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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01020487
First Posted: November 24, 2009
Last Update Posted: March 29, 2017
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.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
Results First Submitted: February 13, 2017  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Part 1: Paricalcitol Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
Part 2: Placebo 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.
Part 2: Paricalcitol 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.

Participant Flow for 3 periods

Period 1:   Part 1
    Part 1: Paricalcitol   Part 2: Placebo   Part 2: Paricalcitol
STARTED   12   0   0 
COMPLETED   12   0   0 
NOT COMPLETED   0   0   0 

Period 2:   Part 2 Double-blind Treatment Period
    Part 1: Paricalcitol   Part 2: Placebo   Part 2: Paricalcitol
STARTED   0   18 [1]   19 [1] 
Received Treatment   0   18   18 
COMPLETED   0   16   13 
NOT COMPLETED   0   2   6 
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 3:   Part 2 Open-label Period
    Part 1: Paricalcitol   Part 2: Placebo   Part 2: Paricalcitol
STARTED   0   16   13 
COMPLETED   0   12   12 
NOT COMPLETED   0   4   1 
Adverse Event                0                4                1 



  Baseline Characteristics
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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.
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.

Reporting Groups
  Description
Part 1: Paricalcitol Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
Part 2: Placebo 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.
Part 2: Paricalcitol 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 Total of all reporting groups

Baseline Measures
   Part 1: Paricalcitol   Part 2: Placebo   Part 2: Paricalcitol   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   18   19   49 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
       
Part 1         
Participants Analyzed 
[Units: Participants]
 12   0   0   12 
Part 1   13.5  (1.98)         13.5  (1.98) 
Part 2         
Participants Analyzed 
[Units: Participants]
 0   18   19   37 
Part 2      13.3  (1.75)   13.9  (1.81)   13.6  (1.78) 
[1] Baseline measure data were analyzed separately for participants in Part 1 and Part 2.
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 12   18   19   49 
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 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 12   18   19   49 
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] 
[Units: Participants]
Count of Participants
       
Participants Analyzed 
[Units: Participants]
 12   18   19   49 
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] 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


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Part 1: Paricalcitol Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing. ]

2.  Primary:   Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)   [ Time Frame: Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing. ]

3.  Primary:   Part 2: Percentage of Participants Achieving Two Consecutive Reductions at Least 30% From Baseline in iPTH   [ Time Frame: 12-week double-blind treatment period ]

4.  Secondary:   Part 2: Percentage of Participants Achieving a Final iPTH Within KDOQI Target Ranges   [ Time Frame: Week 12 ]

5.  Secondary:   Part 2: Change From Baseline in iPTH to Each Post-baseline Visit   [ Time Frame: Baseline and Weeks 2, 4, 8 and 12 ]

6.  Secondary:   Part 2: Percentage of Participants Achieving Final Calcium Levels Within KDOQI Target Ranges   [ Time Frame: Week 12 ]

7.  Secondary:   Part 2: Percentage of Participants Achieving Final Phosphorus Levels Within KDOQI Target Ranges   [ Time Frame: Week 12 ]

8.  Secondary:   Part 2: Change From Baseline in First Morning Void (FMV) Urinary Albumin to Creatinine Ratio (UACR)   [ Time Frame: Baseline and Weeks 4, 8 and 12 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 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: March 29, 2017