Metabolic Effects of Paricalcitol

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Ian deBoer, University of Washington
ClinicalTrials.gov Identifier:
NCT01003275
First received: October 26, 2009
Last updated: April 9, 2014
Last verified: April 2014
Results First Received: June 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Kidney Disease
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
Participants were recruited from 2010 through 2011 from Nephrology clinics associated with the University of Washington.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None.

Reporting Groups
  Description
Paricalcitol Followed by Placebo Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
Placebo Followed by Paricalcitol Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.

Participant Flow:   Overall Study
    Paricalcitol Followed by Placebo     Placebo Followed by Paricalcitol  
STARTED     11     11  
COMPLETED     10     11  
NOT COMPLETED     1     0  



  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.
No text entered.

Reporting Groups
  Description
Paricalcitol Followed by Placebo Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
Placebo Followed by Paricalcitol Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
Total Total of all reporting groups

Baseline Measures
    Paricalcitol Followed by Placebo     Placebo Followed by Paricalcitol     Total  
Number of Participants  
[units: participants]
  11     11     22  
Age  
[units: years]
Mean ± Standard Deviation
  66  ± 10.4     65.5  ± 13.1     65.8  ± 11.6  
Gender  
[units: participants]
     
Female     1     1     2  
Male     10     10     20  
Region of Enrollment  
[units: participants]
     
United States     11     11     22  



  Outcome Measures

1.  Primary:   Glucose Area Under the Curve (AUC)   [ Time Frame: 8 weeks ]


  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ian H. de Boer, MD, MS, Associate Professor of Medicine
Organization: University of Washington
phone: 2066165403
e-mail: deboer@u.washington.edu


Publications of Results:

Responsible Party: Ian deBoer, University of Washington
ClinicalTrials.gov Identifier: NCT01003275     History of Changes
Other Study ID Numbers: 35501-D
Study First Received: October 26, 2009
Results First Received: June 18, 2013
Last Updated: April 9, 2014
Health Authority: United States: Institutional Review Board