{
  "FullStudy":{
    "Rank":218090,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512862",
          "OrgStudyIdInfo":{
            "OrgStudyId":"SNUH-CCTO"
          },
          "Organization":{
            "OrgFullName":"Seoul National University Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Anti-proteinuric Effect of Calcitriol in Non-diabetic Kidney Disease Patients",
          "OfficialTitle":"Additive Renoprotective Effects of Oral Calcitriol in Nondiabetic Chronic Kidney Disease Patients"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2012",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2013",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 13, 2012",
          "StudyFirstSubmitQCDate":"January 18, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 9, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 10, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Yon Su Kim",
            "ResponsiblePartyInvestigatorTitle":"Professor",
            "ResponsiblePartyInvestigatorAffiliation":"Seoul National University Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Seoul National University Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Proteinuria is not only a marker of chronic kidney disease (CKD) progression, but also a marker of cardiovascular disease and death. In previous studies, active vitamin D deficiency is associated with cardiovascular risk factors such as albuminuria, diabetes mellitus, and lower glomerular filtration rate (GFR). And calcitriol was shown to have a preventive effect in progressive glomerular damage in a renal ablation model. Calcitriol, an active form of vitamin D (1,25-dihydroxyvitamin-D3), is commonly used for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney diseases.\n\nTherefore, the objective of this study is to evaluate the anti-proteinuric effect of calcitriol in non-diabetic kidney disease patients. They will be treated with calcitriol and placebo for 24 weeks and observed for 24 weeks after treatment. Proteinuria, renal function, serum and urinary inflammatory markers, and adverse event will be monitored."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Proteinuria"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Calcitriol",
              "Off-label"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"240",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Calcitriol",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Calcitriol"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo",
                "ArmGroupType":"No Intervention",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Calcitriol",
                "InterventionDescription":"Dosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Calcitriol"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Calcio® (Hanmi Pharm Co., Korea)"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Placebo",
                "InterventionDescription":"Dosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Changes in proteinuria",
                "PrimaryOutcomeDescription":"Comparison of proteinuria amount checked by random urine protein/creatinine ratio",
                "PrimaryOutcomeTimeFrame":"6, 12 months after administration"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Changes in renal function",
                "SecondaryOutcomeDescription":"Comparison of in serum creatinine level from baseline",
                "SecondaryOutcomeTimeFrame":"3, 6, 9 and 12 months"
              },{
                "SecondaryOutcomeMeasure":"Changes in urinary renal damage markers",
                "SecondaryOutcomeDescription":"Comparison of urinary TGF-beta, TNF-alpha, MCP-1 level from baseline",
                "SecondaryOutcomeTimeFrame":"6, 12 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nNondiabetic kidney disease patients aged 19-70 years\nMDRD GFR ≥ 30 mL/min/1.73m2\nPatients with residual urine protein/creatinine ratio > 200 mg/g\nAdequate blood pressure control as treated systolic blood pressure <=140 or diastolic <=90 mmHg with RAS inhibitor for more than 3 months\nNormotensive patients untreated with RAS inhibitors\nSerum intact PTH as 35-500 mg/dL and serum calcium less than 10.2 mg/dL\nPatients who have not been treated vitamin D within the 3 months prior to signing the informed consent form\n\nExclusion Criteria:\n\nPatients with nephrotic-range proteinuria (24 hour urine protein >3.5 g/24 hr)\nPatients with rapidly progressive glomerulonephritis\nPatients requiring renal replacement therapy immediately\nHypercalcemia (uncorrected serum calcium level > 10.2 mg/dL) within 3 months\nMalignant hypertension\nHeart failure (New York Heart Association [NYHA] functional class II to IV or LVEF less than 40%)\nSevere chronic obstructive lung disease\nDecompensated liver disease\nKnown allergy or hypersensitivity to vitamin D\nCurrent treatment with steroids and/or immunosuppressive agents\nNo other active primary malignancy requiring treatment or that limits survival to ≤ 2 years\nHistory of noncompliance to medical regimen\nInability to give an informed consent or to cooperate with researchers (e.g., psychiatric disorder)",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"19 Years",
          "MaximumAge":"70 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "CentralContactList":{
            "CentralContact":[
              {
                "CentralContactName":"Nayoung Han, M.S.",
                "CentralContactRole":"Contact",
                "CentralContactPhone":"+82-2-2072-0335",
                "CentralContactEMail":"hans1217@snu.ac.kr"
              }
            ]
          },
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Jung Mi Oh, Pharm.D.",
                "OverallOfficialAffiliation":"Seoul National Univerisy College of Pharmacy",
                "OverallOfficialRole":"Study Chair"
              },{
                "OverallOfficialName":"Yon Su Kim, M.D., Ph.D.",
                "OverallOfficialAffiliation":"Seoul National University Hospital",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Seoul National University Bundang Hospital",
                "LocationStatus":"Enrolling by invitation",
                "LocationCity":"Seongnam",
                "LocationState":"Gyeonggi-do",
                "LocationZip":"463-707",
                "LocationCountry":"Korea, Republic of"
              },{
                "LocationFacility":"Seoul National University Hospital",
                "LocationStatus":"Recruiting",
                "LocationCity":"Seoul",
                "LocationZip":"110-744",
                "LocationCountry":"Korea, Republic of",
                "LocationContactList":{
                  "LocationContact":[
                    {
                      "LocationContactName":"Yon Su Kim, M.D., Ph.D.",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"82-2-2072-2264",
                      "LocationContactEMail":"yonsukim@snu.ac.kr"
                    },{
                      "LocationContactName":"Dong Ki Kim, M.D., Ph.D.",
                      "LocationContactRole":"Contact",
                      "LocationContactPhone":"82-2-2072-2303",
                      "LocationContactEMail":"dkkim73@gmail.com"
                    },{
                      "LocationContactName":"Yon Su Kim, M.D., Ph.D.",
                      "LocationContactRole":"Principal Investigator"
                    },{
                      "LocationContactName":"Dong Ki Kim, M.D., Ph.D.",
                      "LocationContactRole":"Sub-Investigator"
                    },{
                      "LocationContactName":"Nayoung Han, M.S.",
                      "LocationContactRole":"Sub-Investigator"
                    }
                  ]
                }
              },{
                "LocationFacility":"SMG-SNU Boramae Medical Center",
                "LocationStatus":"Enrolling by invitation",
                "LocationCity":"Seoul",
                "LocationZip":"156-707",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000002117",
                "InterventionMeshTerm":"Calcitriol"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000077264",
                "InterventionAncestorTerm":"Calcium-Regulating Hormones and Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000002120",
                "InterventionAncestorTerm":"Calcium Channel Agonists"
              },{
                "InterventionAncestorId":"D000049990",
                "InterventionAncestorTerm":"Membrane Transport Modulators"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000014662",
                "InterventionAncestorTerm":"Vasoconstrictor Agents"
              },{
                "InterventionAncestorId":"D000014815",
                "InterventionAncestorTerm":"Vitamins"
              },{
                "InterventionAncestorId":"D000018977",
                "InterventionAncestorTerm":"Micronutrients"
              },{
                "InterventionAncestorId":"D000078622",
                "InterventionAncestorTerm":"Nutrients"
              },{
                "InterventionAncestorId":"D000006133",
                "InterventionAncestorTerm":"Growth Substances"
              },{
                "InterventionAncestorId":"D000050071",
                "InterventionAncestorTerm":"Bone Density Conservation Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M3963",
                "InterventionBrowseLeafName":"Calcium",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M3962",
                "InterventionBrowseLeafName":"Calcitriol",
                "InterventionBrowseLeafAsFound":"Calcitriol",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M3980",
                "InterventionBrowseLeafName":"Calcium, Dietary",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8372",
                "InterventionBrowseLeafName":"Hormones",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M15992",
                "InterventionBrowseLeafName":"Vasoconstrictor Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M16141",
                "InterventionBrowseLeafName":"Vitamins",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M15468",
                "InterventionBrowseLeafName":"Trace Elements",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19593",
                "InterventionBrowseLeafName":"Micronutrients",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M1986",
                "InterventionBrowseLeafName":"Nutrients",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"BDCA",
                "InterventionBrowseBranchName":"Bone Density Conservation Agents"
              },{
                "InterventionBrowseBranchAbbrev":"Micro",
                "InterventionBrowseBranchName":"Micronutrients"
              },{
                "InterventionBrowseBranchAbbrev":"VaCoAg",
                "InterventionBrowseBranchName":"Vasoconstrictor Agents"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000007674",
                "ConditionMeshTerm":"Kidney Diseases"
              },{
                "ConditionMeshId":"D000011507",
                "ConditionMeshTerm":"Proteinuria"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000014570",
                "ConditionAncestorTerm":"Urologic Diseases"
              },{
                "ConditionAncestorId":"D000014555",
                "ConditionAncestorTerm":"Urination Disorders"
              },{
                "ConditionAncestorId":"D000020924",
                "ConditionAncestorTerm":"Urological Manifestations"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9281",
                "ConditionBrowseLeafName":"Kidney Diseases",
                "ConditionBrowseLeafAsFound":"Kidney Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M12951",
                "ConditionBrowseLeafName":"Proteinuria",
                "ConditionBrowseLeafAsFound":"Proteinuria",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M15902",
                "ConditionBrowseLeafName":"Urologic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15888",
                "ConditionBrowseLeafName":"Urination Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21243",
                "ConditionBrowseLeafName":"Urological Manifestations",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BXS",
                "ConditionBrowseBranchName":"Urinary Tract, Sexual Organs, and Pregnancy Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}