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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 recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2009 by Lerdsin General Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00949351
First Posted: July 30, 2009
Last Update Posted: July 30, 2009
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.
Information provided by:
Lerdsin General Hospital
  Purpose
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 Intervention Phase
Type 2 Diabetes With Nephropathy Drug: Aliskiren 300mg/d Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Lerdsin General Hospital:

Primary Outcome Measures:
  • 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:
  • Reduction of systolic blood pressure [ Time Frame: 12 wk after randomization ]
  • Reduction of proteinuria [ Time Frame: 12 wk after randomization ]
  • Change in GFR/mo [ Time Frame: 12 wk after randomization ]
  • Change of Serum prorenin level compare to baseline [ Time Frame: 12 wk after randomization ]
  • Change of Urinary TGFb1 compare to baseline [ Time Frame: 12 wk after randomization ]

Estimated Enrollment: 80
Study Start Date: September 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Aliskiren Drug: Aliskiren 300mg/d
Aliskiren 300mg/d v.s. placebo for 12wk
Other Name: Rasilez (Thailand)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00949351


Contacts
Contact: Krissanapong Manotham, Dr 662 3539799 ext 2501 kmanotham@hotmail.com
Contact: Tanaporn Ratanasuwan, Dr 662 3539799 ext 9722 tratanas@hotmail.com

Locations
Thailand
Lerdsin General Hospital Not yet recruiting
Bangkok, Thailand, 10500
Contact: Krissanapong Manotham, Dr    662 3539799 ext 2501    kmanotham@hotmail.com   
Contact: Tanaporn Ratanasuwan, Dr       tratanas@hotmail.com   
Principal Investigator: Krissanapong Manotham, Dr         
Sponsors and Collaborators
Lerdsin General Hospital
  More Information

Responsible Party: Division of Nephrology, Department of Medicine, Lerdsin General Hospital
ClinicalTrials.gov Identifier: NCT00949351     History of Changes
Other Study ID Numbers: Lerdsin 36/52
First Submitted: July 29, 2009
First Posted: July 30, 2009
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:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action