Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT01832558
Status:
UNKNOWN
Last Update Posted:
2020-06-19
First Post:
2013-04-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The EPOCH Study (Eplerenone on Top of ACE Inhibition in Chronic Kidney Disease Patients With Hypertension)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-06-17', 'studyFirstSubmitDate': '2013-04-08', 'studyFirstSubmitQcDate': '2013-04-15', 'lastUpdatePostDateStruct': {'date': '2020-06-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Angiotensin levels (pg/ml) of CKD II-III patients with DM II with eplerenone additional to enalapril in comparison to patients who receive a placebo on top of enalapril therapy.', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['CKD II-III']}, 'referencesModule': {'references': [{'pmid': '22336987', 'type': 'BACKGROUND', 'citation': 'Shavit L, Lifschitz MD, Epstein M. Aldosterone blockade and the mineralocorticoid receptor in the management of chronic kidney disease: current concepts and emerging treatment paradigms. Kidney Int. 2012 May;81(10):955-968. doi: 10.1038/ki.2011.505. Epub 2012 Feb 15.'}, {'pmid': '17699311', 'type': 'BACKGROUND', 'citation': 'Epstein M, Williams GH, Weinberger M, Lewin A, Krause S, Mukherjee R, Patni R, Beckerman B. Selective aldosterone blockade with eplerenone reduces albuminuria in patients with type 2 diabetes. Clin J Am Soc Nephrol. 2006 Sep;1(5):940-51. doi: 10.2215/CJN.00240106. Epub 2006 Jul 19.'}]}, 'descriptionModule': {'briefSummary': 'In a prospective single centre placebo-controlled trial over ten weeks, 24 CKD II-III patients (eGFR 30-89 ml/min per 1.73 m2) with DM II will be randomized to enalapril 20mg per day after a two week run-in phase. Thereafter, patients will either receive eplerenone 25mg (n=12) or a placebo (n=12) for eight weeks. Eplerenone will be increased to 50mg under close monitoring of serum potassium levels. Employing a novel mass-spectrometry ( MS)-based method, quantification of up to 10 different Ang metabolites (Ang I, Ang II, Ang 1-7, Ang 1-9, Ang 2-10, Ang 1-5, Ang 2-7, Ang 3-7, Ang 3-8 and Ang 2-8) will be performed simultaneously out of blood sera (after run-in phase and after 10 weeks).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CKD II to III and diabetes mellitus type 2\n* CKD will be defined according to estimated glomerular filtration rate (eGFR) with the MDRD formula\n* eGFR between 30 and 89 ml/min\n* albumin excretion rates \\> 300 mg/24 hours (UACR \\> 300 mg/gram) or \\> 200 mg/g if already receiving any RAS blockade Patients should be hypertonic stage I or II according to the European guidelines (Chobanian et al. JAMA 2003)\n\nExclusion Criteria:\n\n* Age \\< 18 years\n* UACR \\> 3500mg/g\n* severe hypertension\n* pregnancy\n* unwilling or inability to sign the informed consent\n* coronary heart disease\n* systolic blood pressure \\< 130 mmHg\n* additional RAS interfering drugs (ACEis, ARBs, direct renin inhibitors)\n* 25-hydroxy vitamin D levels below 16.6±8.3 pg/ml\n* 1,25-dihydroxy vitamin D 33.1±15.5 pg/ml\n\nIntolerance to eplerenon or an excipient of it:\n\ntablettcore: Lactose-Monohydrat Mikrokristalline Cellulose (E 460) Croscarmellose-sodium (E 468) Hypromellose (E 464) Sodiumdodecylsulfat Talkum (E 553b) Magnesiumstearat (E 470b)\n\nfilmcoat\n\nOpadry, yellow:\n\nHypromellose (E 464) Titandioxid (E 171) Macrogol 400 Polysorbat 80 (E 433) Yellow ironoxide (E 172) Red ironoxide (E 172)\n\n* Patients with Serumpotassium \\> 5,0 mmol/l at start of the treatment\n* Patients with severe renal insufficiency (eGFR \\<30ml/min./1.73 m2)\n* Patients with severe liver insufficiency (Child-Pugh class C)\n* Patients taking potassium saving diuretics, potassium supplements or strong CYP3A4-inhibitors (z. B. Itraconazol, Ketoconazol, Ritonavir, Nelfinavir, Clarithromycin, Telithromycin und Nefazodon)'}, 'identificationModule': {'nctId': 'NCT01832558', 'briefTitle': 'The EPOCH Study (Eplerenone on Top of ACE Inhibition in Chronic Kidney Disease Patients With Hypertension)', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'orgStudyIdInfo': {'id': 'EudraCT: 2012-002175-34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Eplerenone', 'description': 'Eplerenone 25-50mg daily additionally to standard ACE-inhibition with enalapril 20mg daily', 'interventionNames': ['Drug: Eplerenone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo additionally to standard ACE-inhibition with enalapril 20mg daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Eplerenone', 'type': 'DRUG', 'armGroupLabels': ['Eplerenone']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Marcus Saemann, MD', 'role': 'CONTACT', 'email': 'marcus.saemann@meduniwien.ac.at', 'phone': '01/40400/55930'}, {'name': 'Johannes Kovarik, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Marcus Saemann, MD', 'role': 'CONTACT', 'email': 'marcus.saemann@meduniwien.ac.at', 'phone': '0043/4040055930'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof. Priv.-Doz. Dr.med.univ.', 'investigatorFullName': 'Marcus Saemann', 'investigatorAffiliation': 'Medical University of Vienna'}}}}