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Evaluate Safety and Efficacy of Paricalcitol in Reducing Serum Intact Parathyroid Hormone in Chronic Kidney Disease

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ClinicalTrials.gov Identifier: NCT01071070
Recruitment Status : Completed
First Posted : February 19, 2010
Results First Posted : January 26, 2012
Last Update Posted : January 26, 2012
Sponsor:
Information provided by (Responsible Party):
Abbott

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Chronic Kidney Disease
Intervention: Drug: paricalcitol

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled in the study at investigative sites in China. Recruitment began in October 2009 and ended in July 2010. The study population consisted of participants with Stage 5 chronic kidney disease who were receiving hemodialysis.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
If subjects were receiving vitamin D receptor (VDR) activators, they participated in a Washout Phase for 2 weeks prior to entering into the Screening Phase in order to wash out any VDR activators and their potential hysteresis or carryover effects.

Reporting Groups
  Description
Group 1 Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
Group 2 Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)

Participant Flow:   Overall Study
    Group 1   Group 2
STARTED   108   108 
COMPLETED   104   105 
NOT COMPLETED   4   3 
Adverse Event                0                3 
Withdrawal by Subject                1                0 
Missed 3 consecutive doses of study drug                2                0 
Hypercalcemia                1                0 



  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.
No text entered.

Reporting Groups
  Description
Group 1 Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
Group 2 Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
Total Total of all reporting groups

Baseline Measures
   Group 1   Group 2   Total 
Overall Participants Analyzed 
[Units: Participants]
 108   108   216 
Age 
[Units: Years]
Mean (Standard Deviation)
 50.5  (13.55)   50.8  (12.67)   50.6  (13.09) 
Age, Customized 
[Units: Participants]
     
< 65 years   91   93   184 
>=65 years   17   15   32 
Gender 
[Units: Participants]
     
Female   41   36   77 
Male   67   72   139 
Region of Enrollment 
[Units: Participants]
     
China   108   108   216 


  Outcome Measures

1.  Primary:   The Achievement of Two Consecutive Greater Than or Equal to 30% Decreases From Baseline Intact Parathyroid Hormone Levels   [ Time Frame: Baseline to 12 Weeks ]

2.  Secondary:   The Proportion of Subjects Achieving a Final Intact Parathyroid Hormone Value Between 150 and 300 pg/mL   [ Time Frame: Baseline to 12 Weeks ]

3.  Secondary:   The Change From Baseline to the Final Observation in Intact Parathyroid Hormone Value   [ Time Frame: Baseline to 12 Weeks ]

4.  Secondary:   The Change From Baseline to the Final Observation in Calcium   [ Time Frame: Baseline to 12 Weeks ]

5.  Secondary:   The Change From Baseline to the Final Observation in Calcium-phosphorus Product   [ Time Frame: Baseline to 12 Weeks ]

6.  Secondary:   The Change From Baseline to the Final Observation in the Vital Sign of Systolic Blood Pressure   [ Time Frame: Baseline to 12 Weeks ]

7.  Secondary:   The Change From Baseline to the Final Observation in the Vital Sign of Diastolic Blood Pressure   [ Time Frame: Baseline to 12 Weeks ]

8.  Secondary:   The Change From Baseline to the Final Observation in the Vital Sign of Heart Rate   [ Time Frame: Baseline to 12 Weeks ]

9.  Secondary:   The Proportion of Subjects With 2 Consecutive Calcium Measurements Greater Than 11.0 mg/dL (2.75 mmol/L)   [ Time Frame: Baseline to 12 weeks ]


  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
No text entered.


  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: Abbott
phone: 800-633-9110



Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT01071070     History of Changes
Other Study ID Numbers: M06-823
First Submitted: November 25, 2009
First Posted: February 19, 2010
Results First Submitted: November 7, 2011
Results First Posted: January 26, 2012
Last Update Posted: January 26, 2012