Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy
Information source: Lerdsin General Hospital
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Type 2 Diabetes With Nephropathy
Intervention: Aliskiren 300mg/d (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Lerdsin General Hospital Overall contact:
Krissanapong Manotham, Dr, Phone: 662 3539799, Ext: 2501, Email: kmanotham@hotmail.com
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.
Clinical Details
Official title: Safety of Add on Aliskiren to ACEI and ARB Treatment in Type 2 Diabetes With Nephropathy
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety Study
Primary outcome: Assess short-term safety of the combination of aliskiren 300 mg/valsartan 160 mg /enalapril 20 mg in patients with diabetic nephropathy
Secondary outcome: Reduction of systolic blood pressureReduction of proteinuria Change in GFR/mo Change of Serum prorenin level compare to baseline Change of Urinary TGFb1 compare to baseline
Eligibility
Minimum age: 30 Years.
Maximum age: 70 Years.
Gender(s): Both.
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)
Locations and Contacts
Krissanapong Manotham, Dr, Phone: 662 3539799, Ext: 2501, Email: kmanotham@hotmail.com
Lerdsin General Hospital, Bangkok 10500, Thailand
Additional Information
Starting date: September 2009
Ending date: September 2010
Last updated: July 29, 2009
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