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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aliskiren | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aliskiren 300mg/d | Drug | Aliskiren 300mg/d v.s. placebo for 12wk |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of systolic blood pressure | 12 wk after randomization | |
| Reduction of proteinuria | 12 wk after randomization | |
| Change in GFR/mo |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Krissanapong Manotham, Dr | Contact | 662 3539799 | 2501 | kmanotham@hotmail.com |
| Tanaporn Ratanasuwan, Dr | Contact | 662 3539799 | 9722 | tratanas@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lerdsin General Hospital | Bangkok | 10500 | Thailand |
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| 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 |
| ID | Term |
|---|---|
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C446481 | aliskiren |
| D013619 | Tacrine |
| ID | Term |
|---|---|
| D000609 | Aminoacridines |
| D000166 | Acridines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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