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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00949351
Recruitment Status : Unknown
Verified July 2009 by Lerdsin General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 30, 2009
Last Update Posted : July 30, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes With Nephropathy Drug: Aliskiren 300mg/d Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Safety of Add on Aliskiren to ACEI and ARB Treatment in Type 2 Diabetes With Nephropathy
Study Start Date : September 2009
Estimated Primary Completion Date : July 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Aliskiren

Arm Intervention/treatment
Placebo Comparator: Aliskiren Drug: Aliskiren 300mg/d
Aliskiren 300mg/d v.s. placebo for 12wk
Other Name: Rasilez (Thailand)

Primary Outcome Measures :
  1. Assess short-term safety of the combination of aliskiren 300 mg/valsartan 160 mg /enalapril 20 mg in patients with diabetic nephropathy [ Time Frame: 12 wk after randomization ]

Secondary Outcome Measures :
  1. Reduction of systolic blood pressure [ Time Frame: 12 wk after randomization ]
  2. Reduction of proteinuria [ Time Frame: 12 wk after randomization ]
  3. Change in GFR/mo [ Time Frame: 12 wk after randomization ]
  4. Change of Serum prorenin level compare to baseline [ Time Frame: 12 wk after randomization ]
  5. Change of Urinary TGFb1 compare to baseline [ Time Frame: 12 wk after randomization ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00949351

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Contact: Krissanapong Manotham, Dr 662 3539799 ext 2501
Contact: Tanaporn Ratanasuwan, Dr 662 3539799 ext 9722

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Lerdsin General Hospital
Bangkok, Thailand, 10500
Contact: Krissanapong Manotham, Dr    662 3539799 ext 2501   
Contact: Tanaporn Ratanasuwan, Dr   
Principal Investigator: Krissanapong Manotham, Dr         
Sponsors and Collaborators
Lerdsin General Hospital
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Responsible Party: Division of Nephrology, Department of Medicine, Lerdsin General Hospital Identifier: NCT00949351    
Other Study ID Numbers: Lerdsin 36/52
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: July 30, 2009
Last Verified: July 2009
Keywords provided by Lerdsin General Hospital:
ACEI, ARB, DN, aliskiren, proteinuria
Additional relevant MeSH terms:
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Kidney Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases