Trial · NCT02497300

Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease

NCT02497300, Phase 2, Completed, University of Alabama at Birmingham; results first posted 2022-12-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease. Trials, record NCT02497300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02497300

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease
NCT number: NCT02497300
Status: Completed
Phases: Phase 2
Enrollment: 21 participants, actual
Lead sponsor: University of Alabama at Birmingham
Conditions: Chronic Kidney Disease, Albuminuria
Interventions: Spironolactone, Amiloride
First posted: 2015-07-14
Last updated: 2022-12-21
Results first posted: 2022-12-21

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Difference in 24 Hour Ambulatory Systolic Blood Pressure	6 weeks	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.
Primary	Change in Oxidative Stress as Measured by Urine Levels of F2-isoprostanes	6 weeks	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.
Primary	Change in Albuminuria	6 weeks	Change of the urine albumin-to-creatinine ratio (baseline - post-study med) after 6 weeks of spironolactone vs. 6 weeks of amiloride.
Secondary	Change in Serum Potassium	6 weeks	Difference in serum potassium levels (baseline - post-medication) after 6 weeks of spironolactone vs. 6 weeks of amiloride.
Secondary	Change in Serum Creatinine (Baseline - Post-medication)	6 weeks	Difference in serum creatinine (baseline - post-medication) after 6 weeks of spironolactone vs. 6 weeks of amiloride.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Difference in 24 Hour Ambulatory Systolic Blood Pressure	6 weeks	Some participants had missing or incomplete 24 hour ambulatory blood pressure monitoring	mm Hg	MEAN
PRIMARY	Change in Oxidative Stress as Measured by Urine Levels of F2-isoprostanes	6 weeks		ng F2 isoprostane/mg creatinine	MEAN
PRIMARY	Change in Albuminuria	6 weeks		mg albumin/g creatinine	MEAN
SECONDARY	Change in Serum Potassium	6 weeks		mEq/L	MEAN
SECONDARY	Change in Serum Creatinine (Baseline - Post-medication)	6 weeks		mg/dL	MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Difference in 24 Hour Ambulatory Systolic Blood Pressure	Spironolactone Exposure	7.7	Standard Deviation 18.4	mm Hg
Difference in 24 Hour Ambulatory Systolic Blood Pressure	Amiloride Exposure	12.5	Standard Deviation 23.3	mm Hg
Change in Oxidative Stress as Measured by Urine Levels of F2-isoprostanes	Spironolactone	-2.77	Standard Deviation 6.3	ng F2 isoprostane/mg creatinine
Change in Oxidative Stress as Measured by Urine Levels of F2-isoprostanes	Amiloride	-0.17	Standard Deviation 0.2	ng F2 isoprostane/mg creatinine
Change in Albuminuria	Spironolactone	129	Standard Deviation 326	mg albumin/g creatinine
Change in Albuminuria	Amiloride	285	Standard Deviation 565	mg albumin/g creatinine
Change in Serum Potassium	Spironolactone	0.4	Standard Deviation 1.5	mEq/L
Change in Serum Potassium	Amiloride	-0.5	Standard Deviation 0.6	mEq/L
Change in Serum Creatinine (Baseline - Post-medication)	Spironolactone	0.2	Standard Deviation 0.8	mg/dL
Change in Serum Creatinine (Baseline - Post-medication)	Amiloride	-0.1	Standard Deviation 0.3	mg/dL

Source ClinicalTrials.gov

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
First Intervention (6 Weeks)	STARTED	Spironolactone First, Then Amiloride	13
First Intervention (6 Weeks)	STARTED	Amiloride First, Then Spironolactone	6
First Intervention (6 Weeks)	COMPLETED	Spironolactone First, Then Amiloride	12
First Intervention (6 Weeks)	COMPLETED	Amiloride First, Then Spironolactone	6
First Intervention (6 Weeks)	NOT COMPLETED	Spironolactone First, Then Amiloride	1
First Intervention (6 Weeks)	NOT COMPLETED	Amiloride First, Then Spironolactone	0
Washout (1 Month)	STARTED	Spironolactone First, Then Amiloride	12
Washout (1 Month)	STARTED	Amiloride First, Then Spironolactone	6
Washout (1 Month)	COMPLETED	Spironolactone First, Then Amiloride	12
Washout (1 Month)	COMPLETED	Amiloride First, Then Spironolactone	6

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hyperkalemia	Renal and urinary disorders	Spironolactone First, Then Amiloride	0	13	0
other	Hyperkalemia	Renal and urinary disorders	Amiloride First, Then Spironolactone	0	6	0
other	Hyperkalemia	Renal and urinary disorders	Spironolactone Second Intervention	1	6	1
other	Hyperkalemia	Renal and urinary disorders	Amiloride Second Intervention	0	12	0

Source ClinicalTrials.gov

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Spironolactone First, Then Amiloride	0	13
Total, all-cause mortality	Amiloride First, Then Spironolactone	0	6
Total, all-cause mortality	Spironolactone Second Intervention	0	6
Total, all-cause mortality	Amiloride Second Intervention	0	12
Total, other adverse events	Spironolactone First, Then Amiloride	0	13
Total, other adverse events	Amiloride First, Then Spironolactone	0	6
Total, other adverse events	Spironolactone Second Intervention	1	6
Total, other adverse events	Amiloride Second Intervention	0	12
Total, serious adverse events	Spironolactone First, Then Amiloride	0	13
Total, serious adverse events	Amiloride First, Then Spironolactone	0	6

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

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