ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD)

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: NCT01020487
Recruitment Status : Completed
First Posted : November 24, 2009
Results First Posted : March 29, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Kidney Disease Stage 3 and 4
Interventions Drug: Paricalcitol
Drug: Placebo
Enrollment 47
Recruitment Details Part 1 was an open-label, single-dose study evaluating the pharmacokinetics of paricalcitol capsules in children with moderate to severe chronic kidney disease (CKD). Part 2 consisted of a double-blind, placebo-controlled study to evaluate safety and efficacy of paricalcitol and an open-label phase where all participants received paricalcitol.
Pre-assignment Details Two participants enrolled in Part 2 after completing Part 1 of the study, hence the actual total number of enrolled participants is equal to 47.
Arm/Group Title Part 1: Paricalcitol Part 2: Placebo Part 2: Paricalcitol
Hide Arm/Group Description Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels. Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Period Title: Part 1
Started 12 0 0
Completed 12 0 0
Not Completed 0 0 0
Period Title: Part 2 Double-blind Treatment Period
Started 0 18 [1] 19 [1]
Received Treatment 0 18 18
Completed 0 16 13
Not Completed 0 2 6
Reason Not Completed
Adverse Event             0             2             1
Withdrawal by Subject             0             0             1
Required a Dose Reduction             0             0             3
Randomized in Error             0             0             1
[1]
Includes one participant who enrolled in Part 2 after completing Part 1
Period Title: Part 2 Open-label Period
Started 0 16 13
Completed 0 12 12
Not Completed 0 4 1
Reason Not Completed
Adverse Event             0             4             1
Arm/Group Title Part 1: Paricalcitol Part 2: Placebo Part 2: Paricalcitol Total
Hide Arm/Group Description Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels. Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels. Total of all reporting groups
Overall Number of Baseline Participants 12 18 19 49
Hide Baseline Analysis Population Description
All enrolled participants. Note: Two participants enrolled in Part 2 after completing Part 1 of the study, hence the actual total number of enrolled participants was 47. These 2 participants are counted in both arms they enrolled in for Baseline Measure data and are hence double-counted in the Total column for gender, race and CKD stage.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Part 1 Number Analyzed 12 participants 0 participants 0 participants 12 participants
13.5  (1.98) 13.5  (1.98)
Part 2 Number Analyzed 0 participants 18 participants 19 participants 37 participants
13.3  (1.75) 13.9  (1.81) 13.6  (1.78)
[1]
Measure Analysis Population Description: Baseline measure data were analyzed separately for participants in Part 1 and Part 2.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 18 participants 19 participants 49 participants
Female
3
  25.0%
5
  27.8%
6
  31.6%
14
  28.6%
Male
9
  75.0%
13
  72.2%
13
  68.4%
35
  71.4%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 18 participants 19 participants 49 participants
White
10
  83.3%
17
  94.4%
14
  73.7%
41
  83.7%
Black
1
   8.3%
0
   0.0%
0
   0.0%
1
   2.0%
Asian
0
   0.0%
0
   0.0%
4
  21.1%
4
   8.2%
American Indian/Alaska Native
1
   8.3%
0
   0.0%
0
   0.0%
1
   2.0%
Native Hawaiian or other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Other
0
   0.0%
1
   5.6%
1
   5.3%
2
   4.1%
Chronic Kidney Disease Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 18 participants 19 participants 49 participants
Stage 3
6
  50.0%
11
  61.1%
10
  52.6%
27
  55.1%
Stage 4
6
  50.0%
7
  38.9%
8
  42.1%
21
  42.9%
Missing
0
   0.0%
0
   0.0%
1
   5.3%
1
   2.0%
[1]
Measure Description: Stage 3: estimated glomerular filtration rate (eGFR) 30 to 59 mL/min/1.73 m²; Stage 4: eGFR 15 to 29 mL/min/1.73 m², not requiring dialysis
1.Primary Outcome
Title Part 1: Paricalcitol Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled and administered paricalcitol for the pharmacokinetic (PK) period, Part 1
Arm/Group Title Part 1: Paricalcitol
Hide Arm/Group Description:
Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng/mL
0.13  (0.052)
2.Primary Outcome
Title Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
Hide Description [Not Specified]
Time Frame Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing.
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants enrolled and administered paricalcitol for the PK Portion, Part 1
Arm/Group Title Part 1: Paricalcitol
Hide Arm/Group Description:
Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: ng*hr/mL
2.87  (0.84)
3.Primary Outcome
Title Part 2: Percentage of Participants Achieving Two Consecutive Reductions at Least 30% From Baseline in iPTH
Hide Description The primary efficacy endpoint was the percentage of participants who achieved two consecutive ≥ 30% reductions from baseline in intact parathyroid hormone (iPTH) levels during the 12 week double-blind portion of the study regardless of CKD stage.
Time Frame 12-week double-blind treatment period
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The Intent-To-Treat (ITT) Dataset, defined as the set of all randomized participants who took at least one dose of study drug.
Arm/Group Title Part 2: Placebo Part 2: Paricalcitol
Hide Arm/Group Description:
Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: percentage of participants
0 27.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: Paricalcitol
Comments Treatment effects were evaluated based on a two-sided significance level of 0.050. The primary efficacy analysis was a comparison between the paricalcitol capsules and placebo groups in the percentage of participants achieving 2 consecutive ≥ 30% reductions in iPTH from baseline regardless of CKD stage conducted using Fisher's exact test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.045
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 27.8
Confidence Interval (2-Sided) 95%
7.5 to 52.8
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Part 2: Percentage of Participants Achieving a Final iPTH Within KDOQI Target Ranges
Hide Description

The Kidney Disease Outcomes Quality Initiatives (KDOQI) Pediatric Subcommittee on Practice Guidelines for Bone Metabolism and Disease in Children with CKD target range for intact parathyroid hormone (iPTH) is as follows::

CKD Stage 3: 35 – 69 pg/mL; CKD Stage 4: 70 – 110 pg/mL.

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat dataset
Arm/Group Title Part 2: Placebo Part 2: Paricalcitol
Hide Arm/Group Description:
Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: percentage of participants
11.1 33.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: Paricalcitol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.128
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.
5.Secondary Outcome
Title Part 2: Change From Baseline in iPTH to Each Post-baseline Visit
Hide Description [Not Specified]
Time Frame Baseline and Weeks 2, 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat dataset with available data at each time point
Arm/Group Title Part 2: Placebo Part 2: Paricalcitol
Hide Arm/Group Description:
Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Overall Number of Participants Analyzed 18 18
Least Squares Mean (Standard Error)
Unit of Measure: pg/mL
Week 2 Number Analyzed 15 participants 16 participants
50.39  (15.186) -12.16  (14.695)
Week 4 Number Analyzed 18 participants 16 participants
57.16  (20.813) -11.27  (22.117)
Week 8 Number Analyzed 18 participants 13 participants
57.31  (22.099) -12.79  (24.814)
Week 12 Number Analyzed 15 participants 12 participants
71.47  (17.661) -17.05  (19.186)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: Paricalcitol
Comments Overall Comparison (all time points): A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value < 0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Differenbce
Estimated Value -72.40
Confidence Interval (2-Sided) 95%
-108.05 to -36.75
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: Paricalcitol
Comments Week 2 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -62.55
Confidence Interval (2-Sided) 95%
-105.60 to -19.49
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: Paricalcitol
Comments Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -68.43
Confidence Interval (2-Sided) 95%
-130.39 to -6.47
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: Paricalcitol
Comments Week 8 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -70.09
Confidence Interval (2-Sided) 95%
-137.82 to -2.37
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: Paricalcitol
Comments Week 12 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -88.52
Confidence Interval (2-Sided) 95%
-142.04 to -35.01
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Part 2: Percentage of Participants Achieving Final Calcium Levels Within KDOQI Target Ranges
Hide Description

KDOQI recommends serum calcium is maintained within age appropriate normal ranges:

Age 6 – 12: 9.4 – 10.2 mg/dL (2.35 – 2.55 mmol/L); Age 13 – 20: 8.8 – 10.2 mg/dL (2.20 – 2.55 mmol/L).

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat dataset
Arm/Group Title Part 2: Placebo Part 2: Paricalcitol
Hide Arm/Group Description:
Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: percentage of participants
94.4 83.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: Paricalcitol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.327
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.
7.Secondary Outcome
Title Part 2: Percentage of Participants Achieving Final Phosphorus Levels Within KDOQI Target Ranges
Hide Description

The KDOQI target ranges of serum phosphorus are to maintain at or above age appropriate lower limits and no higher than the age-appropriate upper limits:

Age 6 – 12: 3.6 – 5.8 mg/dL (1.16 – 1.87 mmol/L); Age 13 – 20: 2.3 – 4.5 mg/dL (0.74 – 1.45 mmol/L).

Time Frame Week 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat dataset
Arm/Group Title Part 2: Placebo Part 2: Paricalcitol
Hide Arm/Group Description:
Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Overall Number of Participants Analyzed 18 18
Measure Type: Number
Unit of Measure: percentage of participants
72.2 50.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: Paricalcitol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.194
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage.
8.Secondary Outcome
Title Part 2: Change From Baseline in First Morning Void (FMV) Urinary Albumin to Creatinine Ratio (UACR)
Hide Description The mean change from Baseline in FMV UACR on a log scale to each post baseline visit.
Time Frame Baseline and Weeks 4, 8 and 12
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat dataset with available Baseline data, and available data at each time point
Arm/Group Title Part 2: Placebo Part 2: Paricalcitol
Hide Arm/Group Description:
Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
Overall Number of Participants Analyzed 15 16
Least Squares Mean (Standard Error)
Unit of Measure: mg/g
Week 4 Number Analyzed 15 participants 13 participants
-0.12  (0.126) -0.13  (0.132)
Week 8 Number Analyzed 14 participants 11 participants
-0.13  (0.141) -0.01  (0.155)
Week 12 Number Analyzed 12 participants 10 participants
-0.08  (0.259) 0.22  (0.292)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: Paricalcitol
Comments Overall Comparison (all time points): a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.469
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.14
Confidence Interval (2-Sided) 95%
-0.25 to 0.53
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: Paricalcitol
Comments Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.975
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value -0.01
Confidence Interval (2-Sided) 95%
-0.39 to 0.37
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: Paricalcitol
Comments Week 8 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.567
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.12
Confidence Interval (2-Sided) 95%
-0.32 to 0.56
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part 2: Placebo, Part 2: Paricalcitol
Comments Week 12 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.462
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference
Estimated Value 0.30
Confidence Interval (2-Sided) 95%
-0.53 to 1.12
Estimation Comments [Not Specified]
Time Frame Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Part 1: Paricalcitol Part 2: Placebo Part 2: Paricalcitol Part 2: Placebo/Paricalcitol Part 2: Paricalcitol/Paricalcitol
Hide Arm/Group Description Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. Participants received placebo capsules three times a week for 12 weeks during the double-blind treatment phase. Participants received paricalcitol three times a week (TIW) for 12 weeks during the double-blind treatment period. The initial dose of paricalcitol was 1 µg TIW. Doses could be adjusted based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) levels. Participants who received placebo in the double-blind treatment phase received open-label paricalcitol at an initial dose of 1 µg three times a week in the open- label treatment phase (Weeks 12-24). Doses could be adjusted based on chemistry evaluations to target KDOQI levels. Participants who received paricalcitol during the double-blind treatment period continued to receive paricalcitol three times a week during the open-label period (Weeks 12-24).
All-Cause Mortality
Part 1: Paricalcitol Part 2: Placebo Part 2: Paricalcitol Part 2: Placebo/Paricalcitol Part 2: Paricalcitol/Paricalcitol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Part 1: Paricalcitol Part 2: Placebo Part 2: Paricalcitol Part 2: Placebo/Paricalcitol Part 2: Paricalcitol/Paricalcitol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   2/18 (11.11%)   0/18 (0.00%)   1/16 (6.25%)   1/13 (7.69%) 
Gastrointestinal disorders           
ABDOMINAL PAIN  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
Infections and infestations           
VIRAL INFECTION  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
Investigations           
BLOOD CREATININE INCREASED  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
Psychiatric disorders           
HOMICIDAL IDEATION  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
SUICIDAL IDEATION  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
Renal and urinary disorders           
RENAL FAILURE CHRONIC  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/13 (7.69%) 
RENAL IMPAIRMENT  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
Vascular disorders           
HYPERTENSIVE CRISIS  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/13 (7.69%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1: Paricalcitol Part 2: Placebo Part 2: Paricalcitol Part 2: Placebo/Paricalcitol Part 2: Paricalcitol/Paricalcitol
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/12 (16.67%)   15/18 (83.33%)   7/18 (38.89%)   12/16 (75.00%)   5/13 (38.46%) 
Blood and lymphatic system disorders           
ANAEMIA  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
IRON DEFICIENCY ANAEMIA  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
LYMPHADENOPATHY  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
Ear and labyrinth disorders           
EAR PAIN  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  2/16 (12.50%)  0/13 (0.00%) 
Endocrine disorders           
HYPERPARATHYROIDISM  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
Gastrointestinal disorders           
ABDOMINAL PAIN  1  1/12 (8.33%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
CONSTIPATION  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
DIARRHOEA  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
GASTRITIS  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/13 (7.69%) 
NAUSEA  1  1/12 (8.33%)  0/18 (0.00%)  1/18 (5.56%)  1/16 (6.25%)  0/13 (0.00%) 
TOOTHACHE  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
VOMITING  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
General disorders           
FEELING HOT  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/13 (7.69%) 
OEDEMA PERIPHERAL  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
PYREXIA  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
Infections and infestations           
ACUTE SINUSITIS  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
CONJUNCTIVITIS  1  0/12 (0.00%)  0/18 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  1/13 (7.69%) 
GASTROENTERITIS  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
HERPES SIMPLEX  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
IMPETIGO  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
INFLUENZA  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
NASOPHARYNGITIS  1  0/12 (0.00%)  2/18 (11.11%)  0/18 (0.00%)  1/16 (6.25%)  2/13 (15.38%) 
OTITIS MEDIA  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
PARONYCHIA  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
PHARYNGITIS STREPTOCOCCAL  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  2/16 (12.50%)  0/13 (0.00%) 
RHINITIS  1  0/12 (0.00%)  0/18 (0.00%)  3/18 (16.67%)  0/16 (0.00%)  0/13 (0.00%) 
TOOTH INFECTION  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
UPPER RESPIRATORY TRACT INFECTION  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  2/16 (12.50%)  0/13 (0.00%) 
VIRAL INFECTION  1  0/12 (0.00%)  2/18 (11.11%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
Injury, poisoning and procedural complications           
INJURY  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
Investigations           
BLOOD POTASSIUM INCREASED  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
VITAMIN D DECREASED  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
Metabolism and nutrition disorders           
ACIDOSIS  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
HYPERCALCAEMIA  1  0/12 (0.00%)  2/18 (11.11%)  1/18 (5.56%)  3/16 (18.75%)  0/13 (0.00%) 
HYPERKALAEMIA  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  3/16 (18.75%)  0/13 (0.00%) 
HYPERPHOSPHATAEMIA  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  2/16 (12.50%)  0/13 (0.00%) 
METABOLIC ACIDOSIS  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
Musculoskeletal and connective tissue disorders           
ARTHRALGIA  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
MUSCLE SPASMS  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  1/13 (7.69%) 
Nervous system disorders           
DIZZINESS  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/13 (7.69%) 
HEADACHE  1  1/12 (8.33%)  1/18 (5.56%)  0/18 (0.00%)  1/16 (6.25%)  1/13 (7.69%) 
SYNCOPE  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
Psychiatric disorders           
THINKING ABNORMAL  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  0/16 (0.00%)  0/13 (0.00%) 
Renal and urinary disorders           
MICTURITION URGENCY  1  0/12 (0.00%)  0/18 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  0/13 (0.00%) 
PROTEINURIA  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
RENAL FAILURE CHRONIC  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders           
ASTHMA  1  0/12 (0.00%)  0/18 (0.00%)  1/18 (5.56%)  0/16 (0.00%)  0/13 (0.00%) 
COUGH  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  1/16 (6.25%)  1/13 (7.69%) 
EPISTAXIS  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  1/13 (7.69%) 
NASAL CONGESTION  1  0/12 (0.00%)  1/18 (5.56%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
OROPHARYNGEAL PAIN  1  0/12 (0.00%)  1/18 (5.56%)  1/18 (5.56%)  1/16 (6.25%)  0/13 (0.00%) 
RHINORRHOEA  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
WHEEZING  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/13 (7.69%) 
Skin and subcutaneous tissue disorders           
ACNE  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
COLD SWEAT  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  0/16 (0.00%)  1/13 (7.69%) 
INGROWING NAIL  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
RASH  1  0/12 (0.00%)  0/18 (0.00%)  0/18 (0.00%)  1/16 (6.25%)  0/13 (0.00%) 
Vascular disorders           
HYPERTENSION  1  0/12 (0.00%)  1/18 (5.56%)  1/18 (5.56%)  0/16 (0.00%)  0/13 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 17.1
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
Name/Title: Global Medical Services
Organization: AbbVie (prior sponsor, Abbott)
Phone: 800-633-9110
Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01020487     History of Changes
Other Study ID Numbers: M10-149
2010-019439-37 ( EudraCT Number )
First Submitted: November 13, 2009
First Posted: November 24, 2009
Results First Submitted: February 13, 2017
Results First Posted: March 29, 2017
Last Update Posted: July 2, 2018