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

Phase 4

• Conditions: Type 2 Diabetes With Nephropathy
• Interventions: Drug: Aliskiren 300mg/d

• Registration Number: NCT00949351
• Lead Sponsor: Lerdsin General Hospital

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-07
• Study First Submitted: 2009-07-29
• Study First Submitted QC: 2009-07-29
• Last Update Submitted: 2009-07-29
• Study First Posted: 2009-07-30
• Last Update Posted: 2009-07-30
• Study Start: 2009-09
• Primary Completion: 2010-07
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aliskiren	Aliskiren 300mg/d	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Lerdsin General Hospital; 🇹🇭 Bangkok, Thailand