Status:
UNKNOWN
Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy
Lead Sponsor:
Lerdsin General Hospital
Conditions:
Type 2 Diabetes With Nephropathy
Eligibility:
All Genders
30-70 years
Phase:
PHASE4
Brief Summary
Activation of renin-angiotensin plays a crucial role diabetic nephropathy. Angiotensin converting enzyme inhibitor (ACEI) and Angiotensin I receptor blocker (ARB) has been shown renoprotection whether...
Eligibility Criteria
Inclusion
- Type2 diabetes patients
- Age \<30yrs-70yrs\>
- Overt proteinuria (Urinary protein creatinine ratio \> 200mg/g 2 times or more during past 6 Mo)
- Scr \< 2.5 mg/dL
- HbA1C \< 7.5
- Systolic blood pressure \> 160 mmHg without antihypertensive drugs or \> 140 with antihypertensive drug
- No history of previous cardiovascular event (Stroke, Myocardial infarction, unstable angina, hospitalization, surgical correction PVD or PVD with claudication)
- No hospitalization within 1 yr except for elective surgery
Exclusion
- Physical examination found or suspected serious co-morbid (AF, carotid bruit, structural heart disease, cirrhosis and decompensate liver disease)
- Non adherence to protocol
- Intolerable to ACEI or ARB during run-in
- Abnormal liver function test at the run-in period
- Rapid declining renal function (SCr increase \> 40%) during run-in
- Hyperkalemia (serum K \> 5.5 mEq/L at randomization)
- Malignancy detected o
- SBP lower than 110 mmHg (at randomization)
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00949351
Start Date
September 1 2009
End Date
September 1 2010
Last Update
July 30 2009
Active Locations (1)
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1
Lerdsin General Hospital
Bangkok, Thailand, 10500