Study to Evaluate Safety of Vitamin D Receptor Activators in Patients Ages 0 to 16 With Chronic Kidney Disease Stage 5 Receiving Peritoneal Dialysis Within Current Clinical Practice

This study has been terminated.
(Terminated after FDA agreement.)
Sponsor:
Collaborator:
North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01134315
First received: May 28, 2010
Last updated: May 17, 2013
Last verified: May 2013
Results First Received: May 17, 2013  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Secondary Hyperparathyroidism
End-Stage Renal Disease
Interventions: Drug: Paricalcitol
Drug: Calcitriol

  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
Paricalcitol Pediatric participants who received paricalcitol capsules to treat secondary hyperparathyroidism (SHPT). Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
Calcitriol Pediatric participants who received calcitriol to treat secondary hyperparathyroidism (SHPT). Calcitriol was prescribed by each physician under the usual and customary practice of that physician.

Participant Flow:   Overall Study
    Paricalcitol     Calcitriol  
STARTED     21     40  
COMPLETED     12 [1]   21 [1]
NOT COMPLETED     9     19  
Adverse Event                 1                 2  
Other Reason                 8                 17  
[1] Completed study drug treatment during the observational study (ie, prior to study termination).



  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
Paricalcitol Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
Calcitriol Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
Total Total of all reporting groups

Baseline Measures
    Paricalcitol     Calcitriol     Total  
Number of Participants  
[units: participants]
  21     40     61  
Age, Customized  
[units: participants]
     
<8 years     5     19     24  
>=8 years     16     21     37  
Gender  
[units: participants]
     
Female     7     12     19  
Male     14     28     42  
Region of Enrollment  
[units: participants]
     
United States     21     40     61  



  Outcome Measures
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1.  Primary:   Percentage of Participants With at Least One Incidence of Hypercalcemia   [ Time Frame: Monitored from time of informed consent through end of study + 30 days (total of 745 days). ]

2.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious AEs (SAEs), Deaths and Discontinuations Due to AEs   [ Time Frame: Monitored from time of informed consent through end of study + 30 days (total of 745 days). ]

3.  Secondary:   Mean Baseline (BL) and Change From Baseline in Potassium, Sodium, Chloride, Bicarbonate at Final Visit (FV)   [ Time Frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) ]

4.  Secondary:   Mean Baseline (BL) and Change From Baseline in Calcium, Inorganic Phosphate (IP), Blood Urea Nitrogen (BUN), Creatinine at Final Visit (FV)   [ Time Frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) ]

5.  Secondary:   Mean Baseline and Change From Baseline in 25-Hydroxy Vitamin D3 at Final Visit (FV)   [ Time Frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) ]

6.  Secondary:   Mean Baseline and Change From Baseline in 1,25-Dihydroxy Vitamin D3 at Final Visit (FV)   [ Time Frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) ]

7.  Secondary:   Mean Baseline and Change From Baseline in Parathyroid Hormone at Final Visit (FV)   [ Time Frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) ]

8.  Secondary:   Mean Baseline and Change From Baseline in Albumin at Final Visit (FV)   [ Time Frame: Baseline, Final Visit (defined as the last post-baseline observation, up to end of study [715 days]) ]


  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: AbbVie
phone: 800-633-9110


No publications provided


Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01134315     History of Changes
Other Study ID Numbers: P12-053
Study First Received: May 28, 2010
Results First Received: May 17, 2013
Last Updated: May 17, 2013
Health Authority: United States: Food and Drug Administration