Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD)
|ClinicalTrials.gov Identifier: NCT01663103|
Recruitment Status : Completed
First Posted : August 13, 2012
Results First Posted : September 12, 2016
Last Update Posted : September 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Renal Insufficiency, Chronic||Drug: Rilonacept Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Interleukin-1 Trap to Treat Vascular Dysfunction in Chronic Kidney Disease (CKD)|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
12 weeks of treatment with rilonacept
12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)
Other Name: Arcalyst
Placebo Comparator: Placebo
Twelve weeks of treatment with placebo
Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)
Other Name: normal saline
- Change in Flow-mediated Dilation (FMD) [ Time Frame: 3 months after start of treatment ]Change in FMD after 3 months of treatment with rilonacept will be compared to change in the placebo group.
- Change in Aortic Pulse-wave Velocity (aPWV) [ Time Frame: 3 months after start of treatment ]Change in aPWV after 3 months of treatment with rilonacept will be compared to change in the placebo group.
- Change in Contribution of Oxidative Stress to FMD [ Time Frame: 3 months after start of treatment ]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.
- Change in High-sensitivity C-reactive Protein (hsCRP) [ Time Frame: 3 months after start of treatment ]Change in high-sensitivity C-reactive protein (hsCRP) after 3 months of rilonacept vs. placebo will be assessed as a circulating marker of inflammation.
- Change in Vascular Endothelial NADPH Oxidase Expression [ Time Frame: 3 months after start of treatment ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01663103
|United States, Colorado|
|University of Colorado Clinical and Translational Research Center (CTRC) Outpatient Clinic|
|Aurora, Colorado, United States, 80045|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232|
|Principal Investigator:||Kristen L Jablonski Nowak, Ph.D.||University of Colorado Denver Anschutz Medical Campus|