Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-05 @ 6:09 PM
Study NCT ID:
NCT01100203
Status:
TERMINATED
Last Update Posted:
2012-02-08
First Post:
2010-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aldosterone Blockade in Chronic Kidney Disease: Influence on Arterial Stiffness and Kidney Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077545', 'term': 'Eplerenone'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'whyStopped': 'It was not possible within the time frame to recruit the planned no. of patients.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-07', 'studyFirstSubmitDate': '2010-04-06', 'studyFirstSubmitQcDate': '2010-04-07', 'lastUpdatePostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulse wave velocity', 'timeFrame': '24 weeks', 'description': 'Pulse wave velocity measured using the SphygmoCor device.'}, {'measure': 'Pulse Wave velocity', 'timeFrame': '12 weeks'}, {'measure': 'Pulse wave velocity', 'timeFrame': 'baseline'}], 'secondaryOutcomes': [{'measure': 'Ambulatory arterial stiffness index', 'timeFrame': '24 weeks', 'description': '24 hour ambulatory blood pressure measurements, give rise to the index, which is a secondary measure of arterial compliance.'}, {'measure': 'Pulse wave analysis', 'timeFrame': '24 weeks', 'description': 'Parameters are Augmentation Index, subendocardial viability ratio, pulse, time to reflection, ejection duration.'}, {'measure': 'Albuminuria', 'timeFrame': 'baseline', 'description': 'Will be calculated from 24 hour urine collections.'}, {'measure': 'Pulse wave analysis', 'timeFrame': 'baseline'}, {'measure': 'Ambulatory arterial stiffness index', 'timeFrame': 'baseline'}, {'measure': 'Ambulatory arterial stiffness index', 'timeFrame': '12 weeks'}, {'measure': 'Pulse wave analysis', 'timeFrame': '12 weeks'}, {'measure': 'Albuminuria', 'timeFrame': '12 weeks'}, {'measure': 'Albuminuria', 'timeFrame': '24 weeks'}, {'measure': 'Estimated glomerular filtration rate (eGFR)', 'timeFrame': 'baseline', 'description': 'Estimated glomerular filtration rate (eGFR) will be calculated by using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.'}, {'measure': 'Estimated glomerular filtration rate (eGFR)', 'timeFrame': '12 weeks'}, {'measure': 'Estimated glomerular filtration rate (eGFR)', 'timeFrame': '24 weeks'}, {'measure': 'Plasma potassium', 'timeFrame': 'baseline'}, {'measure': 'Plasma potassium', 'timeFrame': 'week 1'}, {'measure': 'Plasma potassium', 'timeFrame': 'week 2'}, {'measure': 'Plasma potassium', 'timeFrame': 'week 4'}, {'measure': 'Plasma potassium', 'timeFrame': 'week 8'}, {'measure': 'Plasma potassium', 'timeFrame': 'week 12'}, {'measure': 'Plasma potassium', 'timeFrame': 'week 16'}, {'measure': 'plasma potassium', 'timeFrame': 'week 20'}, {'measure': 'plasma potassium', 'timeFrame': 'week 24'}, {'measure': 'Blood pressure', 'timeFrame': 'baseline', 'description': 'BP will be measured at all visits'}, {'measure': 'Blood pressure', 'timeFrame': '12 weeks'}, {'measure': 'Blood pressure', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['aldosterone receptor inhibition', 'arterial stiffness', 'ambulatory arterial stiffness index'], 'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '33107592', 'type': 'DERIVED', 'citation': 'Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.'}, {'pmid': '23704994', 'type': 'DERIVED', 'citation': 'Boesby L, Elung-Jensen T, Strandgaard S, Kamper AL. Eplerenone attenuates pulse wave reflection in chronic kidney disease stage 3-4--a randomized controlled study. PLoS One. 2013 May 21;8(5):e64549. doi: 10.1371/journal.pone.0064549. Print 2013.'}]}, 'descriptionModule': {'briefSummary': 'Patients with Chronic Kidney Disease (CKD) have a poor prognosis primarily due to cardiovascular disease. The cardiovascular risk can be assessed by measurements of arterial stiffness. A decrease in stiffness has been shown to decrease the risk of cardiovascular disease as well as death. Most of the CKD population also have hypertension and the control of blood pressure is one of the corner stones in inhibition of disease progression. Using drugs that specifically block the renin-angiotensin-system for blood pressure control has been shown to have a beneficial impact on inhibition of progression beyond that of the achieved blood pressure control. It has been reported that inhibition of the hormone aldosterone has a positive effect on survival in patients with heart failure, hypertension and diabetic as well as on-diabetic nephropathy.\n\nThis study undertakes the investigation of the influence on arterial stiffness of adding an aldosterone receptor inhibitor to the medication CKD patients are already taking. Besides the primary end point which is Pulse wave velocity (PWV), arterial stiffness is also quantified thorough ambulatory blood pressure measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥ 18 years age ≤ 80 years age\n* voluntarily signed informed consent\n* 15 ml/min/1,73 m2 ≤ estimated Glomerular Filtration Rate \\< 60 ml/min/1,73 m2\n* BP ≥ 130/80 mmHg or undergoing anti-hypertensive treatment\n\nExclusion Criteria:\n\n* p-potassium is \\> 5.0 mM\n* allergy to contents\n* treated with spironolactone\n* treated with potent inhibitors of CYP3A4 (see SPC for details)\n* treated with lithium, ciclosporin, tacrolimus, prednisolone, or other immunosuppressing drug\n* inborn errors of metabolism (see SPC for details)\n* pregnancy or lactation\n* fertile woman, not using safe contraception devices\n* dementia or other psychiatric disorder, making understanding of the study conditions impossible\n* other severe, chronic illness besides CKD, including liver insufficiency, according to investigators' judgement\n* vascular surgery including stenting or graft implantation on a. brachialis, aorta or the carotid arteries\n* systolic BP \\> 200 mmHg\n* immeasurable pulse amplitude"}, 'identificationModule': {'nctId': 'NCT01100203', 'acronym': 'ALBLOCK-2', 'briefTitle': 'Aldosterone Blockade in Chronic Kidney Disease: Influence on Arterial Stiffness and Kidney Function', 'organization': {'class': 'OTHER', 'fullName': 'Herlev Hospital'}, 'officialTitle': 'Aldosterone Blockade in Chronic Kidney Disease. Influence on Arterial Stiffness and Kidney Function', 'orgStudyIdInfo': {'id': 'ALBLOCK-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment', 'interventionNames': ['Drug: Eplerenone']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Eplerenone', 'type': 'DRUG', 'description': '25 mg once daily 1 week, then 50 mg once daily for another 23 weeks.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Dept. Nephrology, Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'zip': 'DK-2730', 'city': 'Herlev', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}], 'overallOfficials': [{'name': 'Lene Boesby, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Herlev Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lene Boesby', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Lene Boesby', 'investigatorAffiliation': 'Herlev Hospital'}}}}