{
  "FullStudy":{
    "Rank":217940,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514851",
          "OrgStudyIdInfo":{
            "OrgStudyId":"11877"
          },
          "Organization":{
            "OrgFullName":"Bayer",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate",
          "OfficialTitle":"Phase III Double-blind Comparative Study of BAY 77 1931 (Lanthanum Carbonate) With a Calcium Carbonate in Patients With Hyperphosphatemia Undergoing Hemodialysis"
        },
        "StatusModule":{
          "StatusVerifiedDate":"June 2012",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2006"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2006",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2006",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"June 7, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"June 8, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyOldNameTitle":"Head Medical Development Japan",
            "ResponsiblePartyOldOrganization":"Bayer Yakuhin Ltd."
          },
          "LeadSponsor":{
            "LeadSponsorName":"Bayer",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Hyperphosphatemia"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"259",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Arm 1",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"750-2250mg/day, tid (three times a day), 8 weeks",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Lanthanum carbonate (BAY77-1931)"
                  ]
                }
              },{
                "ArmGroupLabel":"Arm 2",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"1500-4500mg/day, tid, 8 weeks",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Calcium carbonate"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Lanthanum carbonate (BAY77-1931)",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Arm 1"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Calcium carbonate",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Arm 2"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period",
                "PrimaryOutcomeTimeFrame":"baseline to week 8"
              },{
                "PrimaryOutcomeMeasure":"Presence/absence of incidence of hypercalcemia up to 8 weeks",
                "PrimaryOutcomeTimeFrame":"up to 8 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Number of participants achieving target PSPL and time to achievement",
                "SecondaryOutcomeTimeFrame":"up to 8 weeks"
              },{
                "SecondaryOutcomeMeasure":"Serum calcium x phosphate product at the end of the double-blind treatment period",
                "SecondaryOutcomeTimeFrame":"Week 8"
              },{
                "SecondaryOutcomeMeasure":"Serum intact-PTH (Parathyroid) levels",
                "SecondaryOutcomeTimeFrame":"Week 8"
              },{
                "SecondaryOutcomeMeasure":"Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period",
                "SecondaryOutcomeTimeFrame":"Week 8"
              },{
                "SecondaryOutcomeMeasure":"Number of participants achieving the target serum calcium levels",
                "SecondaryOutcomeTimeFrame":"Week 8"
              },{
                "SecondaryOutcomeMeasure":"Safety variables will be summarized using descriptive statistics based on adverse events collection",
                "SecondaryOutcomeTimeFrame":"8 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPre-dialysis serum phosphate levels: ≧5.6 mg/dL and <11.0 mg/dL at 1 week after the initiation of the washout period.\nOut-patient\nUndergoing hemodialysis three times per week for at least previous 3 consecutive months\n\nExclusion Criteria:\n\nPre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after\nCorrected serum calcium level of <7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 week after\nSerum intact PTH (Parathyroid) of ≧1000 pg/mL at the start of the washout period\nPregnant woman, or lactating mother\nSignificant gastrointestinal disorders including known acute peptic ulcer\nLiver dysfunction\nHistory of cardiovascular or cerebrovascular diseases\nRequiring treatment for hypothyroidism",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"20 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Bayer Study Director",
                "OverallOfficialAffiliation":"Bayer",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationCity":"Toyohashi",
                "LocationState":"Aichi",
                "LocationZip":"441-8023",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Yatomi",
                "LocationState":"Aichi",
                "LocationZip":"498-0006",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Asahi",
                "LocationState":"Chiba",
                "LocationZip":"289-2511",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Kashiwa",
                "LocationState":"Chiba",
                "LocationZip":"277-0084",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Matsudo",
                "LocationState":"Chiba",
                "LocationZip":"271-0077",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Narita",
                "LocationState":"Chiba",
                "LocationZip":"286-0041",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Kurume",
                "LocationState":"Fukuoka",
                "LocationZip":"830-8522",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Kurume",
                "LocationState":"Fukuoka",
                "LocationZip":"830-8543",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Isesaki",
                "LocationState":"Gunma",
                "LocationZip":"379-2211",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Kobe",
                "LocationState":"Hyogo",
                "LocationZip":"658-0084",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Mito",
                "LocationState":"Ibaraki",
                "LocationZip":"310-0844",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Tsuchiura",
                "LocationState":"Ibaraki",
                "LocationZip":"300-0053",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Takamatsu",
                "LocationState":"Kagawa",
                "LocationZip":"761-8024",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Osaki",
                "LocationState":"Miyagi",
                "LocationZip":"989-6117",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Sendai",
                "LocationState":"Miyagi",
                "LocationZip":"981-0912",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Suita",
                "LocationState":"Osaka",
                "LocationZip":"564-0053",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Fuji",
                "LocationState":"Shizuoka",
                "LocationZip":"417-0056",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Hamamatsu",
                "LocationState":"Shizuoka",
                "LocationZip":"430-0903",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Arakawa-ku",
                "LocationState":"Tokyo",
                "LocationZip":"116-0003",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Kodaira",
                "LocationState":"Tokyo",
                "LocationZip":"187-0001",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Nerima-ku",
                "LocationState":"Tokyo",
                "LocationZip":"176-0023",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Shibuya-ku",
                "LocationState":"Tokyo",
                "LocationZip":"151-0053",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Shinjyuku-ku",
                "LocationState":"Tokyo",
                "LocationZip":"160-0023",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Chiba",
                "LocationZip":"261-0011",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Hiroshima",
                "LocationZip":"730-0811",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Kochi",
                "LocationZip":"780-0066",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Okayama",
                "LocationZip":"701-0202",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Saitama",
                "LocationZip":"330-0854",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Saitama",
                "LocationZip":"330-0856",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Saitama",
                "LocationZip":"337-0043",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Tokushima",
                "LocationZip":"770-0011",
                "LocationCountry":"Japan"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000002119",
                "InterventionMeshTerm":"Calcium Carbonate"
              },{
                "InterventionMeshId":"D000002118",
                "InterventionMeshTerm":"Calcium"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000077264",
                "InterventionAncestorTerm":"Calcium-Regulating Hormones and Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000000863",
                "InterventionAncestorTerm":"Antacids"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000005765",
                "InterventionAncestorTerm":"Gastrointestinal Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M3963",
                "InterventionBrowseLeafName":"Calcium",
                "InterventionBrowseLeafAsFound":"Calcium",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M3980",
                "InterventionBrowseLeafName":"Calcium, Dietary",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M3964",
                "InterventionBrowseLeafName":"Calcium Carbonate",
                "InterventionBrowseLeafAsFound":"Calcium carbonate",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M8372",
                "InterventionBrowseLeafName":"Hormones",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2769",
                "InterventionBrowseLeafName":"Antacids",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2800",
                "InterventionBrowseLeafName":"Anti-Ulcer Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M7464",
                "InterventionBrowseLeafName":"Gastrointestinal Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"BDCA",
                "InterventionBrowseBranchName":"Bone Density Conservation Agents"
              },{
                "InterventionBrowseBranchAbbrev":"Gast",
                "InterventionBrowseBranchName":"Gastrointestinal Agents"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000054559",
                "ConditionMeshTerm":"Hyperphosphatemia"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010760",
                "ConditionAncestorTerm":"Phosphorus Metabolism Disorders"
              },{
                "ConditionAncestorId":"D000008659",
                "ConditionAncestorTerm":"Metabolic Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9282",
                "ConditionBrowseLeafName":"Kidney Failure, Chronic",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9281",
                "ConditionBrowseLeafName":"Kidney Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M26370",
                "ConditionBrowseLeafName":"Hyperphosphatemia",
                "ConditionBrowseLeafAsFound":"Hyperphosphatemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M10222",
                "ConditionBrowseLeafName":"Metabolic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M12243",
                "ConditionBrowseLeafName":"Phosphorus Metabolism Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              }
            ]
          }
        }
      }
    }
  }
}