University of Arkansas
The goal of this clinical trial is to learn if treatment with ticagrelor tablets can decrease inflammation in patients with Chronic Kidney Disease (CKD). Inflammation is thought to contribute to the risk of heart disease which is the leading cause of death in patients with CKD. Decreasing inflammation may decrease the risk of heart disease. The main questions it aims to answer are: * Why are patients with CKD at increased risk for heart disease and how to reduce that risk in the future. * If there could be new treatment options for managing inflammation in blood of patients with CKD. Researchers will compare Ticagrelor to a Placebo (a look-alike substance that contains no drug) to see if ticagrelor decreases inflammation in adult patients with CKD. A comparator (control) group not receiving the drug/placebo will consist of adults without CKD. Participants with CKD will: * Take ticagrelor 90 mg or placebo orally twice daily for 42 days * Visit the clinic once every 2 weeks for checkups, tests, and bloodwork * Participation will last approximately 12 weeks Participants without CKD (control group) will visit the clinic twice (7 weeks apart) to provide information and bloodwork. Participation will last approximately 7 weeks with additional optional visits.
This randomized, double-blind, placebo-controlled trial tests the hypothesis that platelet inhibition with ticagrelor, a P2Y12 receptor antagonist, will reduce serum inflammatory cytokine levels and improve surrogate cardiovascular (CV) markers in adult patients with chronic kidney disease (CKD) and estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73m² who do not have a CV indication for antiplatelet therapy. The primary endpoint is serum IL-1β at Day 42 vs. baseline. A parallel mechanistic arm will characterize leukocyte gene expression changes induced by P2Y12 antagonism using bulk…
INCLUSION CRITERIA Population 1: CKD Participants * Provision of signed and dated written informed consent. * Age 21 to 75 years at the time of screening, inclusive. * Diagnosis of chronic kidney disease with estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73m² as calculated by the CKD-EPI equation, confirmed from medical records or laboratory results. * Currently receiving the maximally tolerated or labeled dose of a renin-angiotensin-aldosterone system inhibitor (RAASi) as guideline-directed medical therapy (GDMT), or documentation of the reason for not receiving RAASi (e.g., int…
Ticagrelor 90 mg orally twice daily for 42 days
Placebo orally twice daily for 42 days