| Trial ID: | L0299 |
| Source ID: | NCT04510844
|
| Associated Drug: |
Evolocumab
|
| Title: |
Evolocumab In Advanced Chronic Kidney Disease Trial
|
| Acronym: |
EVO-CKD
|
| Status: |
WITHDRAWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Diseases|High Cholesterol
|
| Interventions: |
DRUG: Evolocumab|OTHER: Placebo
|
| Outcome Measures: |
Primary: Absolute change in LDL cholesterol concentration, The primary endpoint is selected to evaluate the key pharmacologic mechanism underlying Evolocumab's cardiovascular benefits. This will be analyzed with Lipid parameters., Baseline, Week 52 | Secondary: Number of Serious Adverse Events (SAEs), Baseline, Week 52|Change in coronary flow reserve (CFR), Change in coronary flow reserve (CFR), the key secondary efficacy endpoint, is a measure of overall cardiovascular health.This test provides an integrative measure of myocardial microvascular supply and myocardial endothelial function as well as large vessel coronary flow. Change in coronary flow reserve over one year as measured by cardiac PET scanning., Baseline, Week 52
|
| Sponsor/Collaborators: |
Sponsor: NYU Langone Health
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
0
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2021-03-01
|
| Completion Date: |
2021-10-01
|
| Results First Posted: |
|
| Last Update Posted: |
2022-07-28
|
| Locations: |
NYU Langone Nephrology Associates - Long Island, Mineola, New York, 11501, United States|NYU Langone Health, New York, New York, 10010, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04510844
|
