Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-25 @ 9:47 PM
Study NCT ID:
NCT00949351
Status:
UNKNOWN
Last Update Posted:
2009-07-30
First Post:
2009-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C446481', 'term': 'aliskiren'}, {'id': 'D013619', 'term': 'Tacrine'}], 'ancestors': [{'id': 'D000609', 'term': 'Aminoacridines'}, {'id': 'D000166', 'term': 'Acridines'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2010-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-07-29', 'studyFirstSubmitDate': '2009-07-29', 'studyFirstSubmitQcDate': '2009-07-29', 'lastUpdatePostDateStruct': {'date': '2009-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess short-term safety of the combination of aliskiren 300 mg/valsartan 160 mg /enalapril 20 mg in patients with diabetic nephropathy', 'timeFrame': '12 wk after randomization'}], 'secondaryOutcomes': [{'measure': 'Reduction of systolic blood pressure', 'timeFrame': '12 wk after randomization'}, {'measure': 'Reduction of proteinuria', 'timeFrame': '12 wk after randomization'}, {'measure': 'Change in GFR/mo', 'timeFrame': '12 wk after randomization'}, {'measure': 'Change of Serum prorenin level compare to baseline', 'timeFrame': '12 wk after randomization'}, {'measure': 'Change of Urinary TGFb1 compare to baseline', 'timeFrame': '12 wk after randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ACEI, ARB, DN, aliskiren, proteinuria'], 'conditions': ['Type 2 Diabetes With Nephropathy']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type2 diabetes patients\n* Age \\<30yrs-70yrs\\>\n* Overt proteinuria (Urinary protein creatinine ratio \\> 200mg/g 2 times or more during past 6 Mo)\n* Scr \\< 2.5 mg/dL\n* HbA1C \\< 7.5\n* Systolic blood pressure \\> 160 mmHg without antihypertensive drugs or \\> 140 with antihypertensive drug\n* No history of previous cardiovascular event (Stroke, Myocardial infarction, unstable angina, hospitalization, surgical correction PVD or PVD with claudication)\n* No hospitalization within 1 yr except for elective surgery\n\nExclusion Criteria:\n\n* Physical examination found or suspected serious co-morbid (AF, carotid bruit, structural heart disease, cirrhosis and decompensate liver disease)\n* Non adherence to protocol\n* Intolerable to ACEI or ARB during run-in\n* Abnormal liver function test at the run-in period\n* Rapid declining renal function (SCr increase \\> 40%) during run-in\n* Hyperkalemia (serum K \\> 5.5 mEq/L at randomization)\n* Malignancy detected o\n* SBP lower than 110 mmHg (at randomization)'}, 'identificationModule': {'nctId': 'NCT00949351', 'briefTitle': 'Safety of Add on Aliskiren to Angiotensin Converting Enzyme Inhibitor (ACEI) and Angiotensin I Receptor Blocker (ARB) Treatment in Type 2 Diabetes With Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Lerdsin General Hospital'}, 'officialTitle': 'Safety of Add on Aliskiren to ACEI and ARB Treatment in Type 2 Diabetes With Nephropathy', 'orgStudyIdInfo': {'id': 'Lerdsin 36/52'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Aliskiren', 'interventionNames': ['Drug: Aliskiren 300mg/d']}], 'interventions': [{'name': 'Aliskiren 300mg/d', 'type': 'DRUG', 'otherNames': ['Rasilez (Thailand)'], 'description': 'Aliskiren 300mg/d v.s. placebo for 12wk', 'armGroupLabels': ['Aliskiren']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10500', 'city': 'Bangkok', 'country': 'Thailand', 'contacts': [{'name': 'Krissanapong Manotham, Dr', 'role': 'CONTACT', 'email': 'kmanotham@hotmail.com', 'phone': '662 3539799', 'phoneExt': '2501'}, {'name': 'Tanaporn Ratanasuwan, Dr', 'role': 'CONTACT', 'email': 'tratanas@hotmail.com'}, {'name': 'Krissanapong Manotham, Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Lerdsin General Hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Krissanapong Manotham, Dr', 'role': 'CONTACT', 'email': 'kmanotham@hotmail.com', 'phone': '662 3539799', 'phoneExt': '2501'}, {'name': 'Tanaporn Ratanasuwan, Dr', 'role': 'CONTACT', 'email': 'tratanas@hotmail.com', 'phone': '662 3539799', 'phoneExt': '9722'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lerdsin General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Division of Nephrology, Department of Medicine', 'oldOrganization': 'Lerdsin General Hospital'}}}}