{ "FullStudy":{ "Rank":217619, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01519037", "OrgStudyIdInfo":{ "OrgStudyId":"2011DR4219" }, "Organization":{ "OrgFullName":"Centre Hospitalier Universitaire Vaudois", "OrgClass":"OTHER" }, "BriefTitle":"Interaction Between a Calcimimetic Agent and the Renin Angiotensine Aldosterone System", "OfficialTitle":"Evaluation of the Interaction Between a Calcimimetic Agent (Cinacalcet) and the Renin Angiotensine Aldosterone System in Healthy Volunteers" }, "StatusModule":{ "StatusVerifiedDate":"March 2020", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"June 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"June 2014", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 24, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 3, 2020", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 5, 2020", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Michel Burnier", "ResponsiblePartyInvestigatorTitle":"Professor", "ResponsiblePartyInvestigatorAffiliation":"Centre Hospitalier Universitaire Vaudois" }, "LeadSponsor":{ "LeadSponsorName":"Centre Hospitalier Universitaire Vaudois", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Swiss National Science Foundation", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The aim of this study is to evaluate, in healthy volunteers, the acute modulating effect of cinacalcet on the RAAS, the effect of furosemide on parathyroid secretion of PTH and the interaction between furosemide and cinacalcet on parathyroid hormone secretion.", "DetailedDescription":"The clinical trial will be monocentric (Service of Nephrology and Hypertension at CHUV, Lausanne) and will include 24 patients. The volunteers will get involved after inclusion (Inclusion Visit) in a crossover study over two double-blind periods. The order of the two periods (placebo or cinacalcet) will be randomized. Each period comprises 3 days of a low-sodium diet (50 mmol of Na+ per day, equivalent to 3 grams of salt/day), followed by an investigation day at the hospital during which the subjects will be studied before and after exposure to the cinacalcet or placebo. The 2 periods will be separated by a therapeutic wash-out lasting 14-28 days. The total length of the study per participant will be 1, max. 2 months." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Relationship Between Calcimimetic and the RAAS" ] }, "KeywordList":{ "Keyword":[ "calcimimetic agent", "RAAS", "renin", "aldosterone" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Basic Science", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"18", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"calcimimetic agent (cinacalcet)", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"3 days of a low-sodium diet (50 mmol of Na+ per day, equivalent to 3 grams of salt/day), followed by an investigation day at the hospital during which the subjects will be studied before and after exposure to the cinacalcet or the placebo. The 2 periods will be separated by a therapeutic wash-out lasting 14-28 days. The total length of the study per participant will be 1, max. 2 months", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Cinacalcet 60 MG" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"3 days of a low-sodium diet (50 mmol of Na+ per day, equivalent to 3 grams of salt/day), followed by an investigation day at the hospital during which the subjects will be studied before and after exposure to the cinacalcet or placebo. The 2 periods will be separated by a therapeutic wash-out lasting 14-28 days. The total length of the study per participant will be 1, max. 2 months", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo oral tablet" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Cinacalcet 60 MG", "InterventionDescription":"one dose of oral cinacalcet, 60mg", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "calcimimetic agent (cinacalcet)" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo oral tablet", "InterventionDescription":"one tablet of placebo", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Effect of cinacalcet compared to placebo on plasma renin activity", "PrimaryOutcomeDescription":"to determine the acute effect of a single high dose of cinacalcet compared to placebo on plasma renin activity (PRA), under RAAS-stimulating conditions (low sodium diet, furosemide injection) by PRA plasma measure", "PrimaryOutcomeTimeFrame":"up to 36 days" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"effect of cinacalcet administered as single dose (compared to placebo) on plasma aldosterone and on hemodynamics", "SecondaryOutcomeDescription":"to determine the effect of cinacalcet administered as single dose (compared to placebo) on plasma aldosterone and on hemodynamics (blood pressure, heart rate), under RAAS stimulating conditions (low sodium diet, furosemide injection).", "SecondaryOutcomeTimeFrame":"up to 36 days" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nHealthy subject\n\nMale\n\nAge > 18 and < 45 years old\nCaucasian\nNon-smoker\nBMI >18 and < 25 Kg/m2\nNormal clinical examination\nECG normal, 12 leads\nSystolic arterial pressure (SBP) ≥100 ≤ 139 mmHg and diastolic arterial pressure (DBP) ≥50 ≤ 89 mmHg (after 5 minutes lying down, 3 measurements at 2-minute intervals; Omron machine; left arm)\nHeart rate (HR) ≥ 45 ≤ 90 beats/min\nSubject capable of understanding the written information and the written consent form.\nSubject must have given written, dated and signed consent before starting any trial procedure.\n\nExclusion Criteria:\n\n• Female\n\nAge < 18 or > 45 years old\nElectrolyte disturbances, defined as any sodium, potassium, total or ionized calcium, phosphate or magnesium value outside of the laboratory's reference values (at the Inclusion Visit).\nSeropositive for HIV, HBV or HCV (at the Inclusion Visit).\nPositive detection of drugs in urine (opiates, cannabinoids, cocaine, benzodiazepines, amphetamines or barbiturates) (at the Inclusion Visit).\nFall in SBP > or DBP > 10 mmHg after standing for 1 minute or any clinical manifestation of postural hypotension (at the Inclusion Visit).\nAny history of diseases or clinically significant conditions which may be gastrointestinal (such as gastritis or gastric ulcer), respiratory, psychiatric, neurological (medical history of convulsions), renal, hepatic or cardiac or other diseases/conditions or abnormal physical signs which may interfere with the study's objectives. The investigator may disqualify any subject for a valid medical or psychiatric reason.\nOngoing involvement or in the 60 days prior to the Inclusion Visit in another research study.\nChronic use of any medication (prescribed or not) during the 4 weeks prior to the Inclusion Visit (only the use of medications such as paracetamol for headaches will be tolerated at the lowest dose possible.\nUse of any medication known as CYP P450 3A4 inhibitors during the 12 weeks prior to the Inclusion Visit (amiodarone, diltiazem, verapamil, ketoconazole, itraconazole, voriconazole, posaconazole, fluconazole, miconazol, ritonavir, nelfinavir, amprenavir, indinavir, atazanavir, erythromycin, clarithromycin, josamycin, telithromycin)\nDonation of blood, plasma and/or marrow in the 3 months prior to the Inclusion Visit\nMedical history of dependence on drugs or alcohol abuse as defined by the DSM IVR, criteria for diagnosing drug and alcohol abuse and dependence on drugs.\nMedical history of intolerant reactions to cinacalcet or furosemide (or derivatives of sulfamides)", "HealthyVolunteers":"Accepts Healthy Volunteers", "Gender":"Male", "MinimumAge":"18 Years", "MaximumAge":"45 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Michel Burnier, Professor", "OverallOfficialAffiliation":"CHUV", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"CHUV, service de néphrologie/hypertension", "LocationCity":"Lausanne", "LocationState":"Vaud", "LocationZip":"1011", "LocationCountry":"Switzerland" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"19593209", "ReferenceType":"background", "ReferenceCitation":"Maillard MP, Tedjani A, Perregaux C, Burnier M. Calcium-sensing receptors modulate renin release in vivo and in vitro in the rat. J Hypertens. 2009 Oct;27(10):1980-7. doi: 10.1097/HJH.0b013e32832f0d22." },{ "ReferencePMID":"26089029", "ReferenceType":"result", "ReferenceCitation":"Muller ME, Forni Ogna V, Maillard M, Stoudmann C, Zweiacker C, Anex C, Wuerzner G, Burnier M, Bonny O. Furosemide stimulation of parathormone in humans: role of the calcium-sensing receptor and the renin-angiotensin system. Pflugers Arch. 2015 Dec;467(12):2413-21. doi: 10.1007/s00424-015-1714-4. Epub 2015 Jun 20." } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No", "IPDSharingDescription":"Publication" } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000069449", "InterventionMeshTerm":"Cinacalcet" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000077264", "InterventionAncestorTerm":"Calcium-Regulating Hormones and Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000057966", "InterventionAncestorTerm":"Calcimimetic Agents" },{ "InterventionAncestorId":"D000006727", "InterventionAncestorTerm":"Hormone Antagonists" },{ "InterventionAncestorId":"D000006730", "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M418", "InterventionBrowseLeafName":"Cinacalcet", "InterventionBrowseLeafAsFound":"Cinacalcet", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M3963", "InterventionBrowseLeafName":"Calcium", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M3980", "InterventionBrowseLeafName":"Calcium, Dietary", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8372", "InterventionBrowseLeafName":"Hormones", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8371", "InterventionBrowseLeafName":"Hormone Antagonists", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"BDCA", "InterventionBrowseBranchName":"Bone Density Conservation Agents" } ] } } } } } }