Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects

This study has been terminated.
(Low enrollment rate)
Sponsor:
Collaborator:
Statistika Consultoria Ltda
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00664430
First received: April 21, 2008
Last updated: January 18, 2012
Last verified: January 2012
Results First Received: June 3, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Secondary Hyperparathyroidism
Dialysis
Interventions: Drug: Calcitriol
Drug: Paricalcitol

  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
After Screening, participants entered an 8-week controlled calcitriol period. Participants whose parathyroid hormone (PTH) levels decreased after 8 weeks (i.e., participants who were not resistant to calcitriol) were discontinued from the study.

Reporting Groups
  Description
Calcitriol Challenge Followed by Paricalcitol To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.

Participant Flow:   Overall Study
    Calcitriol Challenge Followed by Paricalcitol  
STARTED     13  
COMPLETED     0 [1]
NOT COMPLETED     13  
[1] Study terminated early due to low enrollment rate.



  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
Calcitriol Challenge Followed by Paricalcitol To confirm this resistance, participants began a controlled calcitriol therapy period. After this period, participants whose parathyroid hormone (PTH) levels were not reduced according to parameters in protocol were to begin a paricalcitol titration period of up to 4 months, followed by paricalcitol therapy for up to 1 year.

Baseline Measures
    Calcitriol Challenge Followed by Paricalcitol  
Number of Participants  
[units: participants]
  13  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     12  
>=65 years     1  
Gender  
[units: participants]
 
Female     6  
Male     7  
Region of Enrollment  
[units: participants]
 
Brazil     13  



  Outcome Measures
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1.  Primary:   Proportion of Participants With a 50% Reduction in Parathyroid Hormone (PTH) Levels Relative to Visit 4 Values   [ Time Frame: Up to Week 24 ]

2.  Secondary:   Changes in Bone Remodeling Markers Over Time   [ Time Frame: Every 3 months ]

3.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: Up to 1 year ]


  Serious Adverse Events


  Other Adverse Events


  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
Early termination leading to no efficacy evaluation. All adverse events occurred during calcitriol challenge phase.  


Results Point of Contact:  
Name/Title: Global Medical Services
Organization: Abbott
phone: 800-633-9110


No publications provided


Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00664430     History of Changes
Other Study ID Numbers: W10-131
Study First Received: April 21, 2008
Results First Received: June 3, 2010
Last Updated: January 18, 2012
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency