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

Lerdsin General Hospital

Status and phase

Unknown

Phase 4

Conditions

Type 2 Diabetes With Nephropathy

Treatments

Drug: Aliskiren 300mg/d

Study type

Interventional

Funder types

Other

Identifiers

NCT00949351

Lerdsin 36/52

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

30 to 70 years old

Volunteers

No Healthy Volunteers

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)