Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT) (PACE)

This study has been completed.
Sponsor:
Collaborators:
Henry Ford Hospital
Feinberg School of Medicine, Northwestern University
NorthShore University HealthSystem
Abbott
Information provided by (Responsible Party):
Daniel W. Coyne, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00823303
First received: December 12, 2008
Last updated: August 4, 2014
Last verified: August 2014
Results First Received: June 5, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Secondary Hyperparathyroidism
Chronic Kidney 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

titrated to achieve 40-60% PTH suppression

Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression

Calcitriol

titrated to achieve 40-60% PTH suppression

Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression


Participant Flow:   Overall Study
    Paricalcitol     Calcitriol  
STARTED     54     56  
COMPLETED     45     45  
NOT COMPLETED     9     11  



  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.
Stage 3 and 4 CKD with SHPT, age >18, a stable dose of phosphate binder (if receiving a binder), estimated glomerular filtration rate (eGFR) of 15-59 mL/min using the abbreviated MDRD equation, PTH >120 pg/mL, albumin-corrected calcium >8.5 mg/dL and <10.0 mg/dL, phosphorus <4.6 mg/dL.

Reporting Groups
  Description
Paricalcitol

titrated to achieve 40-60% PTH suppression

Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression

Calcitriol

titrated to achieve 40-60% PTH suppression

Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression

Total Total of all reporting groups

Baseline Measures
    Paricalcitol     Calcitriol     Total  
Number of Participants  
[units: participants]
  54     56     110  
Age  
[units: years]
Mean ± Standard Deviation
  66.6  ± 13.2     64.7  ± 12.6     65.6  ± 12.9  
Gender  
[units: participants]
     
Female     24     30     54  
Male     30     26     56  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     33     41     74  
White     18     14     32  
More than one race     0     0     0  
Unknown or Not Reported     3     1     4  



  Outcome Measures

1.  Primary:   Confirmed Hypercalcemia   [ Time Frame: 24 week treatment period ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Daniel W. Coyne
Organization: Washington University School of Medicine
phone: 3143627211
e-mail: dcoyne@dom.wustl.edu


Publications of Results:

Responsible Party: Daniel W. Coyne, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00823303     History of Changes
Other Study ID Numbers: 22095
Study First Received: December 12, 2008
Results First Received: June 5, 2014
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board