| Trial ID: | L0517 |
| Source ID: | NCT00897715
|
| Associated Drug: |
Rilonacept
|
| Title: |
Inflammation in Chronic Kidney Disease and Cardiovascular Disease - The Role of Genetics and Interleukin-1 Receptor Antagonist (IL-1ra)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT00897715/results
|
| Conditions: |
Chronic Kidney Disease|Cardiovascular Disease
|
| Interventions: |
DRUG: Rilonacept|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in the Concentration of High Sensitivity C-Reactive Protein (hsCRP) From Baseline to 12 Weeks, hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation, baseline and 12 weeks | Secondary: Change in Concentration of Interleukin-6 (IL-6) From Baseline to 12 Weeks, 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, baseline and 12 weeks
|
| Sponsor/Collaborators: |
Sponsor: VA Office of Research and Development
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
15
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-01-01
|
| Completion Date: |
2015-05-08
|
| Results First Posted: |
2016-03-17
|
| Last Update Posted: |
2019-10-01
|
| Locations: |
Tennessee Valley Healthcare System Nashville Campus, Nashville, TN, Nashville, Tennessee, 37212-2637, United States|Vanderbilt University, Nashville, Tennessee, 37232, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00897715
|
