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Observational Study to Evaluate the Time to Achieving the Maintenance Dose of Zemplar® (Paricalcitol Injection) in the Treatment of Patients Suffering From End-stage Renal Disease and Severe Over-reactivity of the Parathyroid Glands

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ClinicalTrials.gov Identifier: NCT01273597
Recruitment Status : Completed
First Posted : January 10, 2011
Results First Posted : December 21, 2012
Last Update Posted : January 18, 2013
Sponsor:
Collaborator:
Planimeter Ltd
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Kidney Failure, Chronic

  Participant Flow

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
End-stage Kidney Disease With Secondary Hyperparathyroidism Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)

Participant Flow:   Overall Study
    End-stage Kidney Disease With Secondary Hyperparathyroidism
STARTED   60 
COMPLETED   52 
NOT COMPLETED   8 
Adverse Event                5 
Underwent Kidney Transplantation                2 
Reason Not Reported                1 



  Baseline Characteristics

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
End-stage Kidney Disease With Secondary Hyperparathyroidism Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)

Baseline Measures
   End-stage Kidney Disease With Secondary Hyperparathyroidism 
Overall Participants Analyzed 
[Units: Participants]
 60 
Age 
[Units: Years]
Mean (Full Range)
 57.7 
 (31 to 86) 
Gender 
[Units: Participants]
 
Female   31 
Male   29 
Region of Enrollment 
[Units: Participants]
 
Hungary   60 


  Outcome Measures

1.  Primary:   Time (in Weeks) From Treatment Initiation to Achieving Maintenance Dose of Zemplar (Paricalcitol Injection)   [ Time Frame: 6 months ]

2.  Secondary:   Number of Participants Achieving Target Intact Parathyroid Hormone (iPTH) Levels at Month 6   [ Time Frame: 6 months ]

3.  Secondary:   Country–Specific Data on the Usage of Medication Affecting Calcium (Ca) Balance   [ Time Frame: 6 months prior to start of study through 6 months of treatment ]

4.  Secondary:   Country–Specific Data on the Usage of Medication Affecting Phosphorus (P) Balance   [ Time Frame: 6 months prior to start of study through 6 months of treatment ]

5.  Secondary:   Country–Specific Data on the Usage of Medication Affecting Secondary Hyperparathyroidism   [ Time Frame: 6 months prior to start of study through 6 months of treatment ]

6.  Secondary:   Number of Participants With Hypercalcaemia During Preceding 6 Months of Conventional Vitamin D Therapy   [ Time Frame: 6 months prior to start of study through baseline ]

7.  Secondary:   Number of Participants With Hypercalcaemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment   [ Time Frame: 6 months ]

8.  Secondary:   Number of Participants With Hyperphosphataemia During Preceding Conventional Vitamin D Therapy   [ Time Frame: 6 months prior to start of study through baseline ]

9.  Secondary:   Number of Participants With Hyperphosphataemia During 6 Months of Selective Vitamin D Receptor Activator (Paricalcitol) Treatment   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  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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  More Information

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



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01273597     History of Changes
Other Study ID Numbers: P12-644
First Submitted: November 22, 2010
First Posted: January 10, 2011
Results First Submitted: November 21, 2012
Results First Posted: December 21, 2012
Last Update Posted: January 18, 2013