) -16.4  (27.37)
Triglycerides (n=11) 9.2  (40.32)
hsCRP (n=11) 0.061  (0.1967)
Inorganic phosphate (n=13) 0.64  (1.188)
Corrected Calcium (n=7) 0.31  (0.421)
Creatinine (n=11) 0.48  (1.592)
11.Secondary Outcome
Title Alkaline Phosphatase: Mean Change From Baseline to Final Visit
Hide Description [Not Specified]
Time Frame Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the all-treated data set with evaluable data
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: IU/L
-61.8  (117.34)
12.Secondary Outcome
Title Sodium, Potassium, Chloride, Bicarbonate: Mean Change From Baseline to Final Visit
Hide Description [Not Specified]
Time Frame Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the all-treated data set with evaluable data
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 11
Mean (Standard Deviation)
Unit of Measure: mEq/L
Sodium -0.5  (2.02)
Potassium 0.25  (0.746)
Chloride 0.5  (3.21)
Bicarbonate -0.45  (3.446)
13.Secondary Outcome
Title Total Protein and Albumin: Mean Change From Baseline to Final Visit
Hide Description n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Time Frame Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All-treated data set
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: g/dL
Total protein (n=11) 0.15  (0.43)
Albumin (n=13) 0.04  (0.325)
14.Secondary Outcome
Title 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
Hide Description n=subjects with evaluable Baseline and Post-baseline data for each parameter.
Time Frame Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All-treated data set
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: pg/mL
FGF-23 (n=10) 1990.7  (3317.7)
1,25-Hydroxy Vitamin D (n=11) 15.65  (29.296)
25-Hydroxy Vitamin D (n=11) 5.8  (10.38)
iPTH (n=13) -437.5  (491.83)
15.Secondary Outcome
Title Osteocalcin: Mean Change From Baseline to Final Visit
Hide Description [Not Specified]
Time Frame Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects in the all-treated data set with evaluable data
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
117.21  (223.07)
16.Secondary Outcome
Title Number of Subjects With Adverse Events
Hide Description An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section.
Time Frame From first dose of study drug until 30 days following last dose of study drug (up to 16 weeks).
Hide Outcome Measure Data
Hide Analysis Population Description
All-treated data set
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
Any TEAE 11
TESAE 2
17.Secondary Outcome
Title Number of Subjects With Potentially Clinically Significant Electrocardiogram (ECG) Findings
Hide Description 12-lead ECGs were recorded after the subject had been in the supine position for at least 5 minutes. The number of subjects with potentially clinically significant ECG findings, as determined by the investigator, is presented.
Time Frame Baseline (Day 1) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All-treated data set
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
0
18.Secondary Outcome
Title Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP): Mean Change From Baseline to Final Visit
Hide Description Blood pressure was measured after the subject had been sitting for at least 3 minutes.
Time Frame Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All-treated data set
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: mm Hg
SBP 7.5  (15.66)
DBP 3.7  (12.98)
19.Secondary Outcome
Title Heart Rate: Mean Change From Baseline to Final Visit
Hide Description Heart rate was measured after the subject had been sitting for at least 3 minutes.
Time Frame Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All-treated data set
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: bpm
1.8  (17.43)
20.Secondary Outcome
Title Oral Body Temperature: Mean Change From Baseline to Final Visit
Hide Description [Not Specified]
Time Frame Baseline (last measurement collected prior to the first dose) to Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All-treated data set
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 13
Mean (Standard Deviation)
Unit of Measure: degrees Celsius
0.03  (0.338)
21.Secondary Outcome
Title Number of Subjects With Potentially Clinically Significant Physical Examination Findings
Hide Description [Not Specified]
Time Frame Baseline (Day 1) and Final Visit (up to Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
All-treated data set
Arm/Group Title Paricalcitol
Hide Arm/Group Description:
Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
0
Time Frame Treatment-emergent adverse events were collected from first dose of study drug until 30 days following last dose of study drug (up to 16 weeks); serious adverse events were collected from the time when informed consent was obtained (up to 28 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Paricalcitol
Hide Arm/Group Description Open-label paricalcitol (maximum dose of 16 μg), 3 times weekly (no more frequently than every other day) for 12 weeks.
All-Cause Mortality
Paricalcitol
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Paricalcitol
Affected / at Risk (%)
Total   2/13 (15.38%) 
Injury, poisoning and procedural complications   
PERITONEAL DIALYSIS COMPLICATION † 1  1/13 (7.69%) 
Metabolism and nutrition disorders   
FLUID OVERLOAD † 1  1/13 (7.69%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Paricalcitol
Affected / at Risk (%)
Total   10/13 (76.92%) 
Gastrointestinal disorders   
ABDOMINAL PAIN † 1  1/13 (7.69%) 
ABDOMINAL PAIN UPPER † 1  1/13 (7.69%) 
DIARRHOEA † 1  1/13 (7.69%) 
NAUSEA † 1  2/13 (15.38%) 
VOMITING † 1  1/13 (7.69%) 
General disorders   
INFLUENZA LIKE ILLNESS † 1  1/13 (7.69%) 
PYREXIA † 1  2/13 (15.38%) 
Infections and infestations   
UPPER RESPIRATORY TRACT INFECTION † 1  1/13 (7.69%) 
Injury, poisoning and procedural complications   
ARTERIOVENOUS FISTULA SITE COMPLICATION † 1  1/13 (7.69%) 
PROCEDURAL PAIN † 1  1/13 (7.69%) 
PROCEDURAL VOMITING † 1  1/13 (7.69%) 
Investigations   
BLOOD CALCIUM INCREASED † 1  1/13 (7.69%) 
HAEMOGLOBIN DECREASED † 1  1/13 (7.69%) 
Metabolism and nutrition disorders   
HYPERPHOSPHATAEMIA † 1  1/13 (7.69%) 
Musculoskeletal and connective tissue disorders   
BACK PAIN † 1  1/13 (7.69%) 
PAIN IN EXTREMITY † 1  1/13 (7.69%) 
Nervous system disorders   
HEADACHE † 1  1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders   
COUGH † 1  2/13 (15.38%) 
THROAT IRRITATION † 1  1/13 (7.69%) 
Skin and subcutaneous tissue disorders   
PRURITUS † 1  1/13 (7.69%) 
Vascular disorders   
HYPERTENSION † 1  1/13 (7.69%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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.
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.
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Medical Information
Organization: AbbVie
Phone: 800-633-9110
Publications of Results:
Webb NJA, Lerner G, Warady BA, Dell KM, Greenbaum LA, Ariceta G, Hoppe B, Linde P, Lee HJ, Eldred A, Dufek MB. Efficacy and safety of paricalcitol in children with stages 3 to 5 chronic kidney disease. Pediatr Nephrol. 2017 Jul;32(7):1221-1232. doi: 10.1007/s00467-017-3579-6. Epub 2017 Mar 22.
Layout table for additonal information
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01382212    
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: July 2, 2018