Trial Outcomes & Findings for Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Add-On (NCT NCT03597035)
NCT ID: NCT03597035
Last Updated: 2022-05-16
Results Overview
Change in left ventricular mass from baseline to 12 months.
TERMINATED
PHASE4
8 participants
Time 0: study baseline, beginning of treatment. Time 1: 12 months follow-up, end of treatment.
2022-05-16
Participant Flow
Single arm experimental study in 50 diabetic patients with chronic kidney disease and hyperkalemia. Spironolactone: The study participants will receive concomitant treatment with Veltassa 8.4 grams per day and Spironolactone 25 mg per day or maximum tolerated dose. If dictated by the potassium level
Participant milestones
| Measure |
Patiromer Add-On
Single arm experimental study in 50 diabetic patients with chronic kidney disease and hyperkalemia.
Spironolactone: The study participants will receive concomitant treatment with Veltassa 8.4 grams per day and Spironolactone 25 mg per day or maximum tolerated dose. If dictated by the potassium level, Veltassa can be increased to 16.8 grams per day.
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mineralocorticoid Receptor Antagonism Clinical Evaluation in Atherosclerosis Add-On
Baseline characteristics by cohort
| Measure |
Patiromer Add-On
n=8 Participants
Single arm experimental study in 50 diabetic patients with chronic kidney disease and hyperkalemia.
Spironolactone: The study participants will receive concomitant treatment with Veltassa 8.4 grams per day and Spironolactone 25 mg per day or maximum tolerated dose. If dictated by the potassium level, Veltassa can be increased to 16.8 grams per day.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time 0: study baseline, beginning of treatment. Time 1: 12 months follow-up, end of treatment.Population: Data not collected
Change in left ventricular mass from baseline to 12 months.
Outcome measures
Outcome data not reported
Adverse Events
Patiromer Add-On
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Sanjay Rajagopalan
University Hospitals Cleveland Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place