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Inflammation in Chronic Kidney Disease and Cardiovascular Disease - The Role of Genetics and Interleukin-1 Receptor Antagonist (IL-1ra)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00897715
First received: May 8, 2009
Last updated: August 23, 2016
Last verified: August 2016
Results First Received: February 18, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Chronic Kidney Disease
Cardiovascular Disease
Interventions: Drug: Rilonacept
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
This study was conducted at the VA Nashville between 01/2013 and 02/2015. Note that essentially the same study was also conducted at the University of Colorado (NCT01663103). Results were combined with Colorado for publication. However, the results reported here are only based on the subjects enrolled at the VA Nashville.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There is about a 2-week screening period between enrollment and assignment to a treatment group to access inclusion/exclusion criteria. Although 45 subjects were enrolled, only 15 subjects were assigned to a treatment group (30 subjects were screen failures).

Reporting Groups
  Description
Interleukin-1 Receptor Antagonist

active drug

Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks

Placebo

matching placebo

Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks


Participant Flow:   Overall Study
    Interleukin-1 Receptor Antagonist   Placebo
STARTED   8   7 
COMPLETED   6   6 
NOT COMPLETED   2   1 
Lost to Follow-up                0                1 
Physician Decision                1                0 
increased risk of infection                1                0 



  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
Interleukin-1 Receptor Antagonist

active drug

Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks

Placebo

matching placebo

Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks

Total Total of all reporting groups

Baseline Measures
   Interleukin-1 Receptor Antagonist   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   7   15 
Age 
[Units: Years]
Mean (Standard Deviation)
 62  (11.5)   67  (6.2)   64  (9.4) 
Gender 
[Units: Participants]
     
Female   0   1   1 
Male   8   6   14 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   1   1   2 
Not Hispanic or Latino   7   6   13 
Unknown or Not Reported   0   0   0 
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   0   1   1 
White   8   6   14 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   8   7   15 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in the Concentration of High Sensitivity C-Reactive Protein (hsCRP) From Baseline to 12 Weeks   [ Time Frame: baseline and 12 weeks ]

2.  Secondary:   Change in Concentration of Interleukin-6 (IL-6) From Baseline to 12 Weeks   [ Time Frame: baseline and 12 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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Adriana Hung
Organization: VA Tennessee Valley Healthcare System.
phone: 615-873-7480
e-mail: adriana.hung@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00897715     History of Changes
Other Study ID Numbers: CDA-2-031-09S
Study First Received: May 8, 2009
Results First Received: February 18, 2016
Last Updated: August 23, 2016
Health Authority: United States: Federal Government