{
  "FullStudy":{
    "Rank":217669,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518387",
          "OrgStudyIdInfo":{
            "OrgStudyId":"11878"
          },
          "Organization":{
            "OrgFullName":"Bayer",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Open Study of BAY77-1931 (Lanthanum Carbonate) in Continuous Ambulatory Peritoneal Dialysis Patients",
          "OfficialTitle":"Phase III Open Study of BAY 77 1931 (Lanthanum Carbonate) in Patients With Hyperphosphatemia Undergoing Continuous Ambulatory Peritoneal Dialysis (CAPD)"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2006"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2006",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2006",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 10, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 14, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Bayer",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (lanthanum carbonate) in patients with hyperphosphatemia undergoing continuous ambulatory peritoneal dialysis."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Hyperphosphatemia"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"43",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Arm 1",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"750-2250mg/day, tid, 8 weeks",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Lanthanum Carbonate (BAY77-1931)"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Lanthanum Carbonate (BAY77-1931)",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Arm 1"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change from baseline in serum phosphate levels at the end of the treatment period",
                "PrimaryOutcomeTimeFrame":"Baseline to Week 8"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Number of participants achieving the target PSPL (Pre-dialysis serum phosphate level) and time to achievement",
                "SecondaryOutcomeTimeFrame":"Week 8"
              },{
                "SecondaryOutcomeMeasure":"Serum calcium level corrected by serum albumin level at the end of the treatment period",
                "SecondaryOutcomeTimeFrame":"Week 8"
              },{
                "SecondaryOutcomeMeasure":"Serum calcium x phosphate product at the end of the treatment period",
                "SecondaryOutcomeTimeFrame":"Week 8"
              },{
                "SecondaryOutcomeMeasure":"Serum intact-PTH (Parathyroid) levels at the end of the treatment period",
                "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\nSerum phosphate levels: >5.0 mg/dL and <11.0 mg/dL 2 weeks after the initiation of the washout period\nOut-patient\nUndergoing CAPD for at least previous 3 consecutive months\n\nExclusion Criteria:\n\nWho may not enable to continue CAPD\nSerum phosphate levels of >=10.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 week after\nCorrected serum calcium level of <7.0 mg/dL at the start of the washout period or >=11.0 mg/dL 2 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",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"20 Years",
          "MaximumAge":"75 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Bayer Study Director",
                "OverallOfficialAffiliation":"Bayer",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationCity":"Asahikawa",
                "LocationState":"Hokkaido",
                "LocationZip":"070-0030",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Kamakura",
                "LocationState":"Kanagawa",
                "LocationZip":"247-0072",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Yokosuka",
                "LocationState":"Kanagawa",
                "LocationZip":"238-0011",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Osaki",
                "LocationState":"Miyagi",
                "LocationZip":"989-6117",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Sendai",
                "LocationState":"Miyagi",
                "LocationZip":"981-0912",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Meguro-ku",
                "LocationState":"Tokyo",
                "LocationZip":"153-0061",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Fukuoka",
                "LocationZip":"815-0082",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Gifu",
                "LocationZip":"500-8717",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Hiroshima",
                "LocationZip":"730-8655",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Okayama",
                "LocationZip":"700-0013",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Tokushima",
                "LocationZip":"770-0011",
                "LocationCountry":"Japan"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "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"
              }
            ]
          }
        }
      }
    }
  }
}