Back to resultsSafety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy
Primary Purpose
Type 2 Diabetes With Nephropathy
Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Aliskiren 300mg/d
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes With Nephropathy focused on measuring ACEI, ARB, DN, aliskiren, proteinuria
Eligibility 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)
Sites / Locations
- Lerdsin General Hospital
Arms of the Study
Arm 1
Arm Type
Placebo Comparator
Arm Label
Aliskiren
Arm Description
Outcomes
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
Secondary Outcome Measures
Reduction of systolic blood pressure
Reduction of proteinuria
Change in GFR/mo
Change of Serum prorenin level compare to baseline
Change of Urinary TGFb1 compare to baseline
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00949351
Brief Title
Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy
Official Title
Safety of Add on Aliskiren to ACEI and ARB Treatment in Type 2 Diabetes With Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2010 (Anticipated)
Study Completion Date
September 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Lerdsin General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes With Nephropathy
Keywords
ACEI, ARB, DN, aliskiren, proteinuria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aliskiren
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Aliskiren 300mg/d
Other Intervention Name(s)
Rasilez (Thailand)
Intervention Description
Aliskiren 300mg/d v.s. placebo for 12wk
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Reduction of systolic blood pressure
Time Frame
12 wk after randomization
Title
Reduction of proteinuria
Time Frame
12 wk after randomization
Title
Change in GFR/mo
Time Frame
12 wk after randomization
Title
Change of Serum prorenin level compare to baseline
Time Frame
12 wk after randomization
Title
Change of Urinary TGFb1 compare to baseline
Time Frame
12 wk after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Krissanapong Manotham, Dr
Phone
662 3539799
Ext
2501
Email
kmanotham@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tanaporn Ratanasuwan, Dr
Phone
662 3539799
Ext
9722
Email
tratanas@hotmail.com
Facility Information:
Facility Name
Lerdsin General Hospital
City
Bangkok
ZIP/Postal Code
10500
Country
Thailand
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krissanapong Manotham, Dr
Phone
662 3539799
Ext
2501
Email
kmanotham@hotmail.com
First Name & Middle Initial & Last Name & Degree
Tanaporn Ratanasuwan, Dr
Email
tratanas@hotmail.com
First Name & Middle Initial & Last Name & Degree
Krissanapong Manotham, Dr
12. IPD Sharing Statement
Learn more about this trial
Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy
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