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The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5

This study has been terminated.
(This study was prematurely terminated due to low enrollment)
Sponsor:
Collaborators:
Massachusetts General Hospital
Harvard University
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00616902
First received: February 5, 2008
Last updated: January 18, 2012
Last verified: January 2012
History of Changes
Results First Received: May 21, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Chronic Kidney Disease (CKD) Stage 5
Hypertrophy, Left Ventricular
Interventions: Drug: paricalcitol injection 4 mcg/mL
Drug: Placebo Injection 4 mcg/mL

  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
A total of 220 participants were to be randomized in a 1:1 ratio to each treatment group to receive paricalcitol injection or placebo at 75 US and ex-US sites. A stratified randomization scheme was used to ensure balance among treatment groups with respect to country, sex, and baseline Renin Angiotensin-Aldosterone System (RAAS) inhibitor use.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Screening Period consisted of 3 visits and occurred within 6 weeks prior to participant randomization and enrollment into the Treatment Period of the study. For enrollment, all screening labs and echocardiogram requirements had to be met. Also, a technically adequate cardiac MRI had to be obtained for participant to be randomized into study.

Reporting Groups
  Description
Paricalcitol Injection 4 Mcg/mL Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Placebo Injection 4 Mcg/mL Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.

Participant Flow:   Overall Study
    Paricalcitol Injection 4 Mcg/mL     Placebo Injection 4 Mcg/mL  
STARTED     6     6  
COMPLETED     0     0  
NOT COMPLETED     6     6  
Termination of study                 6                 6  



  Baseline Characteristics
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Reporting Groups
  Description
Paricalcitol Injection 4 Mcg/mL Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Placebo Injection 4 Mcg/mL Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
Total Total of all reporting groups

Baseline Measures
    Paricalcitol Injection 4 Mcg/mL     Placebo Injection 4 Mcg/mL     Total  
Number of Participants  
[units: participants]
 		  6     6     12  
Age, Customized  
[units: participants]
 		     
< 40 years     1     0     1  
40 - < 60 years     3     2     5  
>= 60 years     2     4     6  
Age  
[units: years]
Mean ± Standard Deviation 		  54.5  ± 16.01     58.8  ± 7.05     56.7  ± 12.01  
Gender  
[units: participants]
 		     
Female     4     3     7  
Male     2     3     5  
Race (NIH/OMB)  
[units: participants]
 		     
American Indian or Alaska Native     0     0     0  
Asian     2     0     2  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     2     3  
White     3     4     7  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  



  Outcome Measures
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1.  Primary:   Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)   [ Time Frame: Baseline, 24 Weeks, and 48 Weeks/Early Termination ]
  Show Outcome Measure 1

2.  Secondary:   Change From Baseline in the Echocardiographic Assessment of Diastolic Function Assessed by Evaluating Changes in Diastolic Mitral Annular Relaxation Velocity (E') Over 48 Weeks.   [ Time Frame: Baseline, 24 Weeks, and 48 Weeks/Early Termination ]
  Show Outcome Measure 2

3.  Secondary:   Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Isovolumetric Relaxation Time (IVRT) Over 48 Weeks.   [ Time Frame: Baseline, 24 Weeks, and 48 Weeks/Early Termination ]
  Show Outcome Measure 3

4.  Secondary:   Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Peak E-wave Velocity to Lateral E-wave Velocity (E/E') Over 48 Weeks.   [ Time Frame: Baseline, Week 24, and Week 48/Early Termination ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function E-wave Deceleration Time (DT) Over 48 Weeks   [ Time Frame: Baseline, 24 Weeks, and 48 Weeks/Early Termination ]
  Show Outcome Measure 5

6.  Secondary:   Change From Baseline in Biological Marker Triiodothyronine (T3).   [ Time Frame: Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) ]
  Show Outcome Measure 6

7.  Secondary:   Change From Baseline in Biological Marker Plasma Troponin-T Over 48 Weeks   [ Time Frame: Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) ]
  Show Outcome Measure 7

8.  Secondary:   Change From Baseline in Biological Marker Plasma Interleukin-6 (IL-6) Over 48 Weeks   [ Time Frame: Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in Biological Marker Plasma High Sensitivity C-reactive Protein (hsCRP) Over 48 Weeks   [ Time Frame: Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) ]
  Show Outcome Measure 9

10.  Secondary:   Change From Baseline in Biological Marker Plasma B-Type Natriuretic Peptide (BNP)   [ Time Frame: Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) ]
  Show Outcome Measure 10


  Serious Adverse Events
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  Other Adverse Events
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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.


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
This study was prematurely terminated due to low enrollment. Only 12 subjects were randomized at 10 investigative sites with none of the subjects completing the study.  


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


No publications provided by Abbott

Publications automatically indexed to this study:


Responsible Party: Abbott
ClinicalTrials.gov Identifier: NCT00616902     History of Changes
Other Study ID Numbers: M10-221, 2007-005092-33
Study First Received: February 5, 2008
Results First Received: May 21, 2010
Last Updated: January 18, 2012
Health Authority: United States: Food and Drug Administration