Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-26 @ 12:40 AM
Study NCT ID:
NCT01541267
Status:
COMPLETED
Last Update Posted:
2012-02-29
First Post:
2012-02-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Various Types of the Renin-angiotensin-aldosterone System Blockade on Proteinuria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D011507', 'term': 'Proteinuria'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014555', 'term': 'Urination Disorders'}, {'id': 'D020924', 'term': 'Urological Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C446481', 'term': 'aliskiren'}, {'id': 'D000077545', 'term': 'Eplerenone'}, {'id': 'D000077333', 'term': 'Telmisartan'}], 'ancestors': [{'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-28', 'studyFirstSubmitDate': '2012-02-11', 'studyFirstSubmitQcDate': '2012-02-28', 'lastUpdatePostDateStruct': {'date': '2012-02-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in urinary albumin-to-creatinine ratio (UACR) between treatment arms', 'timeFrame': 'baseline and the end of 8 week treatments', 'description': 'changes of UACR'}], 'secondaryOutcomes': [{'measure': 'Difference in transforming growth factor beta (TGF-beta) between treatment arms', 'timeFrame': 'baseline and the end of 8 week treatments', 'description': 'Changes of urinary excretion of transforming growth factor beta (TGF-beta)'}, {'measure': 'Difference in serum potassium and creatinine between treatment arms', 'timeFrame': 'baseline and the end of 8 week treatments'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['aliskiren', 'eplerenon', 'telmisartan', 'direct renin inhibitor', 'ACE inhibitor', 'mineralocorticoid inhibitor', 'proteinuria', 'chronic kidney diseases', 'renin-angiotensin-aldosterone system'], 'conditions': ['Chronic Kidney Disease', 'Proteinuria']}, 'descriptionModule': {'briefSummary': 'The main purpose of the study is to compare the effects of three different types of RAAS blockade on 24 hours proteinuria in patients with non-diabetic chronic kidney disease.', 'detailedDescription': 'Pharmacological blockade of the renin-angiotensin-aldosterone system (RAAS) is the main target of therapy to reduces both proteinuria and the rate of decline of the glomerular filtration rate in non-diabetic chronic renal diseases. Despite recent progress, however, there is still no optimal therapy that can stop the progression of these nephropathies. Therefore, it is necessary to optimize such treatment for further improving renal outcome.\n\nThe aim of the present study was to compare the effects of three different types of RAAS blockade: (1) mineralocorticoid receptor blocker (MRB) + angiotensin receptor antagonist (ARA); (2) direct renin inhibitor (DRI) + ARA and (3) double maximal dose of ARA on 24 hours proteinuria in patients with non-diabetic chronic kidney disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-65 years\n* chronic non-diabetic proteinuric nephropathy\n* chronic kidney disease stage 1-3\n* stable proteinuria above 500 mg/24 hours\n* blood pressure above 125/75 mmHg and below 150/95 mmHg\n* no steroids or other immunosuppressive treatment for a minimum of six months before the study\n\nExclusion Criteria:\n\n* unstable coronary heart disease\n* decompensated congestive heart failure in the previous 6 months\n* episode of malignant hypertension or stroke in the history\n* diabetes\n* creatinine clearance below 30 ml/min\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01541267', 'briefTitle': 'The Effect of Various Types of the Renin-angiotensin-aldosterone System Blockade on Proteinuria', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Gdansk'}, 'officialTitle': 'The Effect of Various Types of the Renin-angiotensin-aldosterone System Blockade on Proteinuria in Chronic Non-diabetic Kidney Disease: a Double-blind Cross-over Randomised Controlled Study', 'orgStudyIdInfo': {'id': 'ST-4/Aliskiren/2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'C - A - B', 'description': '(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg', 'interventionNames': ['Drug: aliskiren, eplerenon, telmisartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B - A - C', 'description': '(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg', 'interventionNames': ['Drug: aliskiren, eplerenon, telmisartan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A - B - C', 'description': '(A) telmisartan 80 mg + aliskiren 300 mg - (B) telmisartan 80 mg + eplerenon 50 mg - (C) telmisartan 160 mg', 'interventionNames': ['Drug: aliskiren, eplerenon, telmisartan']}], 'interventions': [{'name': 'aliskiren, eplerenon, telmisartan', 'type': 'DRUG', 'description': 'aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)', 'armGroupLabels': ['A - B - C', 'B - A - C', 'C - A - B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bolesław Rutkowski, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Departmen of Nephrology, Transplantation adn Internal Medicine, Medical University of Gdańsk, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Gdansk', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Leszek Tylicki', 'investigatorAffiliation': 'Medical University of Gdansk'}}}}