Trial Outcomes & Findings for Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD (NCT NCT02975505)
NCT ID: NCT02975505
Last Updated: 2025-02-17
Results Overview
Achieved clinic SBP at month 12
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
108 participants
Primary outcome timeframe
At month 12
Results posted on
2025-02-17
Participant Flow
Participant milestones
| Measure |
Usual SBP Target
Target Systolic Home Blood Pressure 130-140 mm Hg
|
Strict SBP Target
Target Systolic Home Blood Pressure \<120 mm Hg
Strict blood pressure control: Systolic Blood Pressure Target \< 120 mm Hg (measured at home)
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
66
|
|
Overall Study
Month 4
|
38
|
61
|
|
Overall Study
COMPLETED
|
34
|
59
|
|
Overall Study
NOT COMPLETED
|
8
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot to Examine Risk and Feasibility of Remote Management of BP From CKD Through ESRD
Baseline characteristics by cohort
| Measure |
Usual SBP Target
n=42 Participants
Target Systolic Home Blood Pressure 130-140 mm Hg
|
Strict SBP Target
n=66 Participants
Target Systolic Home Blood Pressure \<120 mm Hg
Strict blood pressure control: Systolic Blood Pressure Target \< 120 mm Hg (measured at home)
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
n=99 Participants
|
53 years
n=107 Participants
|
56 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=99 Participants
|
54 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian or Pacific Islander
|
14 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native American
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
21 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
47 Participants
n=206 Participants
|
|
Clinic systolic blood pressure
|
135 mmHg
n=99 Participants
|
135 mmHg
n=107 Participants
|
135 mmHg
n=206 Participants
|
|
Clinic diastolic blood pressure
|
79 mmHg
n=99 Participants
|
81 mmHg
n=107 Participants
|
79 mmHg
n=206 Participants
|
|
Diabetes
|
14 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Baseline eGFR
|
24 mL/min/1.73 m2
n=99 Participants
|
24 mL/min/1.73 m2
n=107 Participants
|
24 mL/min/1.73 m2
n=206 Participants
|
|
Urine protein/creatinine ratio
|
1 g/g
n=99 Participants
|
1 g/g
n=107 Participants
|
1 g/g
n=206 Participants
|
|
History of heart failure
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
History of acute coronary syndrome
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
History of Smoking
Never
|
23 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
History of Smoking
Former
|
18 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
History of Smoking
Current
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Insurance
Medicare
|
20 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Insurance
Medicaid
|
3 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Insurance
Private
|
19 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At month 12Achieved clinic SBP at month 12
Outcome measures
| Measure |
Usual SBP Target
n=42 Participants
Target Systolic Home Blood Pressure 130-140 mm Hg
|
Strict SBP Target
n=66 Participants
Target Systolic Home Blood Pressure \<120 mm Hg
Strict blood pressure control: Systolic Blood Pressure Target \< 120 mm Hg (measured at home)
|
|---|---|---|
|
Achieved Clinic Systolic Blood Pressure
|
138.2 mmHg
Standard Deviation 5.3
|
124.7 mmHg
Standard Deviation 3.8
|
PRIMARY outcome
Timeframe: Months 4-12Population: Difference is measured between months 4-12
Incorporating achieved mean SBP data between months 4-12
Outcome measures
| Measure |
Usual SBP Target
n=108 Participants
Target Systolic Home Blood Pressure 130-140 mm Hg
|
Strict SBP Target
Target Systolic Home Blood Pressure \<120 mm Hg
Strict blood pressure control: Systolic Blood Pressure Target \< 120 mm Hg (measured at home)
|
|---|---|---|
|
Difference in Clinic SBP Between the Two Arms
|
11.7 mmHg
Interval 7.5 to 16.0
|
—
|
PRIMARY outcome
Timeframe: Months 0-12Potassium \>=6 or self-reported syncope or falls or discharge diagnosis of acute kidney injury from emergency room or hospitalization
Outcome measures
| Measure |
Usual SBP Target
n=66 Participants
Target Systolic Home Blood Pressure 130-140 mm Hg
|
Strict SBP Target
n=42 Participants
Target Systolic Home Blood Pressure \<120 mm Hg
Strict blood pressure control: Systolic Blood Pressure Target \< 120 mm Hg (measured at home)
|
|---|---|---|
|
Hyperkalemia, Syncope, Falls, ESKD
Hyperkalemia
|
2 Participants
|
2 Participants
|
|
Hyperkalemia, Syncope, Falls, ESKD
Syncope
|
1 Participants
|
3 Participants
|
|
Hyperkalemia, Syncope, Falls, ESKD
Falls
|
9 Participants
|
7 Participants
|
|
Hyperkalemia, Syncope, Falls, ESKD
Dialysis or (re)-transplant
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From baseline entry through the end of Year 3 of studyPopulation: Number of participants screened to enroll 1 participant
This is the number of potential participants screened as eligible to the number who agree to enroll
Outcome measures
| Measure |
Usual SBP Target
n=724 Participants
Target Systolic Home Blood Pressure 130-140 mm Hg
|
Strict SBP Target
Target Systolic Home Blood Pressure \<120 mm Hg
Strict blood pressure control: Systolic Blood Pressure Target \< 120 mm Hg (measured at home)
|
|---|---|---|
|
Screening to Enrollment Ratio
|
108 participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Between month 4 after baseline and year 4 of studyClinic
Outcome measures
| Measure |
Usual SBP Target
n=108 Participants
Target Systolic Home Blood Pressure 130-140 mm Hg
|
Strict SBP Target
Target Systolic Home Blood Pressure \<120 mm Hg
Strict blood pressure control: Systolic Blood Pressure Target \< 120 mm Hg (measured at home)
|
|---|---|---|
|
Difference in Achieved SBP
|
12.5 mmHg
Interval 9.0 to 16.1
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Between month 4 after baseline and year 4 of studyPotassium \>=6 or self-reported syncope or falls or discharge diagnosis or need of dialysis or retransplantation
Outcome measures
| Measure |
Usual SBP Target
n=66 Participants
Target Systolic Home Blood Pressure 130-140 mm Hg
|
Strict SBP Target
n=42 Participants
Target Systolic Home Blood Pressure \<120 mm Hg
Strict blood pressure control: Systolic Blood Pressure Target \< 120 mm Hg (measured at home)
|
|---|---|---|
|
Hyperkalemia, Syncope, Falls, ESKD
Hyperkalemia
|
2 Participants
|
2 Participants
|
|
Hyperkalemia, Syncope, Falls, ESKD
Syncope
|
1 Participants
|
4 Participants
|
|
Hyperkalemia, Syncope, Falls, ESKD
Falls
|
11 Participants
|
8 Participants
|
|
Hyperkalemia, Syncope, Falls, ESKD
Dialysis or (re)-transplant
|
14 Participants
|
4 Participants
|
Adverse Events
Strict SBP Target
Serious events: 30 serious events
Other events: 18 other events
Deaths: 5 deaths
Usual SBP Target
Serious events: 22 serious events
Other events: 10 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Strict SBP Target
n=66 participants at risk
Target Systolic Home Blood Pressure \<120 mm Hg
Strict blood pressure control: Systolic Blood Pressure Target \< 120 mm Hg (measured at home)
|
Usual SBP Target
n=42 participants at risk
Target Systolic Home Blood Pressure 130-140 mm Hg
|
|---|---|---|
|
Investigations
All-cause hospitalization
|
45.5%
30/66 • Between baseline and year 4 of study
The study team collected adverse event information from the participants weekly.
|
52.4%
22/42 • Between baseline and year 4 of study
The study team collected adverse event information from the participants weekly.
|
Other adverse events
| Measure |
Strict SBP Target
n=66 participants at risk
Target Systolic Home Blood Pressure \<120 mm Hg
Strict blood pressure control: Systolic Blood Pressure Target \< 120 mm Hg (measured at home)
|
Usual SBP Target
n=42 participants at risk
Target Systolic Home Blood Pressure 130-140 mm Hg
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury or ER visit
|
27.3%
18/66 • Between baseline and year 4 of study
The study team collected adverse event information from the participants weekly.
|
23.8%
10/42 • Between baseline and year 4 of study
The study team collected adverse event information from the participants weekly.
|
Additional Information
Dr. Elaine Ku
University of California, San Francisco Division of Nephrology
Phone: 415-502-7760
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place