Type 2 Diabetes With Nephropathy Clinical Trial
Official title:
Safety of Add on Aliskiren to ACEI and ARB Treatment in Type 2 Diabetes With Nephropathy
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.
| Status | Not yet recruiting |
| Enrollment | 80 |
| Est. completion date | September 2010 |
| Est. primary completion date | July 2010 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 70 Years |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Lerdsin General Hospital | Bangkok |
| Lead Sponsor | Collaborator |
|---|---|
| Lerdsin General Hospital |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | Reduction of systolic blood pressure | 12 wk after randomization | No | |
| Secondary | Reduction of proteinuria | 12 wk after randomization | No | |
| Secondary | Change in GFR/mo | 12 wk after randomization | Yes | |
| Secondary | Change of Serum prorenin level compare to baseline | 12 wk after randomization | No | |
| Secondary | Change of Urinary TGFb1 compare to baseline | 12 wk after randomization | No |