Trial Outcomes & Findings for Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease (NCT NCT02497300)
NCT ID: NCT02497300
Last Updated: 2022-12-21
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
6 weeks
Results posted on
2022-12-21
Participant Flow
Participant milestones
| Measure |
Spironolactone First, Then Amiloride
Participants will be randomized to spironolactone 25mg daily for the 1st treatment period of 6 weeks
Spironolactone
|
Amiloride First, Then Spironolactone
Participants will be randomized to amiloride 5mg daily for the 1st treatment period of 6 weeks
Amiloride
|
|---|---|---|
|
First Intervention (6 Weeks)
STARTED
|
13
|
6
|
|
First Intervention (6 Weeks)
COMPLETED
|
12
|
6
|
|
First Intervention (6 Weeks)
NOT COMPLETED
|
1
|
0
|
|
Washout (1 Month)
STARTED
|
12
|
6
|
|
Washout (1 Month)
COMPLETED
|
12
|
6
|
|
Washout (1 Month)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (6 Weeks)
STARTED
|
12
|
6
|
|
Second Intervention (6 Weeks)
COMPLETED
|
10
|
5
|
|
Second Intervention (6 Weeks)
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Vascular Effects of Mineralocorticoid Receptor Antagonism in Kidney Disease
Baseline characteristics by cohort
| Measure |
Spironolactone First, Then Amiloride
n=13 Participants
Randomized to 25mg daily of spironolactone as the first study medication.
|
Amiloride First, Then Spironolactone
n=6 Participants
Randomized to 5mg daily of amiloride as the first study medication.
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
47.5 years
STANDARD_DEVIATION 17.4 • n=7 Participants
|
47.6 years
STANDARD_DEVIATION 15.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
6 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: Some participants had missing or incomplete 24 hour ambulatory blood pressure monitoring
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.
Outcome measures
| Measure |
Spironolactone Exposure
n=16 Participants
After 6 weeks of spironolactone 25mg daily (combined first or second treatment period)
|
Amiloride Exposure
n=16 Participants
After 6 weeks of amiloride 5mg daily (combined first or second treatment period)
|
|---|---|---|
|
Difference in 24 Hour Ambulatory Systolic Blood Pressure
|
7.7 mm Hg
Standard Deviation 18.4
|
12.5 mm Hg
Standard Deviation 23.3
|
PRIMARY outcome
Timeframe: 6 weeksDifference in level of urine 8-iso-prostaglandin-F2-alpha per mg of creatinine levels between 6 weeks of spironolactone vs. 6 weeks of amiloride.
Outcome measures
| Measure |
Spironolactone Exposure
n=10 Participants
After 6 weeks of spironolactone 25mg daily (combined first or second treatment period)
|
Amiloride Exposure
n=5 Participants
After 6 weeks of amiloride 5mg daily (combined first or second treatment period)
|
|---|---|---|
|
Change in Oxidative Stress as Measured by Urine Levels of F2-isoprostanes
|
-2.77 ng F2 isoprostane/mg creatinine
Standard Deviation 6.3
|
-0.17 ng F2 isoprostane/mg creatinine
Standard Deviation 0.2
|
PRIMARY outcome
Timeframe: 6 weeksChange of the urine albumin-to-creatinine ratio (baseline - post-study med) after 6 weeks of spironolactone vs. 6 weeks of amiloride.
Outcome measures
| Measure |
Spironolactone Exposure
n=10 Participants
After 6 weeks of spironolactone 25mg daily (combined first or second treatment period)
|
Amiloride Exposure
n=5 Participants
After 6 weeks of amiloride 5mg daily (combined first or second treatment period)
|
|---|---|---|
|
Change in Albuminuria
|
129 mg albumin/g creatinine
Standard Deviation 326
|
285 mg albumin/g creatinine
Standard Deviation 565
|
SECONDARY outcome
Timeframe: 6 weeksDifference in serum potassium levels (baseline - post-medication) after 6 weeks of spironolactone vs. 6 weeks of amiloride.
Outcome measures
| Measure |
Spironolactone Exposure
n=10 Participants
After 6 weeks of spironolactone 25mg daily (combined first or second treatment period)
|
Amiloride Exposure
n=5 Participants
After 6 weeks of amiloride 5mg daily (combined first or second treatment period)
|
|---|---|---|
|
Change in Serum Potassium
|
0.4 mEq/L
Standard Deviation 1.5
|
-0.5 mEq/L
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 6 weeksDifference in serum creatinine (baseline - post-medication) after 6 weeks of spironolactone vs. 6 weeks of amiloride.
Outcome measures
| Measure |
Spironolactone Exposure
n=10 Participants
After 6 weeks of spironolactone 25mg daily (combined first or second treatment period)
|
Amiloride Exposure
n=5 Participants
After 6 weeks of amiloride 5mg daily (combined first or second treatment period)
|
|---|---|---|
|
Change in Serum Creatinine (Baseline - Post-medication)
|
0.2 mg/dL
Standard Deviation 0.8
|
-0.1 mg/dL
Standard Deviation 0.3
|
Adverse Events
Spironolactone First, Then Amiloride
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Amiloride First, Then Spironolactone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Spironolactone Second Intervention
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Amiloride Second Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Spironolactone First, Then Amiloride
n=13 participants at risk
Randomized to 25mg daily of spironolactone as the first study medication.
|
Amiloride First, Then Spironolactone
n=6 participants at risk
Randomized to amiloride 5mg daily as the first study medication
|
Spironolactone Second Intervention
n=6 participants at risk
Received 25mg spironolactone after 4 week washout
|
Amiloride Second Intervention
n=12 participants at risk
Received 5mg amiloride after 4 week washout
|
|---|---|---|---|---|
|
Renal and urinary disorders
Hyperkalemia
|
0.00%
0/13 • 16 weeks
|
0.00%
0/6 • 16 weeks
|
16.7%
1/6 • Number of events 1 • 16 weeks
|
0.00%
0/12 • 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place