Follow-up Patients With End Stage Renal Disease Receiving Zemplar to Prevent and Treat Secondary Hyperparathyroidism

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01081665
First received: February 27, 2010
Last updated: March 26, 2012
Last verified: March 2012
Results First Received: February 7, 2012  
Study Type: Observational
Study Design: Time Perspective: Prospective
Conditions: Chronic Kidney Failure
Secondary Hyperparathyroidism

  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
Chronic Kidney Disease All eligible patients treated with IV Paricalcitol (Zemplar)

Participant Flow:   Overall Study
    Chronic Kidney Disease  
STARTED     237  
Full Analysis Set     237  
Evaluable Population     212 [1]
COMPLETED     142  
NOT COMPLETED     95  
Death                 41  
Lost to Follow-up                 18  
Withdrawal by Subject                 17  
Change of dialysis unit                 10  
Regulation of iPTH                 5  
Change in renal replacement therapy                 2  
Adverse Event                 1  
Lack of Efficacy                 1  
[1] Participants with baseline and at least 2 post-baseline parathormone measurements at 24 months.



  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.
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Reporting Groups
  Description
Chronic Kidney Disease All eligible patients treated with IV Paricalcitol (Zemplar)

Baseline Measures
    Chronic Kidney Disease  
Number of Participants  
[units: participants]
  237  
Age  
[units: years]
Mean ± Standard Deviation
  62.6  ± 13.7  
Gender  
[units: participants]
 
Female     110  
Male     127  
Region of Enrollment  
[units: participants]
 
Greece     237  
Age at chronic kidney disease diagnosis [1]
[units: years]
Mean ± Standard Deviation
  53.6  ± 14.7  
Time since chronic kidney disease diagnosis [2]
[units: years]
Mean ± Standard Deviation
  8.8  ± 6.8  
Time since starting haemodialysis [3]
[units: years]
Mean ± Standard Deviation
  3.6  ± 4.4  
Time since diagnosis of secondary hyperparathyroidism [4]
[units: years]
Mean ± Standard Deviation
  2.0  ± 3.1  
[1] The age of participants when they were diagnosed with chronic kidney disease. Based on data reported by 222 participants.
[2] The amount of time elapsed from the time the participant was diagnosed with chronic kidney disease to study entry. Based on data reported by 222 participants.
[3] At study entry, the amount of time that had elapsed from participants first starting haemodialysis, a procedure that filters the blood to remove harmful wastes.
[4] At study entry, the amount of time that had elapsed since participants were first diagnosed with hyperparathyroidism, a condition where the parathyroid glands make too much parathyroid hormone, causing an imbalance of calcium and phosphorous in the body. Based on data reported by 228 participants.



  Outcome Measures
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1.  Primary:   Safety Evaluation of Paricalcitol by Recording the Number of Hospitalizations   [ Time Frame: Baseline to Month 24 Visit ]

2.  Primary:   Safety Evaluation of Paricalcitol by Recording the Number of Days Hospitalized   [ Time Frame: Baseline to Month 24 Visit ]

3.  Secondary:   The Proportion of Patients Achieving Therapeutic Success (Defined as 40% Reduction in Base Parathormone Level and/or Parathormone Level <300 pg/ml)   [ Time Frame: Baseline to Month 24 Visit ]

4.  Secondary:   The Incidence of Clinically Significant Hypercalcemia   [ Time Frame: Baseline to Month 24 Visit ]

5.  Secondary:   The Incidence of Clinically Significant Hyperphosphatemia   [ Time Frame: Baseline to Month 24 Visit ]

6.  Secondary:   The Incidence of Clinically Significant Elevation of Calcium-phosphorous (Ca x P) Product   [ Time Frame: Baseline to Month 24 Visit ]

7.  Secondary:   To Estimate the Incidence of (S)AEs/(S)ADRs   [ Time Frame: Baseline to Month 24 Visit ]


  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: Abbott
phone: 1-800-633-9110


No publications provided


Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01081665     History of Changes
Other Study ID Numbers: P06-120
Study First Received: February 27, 2010
Results First Received: February 7, 2012
Last Updated: March 26, 2012
Health Authority: Greece: National Organization of Medicines