Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy

Study Overview
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Brief Summary
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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 it was used alone or in combination. Aliskiren is a direct renin inhibitor (DRI) that has shown renal benefits and safety when combined with ARB. However, to date, the safety of add on aliskiren to the combination treatment of ACEI and ARB in diabetic nephropathy patients remains to elucidate.

Official Title
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Safety of Add on Aliskiren to ACEI and ARB Treatment in Type 2 Diabetes With Nephropathy

Conditions
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Type 2 Diabetes With Nephropathy

Intervention / Treatment
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* Drug: Aliskiren 300mg/d


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Aliskiren<br> | Drug: Aliskiren 300mg/d<br>* Aliskiren 300mg/d v.s. placebo for 12wk<br>* Other names: Rasilez (Thailand);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess short-term safety of the combination of aliskiren 300 mg/valsartan 160 mg /enalapril 20 mg in patients with diabetic nephropathy |  | 12 wk after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of systolic blood pressure |  | 12 wk after randomization | 
| Reduction of proteinuria |  | 12 wk after randomization | 
| Change in GFR/mo |  | 12 wk after randomization | 
| Change of Serum prorenin level compare to baseline |  | 12 wk after randomization | 
| Change of Urinary TGFb1 compare to baseline |  | 12 wk after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACEI, ARB, DN, aliskiren, proteinuria