The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4

This study has been completed.
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT00497146
First received: July 3, 2007
Last updated: March 8, 2013
Last verified: March 2013
Results First Received: September 22, 2011  
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
Left Ventricular Hypertrophy
Interventions: Drug: paricalcitol
Drug: placebo

  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
Participants were enrolled in the study at US and ex-US investigative sites. Recruitment began in March 2008 and ended in December 2009. The study population consisted of participants with Stage 3/4 chronic kidney disease who had a diagnosis of left ventricular hypertrophy confirmed by echocardiogram and cardiac magnetic resonance imaging.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Paricalcitol Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Placebo Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.

Participant Flow for 2 periods

Period 1:   Treatment Period
    Paricalcitol     Placebo  
STARTED     115     112  
COMPLETED     88     91  
NOT COMPLETED     27     21  
Adverse Event                 6                 2  
Withdrawal by Subject                 5                 9  
Lost to Follow-up                 1                 3  
Required dialysis                 4                 1  
Change in RAAS inhibitor therapy                 5                 2  
Unable to dose reduce per protocol                 4                 1  
Other Reason                 2                 3  

Period 2:   Long-term Follow-up Period
    Paricalcitol     Placebo  
STARTED     65     72  
COMPLETED     50     66  
NOT COMPLETED     15     6  
Adverse Event                 2                 2  
Withdrawal by Subject                 8                 2  
Lost to Follow-up                 5                 1  
Other                 0                 1  



  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.
No text entered.

Reporting Groups
  Description
Paricalcitol Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Placebo Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Total Total of all reporting groups

Baseline Measures
    Paricalcitol     Placebo     Total  
Number of Participants  
[units: participants]
  115     112     227  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     56     51     107  
>=65 years     59     61     120  
Age  
[units: years]
Mean ± Standard Deviation
  64.3  ± 11.30     65.7  ± 12.20     65.0  ± 11.75  
Gender  
[units: participants]
     
Female     36     33     69  
Male     79     79     158  
Baseline RAAS Status [1]
[units: participants]
     
Yes     90     87     177  
No     25     25     50  
Diabetic Status  
[units: participants]
     
Type I     4     1     5  
Type II     59     56     115  
None     52     55     107  
Age at Beginning of Long term Follow-up Period [2]
[units: years]
Mean ± Standard Deviation
  64.6  ± 11.01     66.5  ± 12.09     65.6  ± 11.58  
Gender at Beginning of Long term Follow-up Period  
[units: participants]
     
Female     20     25     45  
Male     45     47     92  
[1] Baseline renin angiotensin-aldosterone system (RAAS) status refers to whether or not (yes/no) the participant was receiving RAAS inhibitor therapy at baseline.
[2] Age demographics for the long-term follow-up population include data for 65 and 72 participants in the paricalcitol and placebo groups, respectively.



  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 to 48 weeks ]

2.  Secondary:   Change in Diastolic Mitral Annular Relaxation Velocity (E')   [ Time Frame: Baseline to 48 weeks ]

3.  Secondary:   Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E')   [ Time Frame: Baseline to 48 weeks ]

4.  Secondary:   Change in E-wave Deceleration Time (DT)   [ Time Frame: Baseline to 48 weeks ]

5.  Secondary:   Change in Isovolumetric Relaxation Time (IVRT)   [ Time Frame: Baseline to 48 weeks ]

6.  Secondary:   Change in Left Atrial Volume   [ Time Frame: Baseline to 48 weeks ]

7.  Secondary:   Change in Plasma Triiodothyronine (T3)   [ Time Frame: Baseline to 48 weeks ]

8.  Secondary:   Change in Interleukin-6 (IL-6)   [ Time Frame: Baseline to 48 weeks ]

9.  Secondary:   Change in Troponin-T   [ Time Frame: Baseline to 48 weeks ]

10.  Secondary:   Change in B-type Natriuretic Peptide (BNP)   [ Time Frame: Baseline to 48 weeks ]

11.  Secondary:   Change in High Sensitivity C-reactive Protein (hsCRP)   [ Time Frame: Baseline to 48 weeks ]

12.  Secondary:   Change in Progression of Thoraco-abdominal Aortic Plaque Volume   [ Time Frame: Baseline to 48 weeks ]

13.  Secondary:   Change in Progression of Thoraco-abdominal Aortic Wall Volume   [ Time Frame: Baseline to 48 weeks ]

14.  Secondary:   Change in Progression of Aortic Compliance   [ Time Frame: Baseline to 48 weeks ]

15.  Secondary:   Change in Progression of Left Ventricular End-systolic Volume Index   [ Time Frame: Baseline to 48 weeks ]

16.  Secondary:   Change in Progression of Left Ventricular End-diastolic Volume Index   [ Time Frame: Baseline to 48 weeks ]

17.  Secondary:   Change in Progression of Left Ventricular Ejection Fraction   [ Time Frame: Baseline to 48 weeks ]


  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 (prior sponsor, Abbott)
phone: 800-633-9110


No publications provided by AbbVie

Publications automatically indexed to this study:

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00497146     History of Changes
Other Study ID Numbers: M10-030, 2007-001689-34
Study First Received: July 3, 2007
Results First Received: September 22, 2011
Last Updated: March 8, 2013
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Spain: Agencia Española de Medicamentos y Productos Sanitarios
United Kingdom: Medicines and Healthcare Products Regulatory Agency