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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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
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Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
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Study Type | Interventional |
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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 |
Participant Flow
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 |
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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 |
Baseline Characteristics
Arm/Group Title | Paricalcitol | |
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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 | |
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[Not Specified]
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 13 participants | |
14.5 (1.76) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 13 participants | |
Female |
8 61.5%
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Male |
5 38.5%
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Outcome Measures
Adverse Events
Limitations and Caveats
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
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 Information |
Organization: | AbbVie |
Phone: | 800-633-9110 |
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 |