Trial Outcomes & Findings for Shiga Microalbuminuria Reduction Trial-2 (NCT NCT01461499)
NCT ID: NCT01461499
Last Updated: 2018-02-19
Results Overview
Change in the urinary albumin to creatinine ratio (UACR) from the baseline
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
237 participants
Primary outcome timeframe
baseline and 24 weeks
Results posted on
2018-02-19
Participant Flow
Participant milestones
| Measure |
Direct Renin Inhibitor
Aliskiren:
A total of 119 patients were randomly assigned to receive direct renin inhibitor. Eight patients dropped out during the observation period and a total of 111 patients were studied in this group.
|
Angiotensin Receptor Blockers
A total of 118 patients were randomly assigned to receive angiotensin receptor blockers. Four patients dropped out during the observation period and a total of 114 patients were studied in this group.
|
|---|---|---|
|
Overall Study
STARTED
|
119
|
118
|
|
Overall Study
COMPLETED
|
111
|
114
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Shiga Microalbuminuria Reduction Trial-2
Baseline characteristics by cohort
| Measure |
Direct Renin Inhibitor
n=111 Participants
Aliskiren: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP \< 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
|
Angiotensin Receptor Blockers
n=114 Participants
any angiotensin receptor blockers: The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP \< 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
|
Total
n=225 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
|
55 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
56 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
113 Participants
n=5 Participants
|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 8.4 • n=7 Participants
|
63.0 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
77 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
111 participants
n=5 Participants
|
114 participants
n=7 Participants
|
225 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline and 24 weeksChange in the urinary albumin to creatinine ratio (UACR) from the baseline
Outcome measures
| Measure |
Direct Renin Inhibitor
n=111 Participants
Aliskiren: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP \< 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
A total of 378 patients were enrolled for screening, and 141 were not meeting inclusion criteria. Thus, 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Eight patients dropped out during the observation period and a total of 111 patients were studied in this group.
|
Angiotensin Receptor Blockers
n=114 Participants
any angiotensin receptor blockers: The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP \< 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
A total of 378 patients were enrolled for screening, and 141 were not meeting inclusion criteria. Thus, 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Four patients dropped out during the observation period and a total of 114 patients were studied in this group.
|
|---|---|---|
|
Reduction in Albuminuria
|
-5.5 percentage of UACR change
Interval -13.5 to 2.5
|
-6.7 percentage of UACR change
Interval -20.3 to 0.6
|
SECONDARY outcome
Timeframe: baseline and 24 weeksChange in the urinaryurinary angiotensinogen level from the baseline
Outcome measures
| Measure |
Direct Renin Inhibitor
n=111 Participants
Aliskiren: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP \< 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
A total of 378 patients were enrolled for screening, and 141 were not meeting inclusion criteria. Thus, 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Eight patients dropped out during the observation period and a total of 111 patients were studied in this group.
|
Angiotensin Receptor Blockers
n=114 Participants
any angiotensin receptor blockers: The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP \< 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
A total of 378 patients were enrolled for screening, and 141 were not meeting inclusion criteria. Thus, 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Four patients dropped out during the observation period and a total of 114 patients were studied in this group.
|
|---|---|---|
|
Change in the Urinary Angiotensinogen Level
|
-1.7 percentage of change UATGCR
Interval -10.4 to 7.9
|
-5.4 percentage of change UATGCR
Interval -22.1 to 1.6
|
SECONDARY outcome
Timeframe: baseline and 24 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and 24 weeksOutcome measures
Outcome data not reported
Adverse Events
Direct Renin Inhibitor
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Angiotensin Receptor Blockers
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Direct Renin Inhibitor
n=119 participants at risk
Aliskiren: The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP \< 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
378 patients were enrolled for screening, and 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Eight patients dropped out during the observation period and a total of 111 patients were studied in this group.
|
Angiotensin Receptor Blockers
n=118 participants at risk
any angiotensin receptor blockers: The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP \< 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
378 patients were enrolled for screening, and 237 were randomly assigned to receive either direct renin inhibitor (119) or angiotensin receptor blockers (118). Four patients dropped out during the observation period and a total of 114 patients were studied in this group.
|
|---|---|---|
|
Infections and infestations
pneumonia
|
1.7%
2/119 • Number of events 5
|
1.7%
2/118 • Number of events 6
|
Additional Information
Steering Committee: Takashi Uzu
Shiga University of Medical Science
Phone: 81-77-548-2222
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place