Trial Outcomes & Findings for Effect of Renin-angiotensin-system Blockade on Urinary Free Light Chains in Patients With Type 2 Diabetes Mellitus (NCT NCT02046395)
NCT ID: NCT02046395
Last Updated: 2023-08-21
Results Overview
Kidney function will be assessed throughout the study to assess changes in function prior to the washout of ACE/ARB medication and reintroduction of the ACE/ARB medication.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
28 participants
Primary outcome timeframe
Visit 1 (Baseline), Visit 3 (Day 60)
Results posted on
2023-08-21
Participant Flow
Participant milestones
| Measure |
Alternate Antihypertensive Arm
In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure. The goal for their blood pressure will be set at \< 140/90 mm/Hg. The washout period will last for four weeks at the end of which the patient will enter the test period.
amlodipine, hydralazine, terazosin or hydrochlorothiazide: In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure.
|
|---|---|
|
Pre RAS Blockade Washout Period
STARTED
|
28
|
|
Pre RAS Blockade Washout Period
COMPLETED
|
28
|
|
Pre RAS Blockade Washout Period
NOT COMPLETED
|
0
|
|
RAS Blockade Washout Period
STARTED
|
28
|
|
RAS Blockade Washout Period
COMPLETED
|
28
|
|
RAS Blockade Washout Period
NOT COMPLETED
|
0
|
|
Post RAS Blockade Washout Period
STARTED
|
28
|
|
Post RAS Blockade Washout Period
COMPLETED
|
27
|
|
Post RAS Blockade Washout Period
NOT COMPLETED
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Renin-angiotensin-system Blockade on Urinary Free Light Chains in Patients With Type 2 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Alternate Antihypertensive Arm
n=28 Participants
In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure. The goal for their blood pressure will be set at \< 140/90 mm/Hg. The washout period will last for four weeks at the end of which the patient will enter the test period.
amlodipine, hydralazine, terazosin or hydrochlorothiazide: In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
59.61 years
STANDARD_DEVIATION 9.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
|
Creatinine
|
1.01 mg/dL
STANDARD_DEVIATION 0.23 • n=5 Participants
|
|
eGFR
|
72.44 mL/min/1.73m^2
STANDARD_DEVIATION 21.8 • n=5 Participants
|
|
Hemoglobin A1c
|
7.53 Percent
STANDARD_DEVIATION 1.07 • n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (Baseline), Visit 3 (Day 60)Population: Measurement was done for the change between Visit 1 (screening visit and the beginning of the washout period may be combined -day -30), and Visit 3 (day 30 of the test period).
Kidney function will be assessed throughout the study to assess changes in function prior to the washout of ACE/ARB medication and reintroduction of the ACE/ARB medication.
Outcome measures
| Measure |
Alternate Antihypertensive Arm
n=28 Participants
In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure. The goal for their blood pressure will be set at \< 140/90 mm/Hg. The washout period will last for four weeks at the end of which the patient will enter the test period.
amlodipine, hydralazine, terazosin or hydrochlorothiazide: In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure.
|
|---|---|
|
Change in Urine Microalbumin Creatinine Ratio
|
15 mg/g
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: Visit 1 (Baseline), Visit 3 (Day 60)Population: Measurement was done for the change between Visit 1 (screening visit and the beginning of the washout period may be combined -day -30), and Visit 3 (day 30 of the test period).
In relation to kidney function and washout/reintroduction of ACE/ARB medication the level of urinary free light chains will be assessed.
Outcome measures
| Measure |
Alternate Antihypertensive Arm
n=28 Participants
In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure. The goal for their blood pressure will be set at \< 140/90 mm/Hg. The washout period will last for four weeks at the end of which the patient will enter the test period.
amlodipine, hydralazine, terazosin or hydrochlorothiazide: In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure.
|
|---|---|
|
Change in the Level of Urinary Free Light Chains
|
1.14 mg/g
Standard Deviation 2.03
|
Adverse Events
Alternate Antihypertensive (Pre RAS Blockade Washout Period)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alternate Antihypertensive (RAS Blockade Washout Period)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alternate Antihypertensive (Post RAS Blockade Washout Period)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place