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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:
ClinicalTrials.gov Identifier:
NCT01134315
First Posted: June 2, 2010
Last Update Posted: August 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
Results First Submitted: 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 
Overall Participants Analyzed 
[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



Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01134315     History of Changes
Other Study ID Numbers: P12-053
First Submitted: May 28, 2010
First Posted: June 2, 2010
Results First Submitted: May 17, 2013
Results First Posted: August 13, 2013
Last Update Posted: August 13, 2013