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

• Status: Unknown status
• Trial end date: 2010-09-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lerdsin General Hospital
• Treatments: Angiotensin-Converting Enzyme Inhibitors

Criteria

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)