Nctid:
NCT00000935
Payload:
{"FullStudy"=>{"Rank"=>474679, "Study"=>{"DerivedSection"=>{"MiscInfoModule"=>{"VersionHolder"=>"December 08, 2023"}, "ConditionBrowseModule"=>{"ConditionMeshList"=>{"ConditionMesh"=>[{"ConditionMeshId"=>"D000007674", "ConditionMeshTerm"=>"Kidney Diseases"}, {"ConditionMeshId"=>"D000007676", "ConditionMeshTerm"=>"Kidney Failure, Chronic"}]}, "ConditionAncestorList"=>{"ConditionAncestor"=>[{"ConditionAncestorId"=>"D000014570", "ConditionAncestorTerm"=>"Urologic Diseases"}, {"ConditionAncestorId"=>"D000052776", "ConditionAncestorTerm"=>"Female Urogenital Diseases"}, {"ConditionAncestorId"=>"D000005261", "ConditionAncestorTerm"=>"Female Urogenital Diseases and Pregnancy Complications"}, {"ConditionAncestorId"=>"D000091642", "ConditionAncestorTerm"=>"Urogenital Diseases"}, {"ConditionAncestorId"=>"D000052801", "ConditionAncestorTerm"=>"Male Urogenital Diseases"}, {"ConditionAncestorId"=>"D000051436", "ConditionAncestorTerm"=>"Renal Insufficiency, Chronic"}, {"ConditionAncestorId"=>"D000051437", "ConditionAncestorTerm"=>"Renal Insufficiency"}, {"ConditionAncestorId"=>"D000002908", "ConditionAncestorTerm"=>"Chronic Disease"}, {"ConditionAncestorId"=>"D000020969", "ConditionAncestorTerm"=>"Disease Attributes"}, {"ConditionAncestorId"=>"D000010335", "ConditionAncestorTerm"=>"Pathologic Processes"}]}, "ConditionBrowseLeafList"=>{"ConditionBrowseLeaf"=>[{"ConditionBrowseLeafId"=>"M10388", "ConditionBrowseLeafName"=>"Kidney Diseases", "ConditionBrowseLeafAsFound"=>"Renal Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M10389", "ConditionBrowseLeafName"=>"Kidney Failure, Chronic", "ConditionBrowseLeafAsFound"=>"End Stage Renal Disease", "ConditionBrowseLeafRelevance"=>"high"}, {"ConditionBrowseLeafId"=>"M26408", "ConditionBrowseLeafName"=>"Renal Insufficiency", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M17009", "ConditionBrowseLeafName"=>"Urologic Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M2876", "ConditionBrowseLeafName"=>"Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M26783", "ConditionBrowseLeafName"=>"Female Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M13817", "ConditionBrowseLeafName"=>"Pregnancy Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M8089", "ConditionBrowseLeafName"=>"Female Urogenital Diseases and Pregnancy Complications", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M26785", "ConditionBrowseLeafName"=>"Male Urogenital Diseases", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M26407", "ConditionBrowseLeafName"=>"Renal Insufficiency, Chronic", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M5837", "ConditionBrowseLeafName"=>"Chronic Disease", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"M22390", "ConditionBrowseLeafName"=>"Disease Attributes", "ConditionBrowseLeafRelevance"=>"low"}, {"ConditionBrowseLeafId"=>"T1303", "ConditionBrowseLeafName"=>"Chronic Graft Versus Host Disease", "ConditionBrowseLeafRelevance"=>"low"}]}, "ConditionBrowseBranchList"=>{"ConditionBrowseBranch"=>[{"ConditionBrowseBranchName"=>"Urinary Tract, Sexual Organs, and Pregnancy Conditions", "ConditionBrowseBranchAbbrev"=>"BXS"}, {"ConditionBrowseBranchName"=>"All Conditions", "ConditionBrowseBranchAbbrev"=>"All"}, {"ConditionBrowseBranchName"=>"Symptoms and General Pathology", "ConditionBrowseBranchAbbrev"=>"BC23"}, {"ConditionBrowseBranchName"=>"Rare Diseases", "ConditionBrowseBranchAbbrev"=>"Rare"}]}}, "InterventionBrowseModule"=>{"InterventionMeshList"=>{"InterventionMesh"=>[{"InterventionMeshId"=>"D000007136", "InterventionMeshTerm"=>"Immunoglobulins"}, {"InterventionMeshId"=>"D000000906", "InterventionMeshTerm"=>"Antibodies"}, {"InterventionMeshId"=>"D000005719", "InterventionMeshTerm"=>"gamma-Globulins"}, {"InterventionMeshId"=>"D000016756", "InterventionMeshTerm"=>"Immunoglobulins, Intravenous"}, {"InterventionMeshId"=>"D000018029", "InterventionMeshTerm"=>"Rho(D) Immune Globulin"}]}, "InterventionAncestorList"=>{"InterventionAncestor"=>[{"InterventionAncestorId"=>"D000007155", "InterventionAncestorTerm"=>"Immunologic Factors"}, {"InterventionAncestorId"=>"D000045505", "InterventionAncestorTerm"=>"Physiological Effects of Drugs"}]}, "InterventionBrowseLeafList"=>{"InterventionBrowseLeaf"=>[{"InterventionBrowseLeafId"=>"M3915", "InterventionBrowseLeafName"=>"Antibodies", "InterventionBrowseLeafAsFound"=>"Cervical Cancer", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M9874", "InterventionBrowseLeafName"=>"Immunoglobulins", "InterventionBrowseLeafAsFound"=>"Cervical Cancer", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M18807", "InterventionBrowseLeafName"=>"Immunoglobulins, Intravenous", "InterventionBrowseLeafAsFound"=>"Alin Oftalmico", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M8526", "InterventionBrowseLeafName"=>"gamma-Globulins", "InterventionBrowseLeafAsFound"=>"Alin Oftalmico", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M19881", "InterventionBrowseLeafName"=>"Rho(D) Immune Globulin", "InterventionBrowseLeafAsFound"=>"Alin Oftalmico", "InterventionBrowseLeafRelevance"=>"high"}, {"InterventionBrowseLeafId"=>"M9891", "InterventionBrowseLeafName"=>"Immunologic Factors", "InterventionBrowseLeafRelevance"=>"low"}]}, "InterventionBrowseBranchList"=>{"InterventionBrowseBranch"=>[{"InterventionBrowseBranchName"=>"All Drugs and Chemicals", "InterventionBrowseBranchAbbrev"=>"All"}]}}}, "ProtocolSection"=>{"DesignModule"=>{"PhaseList"=>{"Phase"=>["Phase 3"]}, "StudyType"=>"Interventional", "DesignInfo"=>{"DesignAllocation"=>"Randomized", "DesignMaskingInfo"=>{"DesignMasking"=>"None (Open Label)"}, "DesignPrimaryPurpose"=>"Treatment", "DesignInterventionModel"=>"Parallel Assignment"}, "EnrollmentInfo"=>{"EnrollmentType"=>"Anticipated", "EnrollmentCount"=>"100"}}, "StatusModule"=>{"OverallStatus"=>"Completed", "ExpandedAccessInfo"=>{"HasExpandedAccess"=>"No"}, "StatusVerifiedDate"=>"January 2017", "CompletionDateStruct"=>{"CompletionDate"=>"June 2003", "CompletionDateType"=>"Actual"}, "LastUpdateSubmitDate"=>"January 10, 2017", "StudyFirstSubmitDate"=>"November 2, 1999", "StudyFirstSubmitQCDate"=>"August 30, 2001", "LastUpdatePostDateStruct"=>{"LastUpdatePostDate"=>"January 11, 2017", "LastUpdatePostDateType"=>"Estimate"}, "StudyFirstPostDateStruct"=>{"StudyFirstPostDate"=>"August 31, 2001", "StudyFirstPostDateType"=>"Estimate"}, "PrimaryCompletionDateStruct"=>{"PrimaryCompletionDate"=>"June 2003", "PrimaryCompletionDateType"=>"Actual"}}, "OutcomesModule"=>{"PrimaryOutcomeList"=>{"PrimaryOutcome"=>[{"PrimaryOutcomeMeasure"=>"Penalized months of dialysis during the study", "PrimaryOutcomeTimeFrame"=>"1 year post transplant"}]}}, "OversightModule"=>{"OversightHasDMC"=>"Yes"}, "ConditionsModule"=>{"ConditionList"=>{"Condition"=>["End-Stage Renal Disease", "Kidney Transplantation"]}}, "ReferencesModule"=>{"AvailIPDList"=>{"AvailIPD"=>[{"AvailIPDId"=>"SDY355", "AvailIPDURL"=>"http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY355", "AvailIPDType"=>"Individual Participant Data Set", "AvailIPDComment"=>"ImmPort study identifier is SDY355."}, {"AvailIPDId"=>"SDY355", "AvailIPDURL"=>"http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY355", "AvailIPDType"=>"Study Protocol", "AvailIPDComment"=>"ImmPort study identifier is SDY355."}, {"AvailIPDId"=>"SDY355", "AvailIPDURL"=>"http://www.immport.org/immport-open/public/study/study/displayStudyDetail/SDY355", "AvailIPDType"=>"Study summary, -design, -demographics, -lab tests, -study files", "AvailIPDComment"=>"ImmPort study identifier is SDY355."}]}, "SeeAlsoLinkList"=>{"SeeAlsoLink"=>[{"SeeAlsoLinkURL"=>"https://www.niaid.nih.gov/", "SeeAlsoLinkLabel"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, {"SeeAlsoLinkURL"=>"https://www.niaid.nih.gov/about/dait", "SeeAlsoLinkLabel"=>"Division of Allergy, Immunology, and Transplantation (DAIT)"}]}}, "DescriptionModule"=>{"BriefSummary"=>"This study is designed to test the clinical and laboratory observations that suggest IVIG given before and after kidney transplant to patients who are sensitized (highly sensitive) to certain transplant antigens could result in reduced sensitization and reduced rates of kidney rejection.\n\nSome ESRD patients are highly sensitive to certain transplant antigens (foreign substances that activate the immune system) and must wait for a long time before a well-matched kidney becomes available. Transplant rejection is more likely among highly sensitized patients than in patients who are not highly sensitized. There is no proven method to improve a highly-sensitized patient's chances of receiving and keeping a transplanted kidney.", "DetailedDescription"=>"Kidney transplantation is the treatment of choice for patients with end-stage renal disease (ESRD). However, many patients do not receive this treatment due to immune sensitization to HLA antigens. IVIG has been shown to somewhat reduce anti-HLA antibody activity. By blocking this activity, IVIG may make transplants more feasible and increase graft survival in transplant recipients.\n\nPatients are randomized to receive IV infusion of either 2 g/kg (maximum dose 180 g) IVIG 10% S/D (Gamimune-N, 10%, manufactured by Bayer) or placebo (0.1% human albumin, manufactured by Bayer) at time of dialysis at study entry and monthly for 3 months. If patients have not received a transplant at 1 year, they receive a \"booster\" dose of IVIG or placebo; patients receive another booster at 24 months if transplant still has not occurred. If transplant occurs, patients receive 2 g/kg (up to 180 g) IVIG or placebo monthly for 4 months, beginning at time of transplant. Before and after initiation of IVIG/albumin placebo treatment, specific immune parameters, including panel reactive antibodies (PRA) levels, MLR, serum inhibition of MLR, and cytokine gene transcription in the MLR, and AECA levels are measured. Outcomes studied include time on dialysis and graft survival rates."}, "EligibilityModule"=>{"Gender"=>"All", "MinimumAge"=>"12 years", "StdAgeList"=>{"StdAge"=>["Child", "Adult", "Older Adult"]}, "HealthyVolunteers"=>"No", "EligibilityCriteria"=>"Inclusion Criteria\n\nYou may be eligible for this study if you:\n\nAre 12 years of age or older.\nHave end-stage renal disease.\nCurrently receive either hemo- or peritoneal dialysis.\nHave an elevated (> 50%) level of panel reactive antibodies (PRA level) on 3 consecutive monthly tests.\nAgree to practice sexual abstinence or to use effective means of birth control/contraception during the study and for 1 year after.\n\nExclusion Criteria\n\nYou will not be eligible for this study if you:\n\nHave received IVIG for any reason within 6 months prior to enrollment.\nAre HIV positive.\nAre Hepatitis B e-antigen/hepatitis B viral DNA-positive.\nHave selective IgA deficiency or have known antibodies to IgA.\nAre allergic to human immune globulin.\nAre pregnant or breast-feeding."}, "IdentificationModule"=>{"NCTId"=>"NCT00000935", "BriefTitle"=>"An Evaluation of IV Gamma Globulin As a Method to Improve Kidney Transplant Survival in Patients With End-Stage Renal Disease Who Are Highly Sensitized to Transplant Antigens", "Organization"=>{"OrgClass"=>"NIH", "OrgFullName"=>"National Institute of Allergy and Infectious Diseases (NIAID)"}, "OfficialTitle"=>"Evaluation of Intravenous Gamma Globulin (IVIG) As an Agent to Lower Allosensitization and Improve Allograft Survival in Highly-Sensitized Adult End-Stage Renal Disease (ESRD) Patients (IG02)", "OrgStudyIdInfo"=>{"OrgStudyId"=>"DAIT IG02"}}, "ArmsInterventionsModule"=>{"ArmGroupList"=>{"ArmGroup"=>[{"ArmGroupType"=>"Experimental", "ArmGroupLabel"=>"Intravenous Immune Globulin (Human)", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Biological: Intravenous immune globulin (IVIG)"]}}, {"ArmGroupType"=>"Placebo Comparator", "ArmGroupLabel"=>"Intravenous Immune Globulin (Human) Placebo", "ArmGroupInterventionList"=>{"ArmGroupInterventionName"=>["Biological: Intravenous immune globulin (IVIG)"]}}]}, "InterventionList"=>{"Intervention"=>[{"InterventionName"=>"Intravenous immune globulin (IVIG)", "InterventionType"=>"Biological", "InterventionDescription"=>"given at a dose of 20mL/kg Intravenous Immune Globulin (Human) (IVIG 10% solvent/detergent)", "InterventionArmGroupLabelList"=>{"InterventionArmGroupLabel"=>["Intravenous Immune Globulin (Human)", "Intravenous Immune Globulin (Human) Placebo"]}}]}}, "ContactsLocationsModule"=>{"LocationList"=>{"Location"=>[{"LocationZip"=>"20850", "LocationCity"=>"Rockville", "LocationState"=>"Maryland", "LocationCountry"=>"United States", "LocationFacility"=>"Ann Limberger"}]}, "OverallOfficialList"=>{"OverallOfficial"=>[{"OverallOfficialName"=>"Stanley Jordan, MD", "OverallOfficialRole"=>"Principal Investigator", "OverallOfficialAffiliation"=>"Department of Pediatrics, Cedars-Sinai Medical Center"}]}}, "IPDSharingStatementModule"=>{"IPDSharing"=>"Yes", "IPDSharingDescription"=>"Participant level data and additional relevant materials are available to the public in the Immunology Database and Analysis Portal (ImmPort). ImmPort is a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts."}, "SponsorCollaboratorsModule"=>{"LeadSponsor"=>{"LeadSponsorName"=>"National Institute of Allergy and Infectious Diseases (NIAID)", "LeadSponsorClass"=>"NIH"}, "ResponsibleParty"=>{"ResponsiblePartyType"=>"Sponsor"}}}}}}
