| Trial ID: | L0521 |
| Source ID: | NCT01663103
|
| Associated Drug: |
Rilonacept
|
| Title: |
Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01663103/results
|
| Conditions: |
Renal Insufficiency, Chronic
|
| Interventions: |
DRUG: Rilonacept|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Flow-mediated Dilation (FMD), Change in FMD after 3 months of treatment with rilonacept will be compared to change in the placebo group., 3 months after start of treatment | Secondary: Change in Aortic Pulse-wave Velocity (aPWV), Change in aPWV after 3 months of treatment with rilonacept will be compared to change in the placebo group., 3 months after start of treatment|Change in Contribution of Oxidative Stress to FMD, FMD will be assessed following acute infusion of ascorbic acid compared to saline. The improvement in FMD with ascorbic acid reflects the degree of oxidative stress contributing to impairment in FMD., 3 months after start of treatment | Other: Change in High-sensitivity C-reactive Protein (hsCRP), Change in high-sensitivity C-reactive protein (hsCRP) after 3 months of rilonacept vs. placebo will be assessed as a circulating marker of inflammation., 3 months after start of treatment|Change in Vascular Endothelial NADPH Oxidase Expression, Vascular endothelial cells will be collected and assessed for changes in protein expression of NADPH oxidase after 3 months of treatment with rilonacept vs. placebo. Protein expression is calculated as a ratio of intensity of staining in the patient cells relative to human umbilical vein endothelial cell (HUVEC) control cells. The absolute change in this ratio between baseline and week 12 is reported below., 3 months after start of treatment
|
| Sponsor/Collaborators: |
Sponsor: University of Colorado, Denver
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
42
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
|
| Start Date: |
2012-08
|
| Completion Date: |
2014-12
|
| Results First Posted: |
2016-09-12
|
| Last Update Posted: |
2016-09-12
|
| Locations: |
University of Colorado Clinical and Translational Research Center (CTRC) Outpatient Clinic, Aurora, Colorado, 80045, United States|Vanderbilt University Medical Center, Nashville, Tennessee, 37232, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01663103
|
