Study to Assess Patient Management Practices and Quality of Life With Paricalcitol Capsules in the Treatment of Secondary Hyperparathyroidism in Stage 3-5 Chronic Kidney Disease Patients Not Yet on Dialysis (CAPITOL)

This study has been completed.
Sponsor:
Collaborator:
Pharma Consulting Group AB
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01265992
First received: November 29, 2010
Last updated: January 22, 2014
Last verified: January 2014
Results First Received: November 8, 2013  
Study Type: Observational
Study Design: Time Perspective: Prospective
Conditions: Secondary Hyperparathyroidism
Chronic Kidney Disease

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Paricalcitol Capsules Patients with secondary hyperparathyroidism associated with Stage 3 - 5 chronic kidney disease (CKD) and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.

Participant Flow:   Overall Study
    Paricalcitol Capsules  
STARTED     50  
Received Treatment     49  
COMPLETED     41  
NOT COMPLETED     9  
Lost to Follow-up                 1  
Withdrawal by Subject                 1  
Adverse Event                 1  
Administrative reasons                 2  
Stopped treatment                 3  
Did not receive treatment                 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.
Full analysis set, defined as all included participants who received at least 1 dose of paricalcitol capsules.

Reporting Groups
  Description
Paricalcitol Capsules Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.

Baseline Measures
    Paricalcitol Capsules  
Number of Participants  
[units: participants]
  49  
Age  
[units: years]
Mean ± Standard Deviation
  63.7  ± 11.5  
Gender  
[units: participants]
 
Female     11  
Male     38  
Race/Ethnicity, Customized  
[units: participants]
 
White     49  
Black     0  
Asian     0  
American (Indian/Alaska Native)     0  
Other     0  
Region of Enrollment  
[units: participants]
 
Sweden     49  



  Outcome Measures
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1.  Primary:   Change From Baseline in Intact Parathyroid Hormone at 6 Months   [ Time Frame: Baseline and 6 months ]

2.  Primary:   Percentage of Participants With Intact Parathyroid Hormone Within K/DOQI Target Range at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

3.  Primary:   Percentage of Participants With Elevated Serum-Phosphorus (s-P) Levels at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

4.  Primary:   Percentage of Participants With Elevated Serum-Calcium (s-Ca) Levels at Baseline and 6 Months   [ Time Frame: Baseline and 6 months ]

5.  Secondary:   Change From Baseline in Proteinuria   [ Time Frame: Baseline and Month 6 ]

6.  Secondary:   Percentage of Participants With a Reduction of Proteinuria of at Least 15% From Baseline   [ Time Frame: Baseline and 6 months ]

7.  Secondary:   Change From Baseline in Quality of Life Assessed by the Kidney Disease Quality of Life-Short Form (KDQOL-SF)   [ Time Frame: Baseline and 6 months ]

8.  Secondary:   Total Direct Costs of Care Associated With Secondary Hyperparathyroidism   [ Time Frame: 6 months ]

9.  Secondary:   Total Indirect Costs of Care Associated With Secondary Hyperparathyroidism   [ Time Frame: 6 months ]

10.  Secondary:   Number of Participants Using Concomitant Medications at Baseline   [ Time Frame: Baseline ]


  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


No publications provided


Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01265992     History of Changes
Other Study ID Numbers: P12-270
Study First Received: November 29, 2010
Results First Received: November 8, 2013
Last Updated: January 22, 2014
Health Authority: Sweden: Regional Ethical Review Board