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

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ClinicalTrials.gov Identifier: NCT00897715
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : March 17, 2016
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Kidney Disease
Cardiovascular Disease
Interventions Drug: Rilonacept
Drug: Placebo
Enrollment 15
Recruitment Details 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 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).
Arm/Group Title Interleukin-1 Receptor Antagonist Placebo
Hide Arm/Group Description

active drug

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

matching placebo

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

Period Title: Overall Study
Started 8 7
Completed 6 6
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             0             1
Physician Decision             1             0
increased risk of infection             1             0
Arm/Group Title Interleukin-1 Receptor Antagonist Placebo Total
Hide Arm/Group Description

active drug

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

matching placebo

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

Total of all reporting groups
Overall Number of Baseline Participants 8 7 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 7 participants 15 participants
62  (11.5) 67  (6.2) 64  (9.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
Female
0
   0.0%
1
  14.3%
1
   6.7%
Male
8
 100.0%
6
  85.7%
14
  93.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
Hispanic or Latino
1
  12.5%
1
  14.3%
2
  13.3%
Not Hispanic or Latino
7
  87.5%
6
  85.7%
13
  86.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 15 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  14.3%
1
   6.7%
White
8
 100.0%
6
  85.7%
14
  93.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants 7 participants 15 participants
8 7 15
1.Primary Outcome
Title Change in the Concentration of High Sensitivity C-Reactive Protein (hsCRP) From Baseline to 12 Weeks
Hide Description hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was based on those subjects who completed the 12-week study, as well as 2 subjects who withdrew but completed end-of-study procedures (1 in each group). The analysis was per protocol. Note that the results reported here are only based on the subjects enrolled at the VA Nashville.
Arm/Group Title Interleukin-1 Receptor Antagonist Placebo
Hide Arm/Group Description:

active drug

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

matching placebo

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

Overall Number of Participants Analyzed 7 7
Median (Inter-Quartile Range)
Unit of Measure: mg/dl
-2.6
(-3.05 to -1.35)
0.8
(-0.05 to 1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interleukin-1 Receptor Antagonist, Placebo
Comments For the primary specific aim, we will compare the mean percent change on hsCRP between the intervention arm and the placebo arm using linear regression. We anticipate that the intervention will conservatively decrease hsCRP by 54%; whereas, placebo will have no effect. Accordingly, we have estimated that we will need 24 subjects in the experimental arm and 24 controls to have an 80% power, with an alpha of 0.05 to detect the above mentioned effect size.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments 0.05 is the a priori threshold for statistical significance
Method ANCOVA
Comments [Not Specified]
2.Secondary Outcome
Title Change in Concentration of Interleukin-6 (IL-6) From Baseline to 12 Weeks
Hide Description IL-6 is a sensitive laboratory assay for serum levels of Interleukin-6, which is a pro-inflammatory cytokine that is used to evaluate the inflammatory response
Time Frame baseline and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was based on those subjects who completed the 12-week study, as well as 2 subjects who withdrew but completed end-of-study procedures (1 in each group). The analysis was per protocol. Note that the results reported here are only based on the subjects enrolled at the VA Nashville
Arm/Group Title Interleukin-1 Receptor Antagonist Placebo
Hide Arm/Group Description:

active drug

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

matching placebo

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

Overall Number of Participants Analyzed 7 7
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
-0.63
(-0.98 to 0.00)
0.05
(-0.18 to 0.53)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Interleukin-1 Receptor Antagonist, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments 0.05 is the a priori threshold for statistical significance
Method ANCOVA
Comments [Not Specified]
Time Frame 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Interleukin-1 Receptor Antagonist Placebo
Hide Arm/Group Description

active drug

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

matching placebo

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

All-Cause Mortality
Interleukin-1 Receptor Antagonist Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Interleukin-1 Receptor Antagonist Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Interleukin-1 Receptor Antagonist Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/8 (50.00%)      3/7 (42.86%)    
Cardiac disorders     
heart arrhythmia *  0/8 (0.00%)  0 1/7 (14.29%)  1
Gastrointestinal disorders     
cramps *  1/8 (12.50%)  1 0/7 (0.00%)  0
General disorders     
back pain *  1/8 (12.50%)  2 0/7 (0.00%)  0
burn *  1/8 (12.50%)  1 0/7 (0.00%)  0
Infections and infestations     
infection *  0/8 (0.00%)  0 1/7 (14.29%)  1
Nervous system disorders     
nerve puncture *  0/8 (0.00%)  0 1/7 (14.29%)  1
Skin and subcutaneous tissue disorders     
injection site reaction *  1/8 (12.50%)  1 0/7 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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
Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00897715     History of Changes
Other Study ID Numbers: CDA-2-031-09S
First Submitted: May 8, 2009
First Posted: May 12, 2009
Results First Submitted: February 18, 2016
Results First Posted: March 17, 2016
Last Update Posted: February 25, 2019