| Trial ID: | L0445 |
| Source ID: | NCT02497300
|
| Associated Drug: |
Spironolactone
|
| Title: |
Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease
|
| Acronym: |
VEMAKD
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02497300/results
|
| Conditions: |
Chronic Kidney Disease|Albuminuria
|
| Interventions: |
DRUG: Spironolactone|DRUG: Amiloride
|
| Outcome Measures: |
Primary: Difference in 24 Hour Ambulatory Systolic Blood Pressure, The study was not able to meet its recruitment goal, and participant numbers were too low to test the intended primary outcome of "Difference in percent change of ultrasound-guided flow-mediated dilation between 6 weeks of spironolactone vs. 6 weeks of amiloride." The change in 24hr ABPM systolic BP (Baseline - 6 week) is reported here., 6 weeks|Change in Oxidative Stress as Measured by Urine Levels of F2-isoprostanes, Difference in level of urine 8-iso-prostaglandin-F2-alpha per mg of creatinine levels between 6 weeks of spironolactone vs. 6 weeks of amiloride., 6 weeks|Change in Albuminuria, Change of the urine albumin-to-creatinine ratio (baseline - post-study med) after 6 weeks of spironolactone vs. 6 weeks of amiloride., 6 weeks | Secondary: Change in Serum Potassium, Difference in serum potassium levels (baseline - post-medication) after 6 weeks of spironolactone vs. 6 weeks of amiloride., 6 weeks|Change in Serum Creatinine (Baseline - Post-medication), Difference in serum creatinine (baseline - post-medication) after 6 weeks of spironolactone vs. 6 weeks of amiloride., 6 weeks
|
| Sponsor/Collaborators: |
Sponsor: University of Alabama at Birmingham | Collaborators: National Institutes of Health (NIH)
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
21
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-03
|
| Completion Date: |
2021-07
|
| Results First Posted: |
2022-12-21
|
| Last Update Posted: |
2022-12-21
|
| Locations: |
Hypertension Research Clinic at UAB, Birmingham, Alabama, 35294, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02497300
|
