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Study of Zemplar iv in Patients With End Stage Chronic Kidney Disease, Undergoing Haemodialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT01084538
First received: February 22, 2010
Last updated: September 19, 2011
Last verified: September 2011
History of Changes
Results First Received: June 30, 2011  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Parathyroid Hormone
Intervention: Drug: Zemplar iv (paricalcitol iv)

  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
Safety population consists of 181 participants who received at least one dose of drug. Of those, 175 were included in the full analysis set. Six participants were excluded; five due to initial intact parathyroid hormone values less than 300 picograms per milliliter and one suffered a serious adverse event before the first evaluation (study visit).

Reporting Groups
  Description
End Stage Chronic Kidney Disease Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.

Participant Flow:   Overall Study
    End Stage Chronic Kidney Disease  
STARTED     181  
COMPLETED     113  
NOT COMPLETED     68  
Drug not available                 30  
Adverse Event                 9  
Kidney transplant                 6  
Serious Adverse Event                 3  
Lack of effectiveness                 2  
Patient noncompliance                 2  
Hyperphosphatemia                 2  
Nodular hyperplasia of parathyroid gland                 2  
Change of residence                 2  
Over-suppression of parathyroid gland                 2  
Reason unknown                 8  



  Baseline Characteristics
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Reporting Groups
  Description
End Stage Chronic Kidney Disease Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.

Baseline Measures
    End Stage Chronic Kidney Disease  
Number of Participants  
[units: participants]
 		  175  
Age  
[units: years]
Mean ± Standard Deviation 		  55.3  ± 12.9  
Gender  
[units: participants]
 		 
Female     79  
Male     96  



  Outcome Measures
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1.  Primary:   Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline   [ Time Frame: Baseline through 12 months ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL)   [ Time Frame: Baseline through 12 months ]
  Show Outcome Measure 2

3.  Secondary:   Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL   [ Time Frame: Baseline through 12 months ]
  Show Outcome Measure 3

4.  Secondary:   Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements.   [ Time Frame: Baseline through 12 months ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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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: NCT01084538     History of Changes
Other Study ID Numbers: P10-231
Study First Received: February 22, 2010
Results First Received: June 30, 2011
Last Updated: September 19, 2011
Health Authority: Croatia: Agency for Medicinal Product and Medical Devices
Serbia and Montenegro: Agency for Drugs and Medicinal Devices