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Vascular Reactivity in Chronic Kidney Disease (CKD) Patients Receiving Paricalcitol Versus Placebo

This study has been completed.
Sponsor:
Collaborator:
Albany College of Pharmacy and Health Sciences
Information provided by (Responsible Party):
Amy Barton Pai, University of Michigan
ClinicalTrials.gov Identifier:
NCT00915876
First received: June 5, 2009
Last updated: October 7, 2016
Last verified: October 2016
Results First Received: October 7, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject)
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
No text entered.

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 Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
Placebo Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks

Participant Flow:   Overall Study
    Paricalcitol   Placebo
STARTED   20   21 
Moving Beyond First Dose   20   20 
COMPLETED   20   20 
NOT COMPLETED   0   1 
Adverse Event                0                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.
One placebo group patient dropped out due to an adverse event is not included in baseline measures or in outcome measures. Assuming 35% variability in circulating ICAM-1 concentrations,46 a sample size of 18 per group is adequate to detect a 50 percentage point difference in the percent in ICAM-1 with 80% power and an = 0.05.

Reporting Groups
  Description
Placebo Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
Paricalcitol Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
Total Total of all reporting groups

Baseline Measures
   Placebo   Paricalcitol   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Years]
Mean (Standard Deviation)
 67  (11)   64  (14)   66  (13) 
Gender 
[Units: Participants]
     
Female   7   12   19 
Male   13   8   21 
Region of Enrollment 
[Units: Participants]
     
United States   20   20   40 
estimated glomerular filtration rate 
[Units: mL/min/1.73m2]
Mean (Standard Deviation)
 36  (11)   30  (9)   35  (10) 


  Outcome Measures

1.  Primary:   Change in Circulating ICAM-1 Shown by Absolute Values at Baseline, Day 28 and Day 56   [ Time Frame: Day 28 and Day 56 ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Amy Pai
Organization: University of Michigan
phone: 7346470005
e-mail: amypai@med.umich.edu



Responsible Party: Amy Barton Pai, University of Michigan
ClinicalTrials.gov Identifier: NCT00915876     History of Changes
Other Study ID Numbers: Paricalcitol-AMC2443
Study First Received: June 5, 2009
Results First Received: October 7, 2016
Last Updated: October 7, 2016
Health Authority: United States: Institutional Review Board