Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-03-02 @ 4:24 PM
Study NCT ID:
NCT02278159
Status:
COMPLETED
Last Update Posted:
2014-10-29
First Post:
2014-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Integrated Home Dialysis Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010530', 'term': 'Peritoneal Dialysis'}, {'id': 'D006437', 'term': 'Hemodialysis, Home'}], 'ancestors': [{'id': 'D006435', 'term': 'Renal Dialysis'}, {'id': 'D017582', 'term': 'Renal Replacement Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}, {'id': 'D006699', 'term': 'Home Care Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-27', 'studyFirstSubmitDate': '2014-06-19', 'studyFirstSubmitQcDate': '2014-10-27', 'lastUpdatePostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Home dialysis survival, case-control analysis', 'timeFrame': 'survival analysis, specific analysis at 1,2 5 years after dialysis initiation', 'description': 'Case-control analysis will be performed in order to address immortal bias in patients classified in the "switching"categories (PD-HHD or HHD-PD). Since we expect the HHD-PD group to be small, this analysis will be performed only with the 3 other groups (PD-HHD, PD only and HHD only). Patients treated successively with PD and HHD (cases) will be matched (by age and diabetes status) to patient treated with PD only and HHD only (controls).'}], 'primaryOutcomes': [{'measure': 'Home dialysis survival', 'timeFrame': 'Survival analysis; specific analysis at 5 years after dialysis initiation', 'description': 'Time to first patient death or home dialysis technique failure for each home dialysis modalities, censored for transplantation and loss to follow-up'}], 'secondaryOutcomes': [{'measure': 'Patient survival, censored for technique failure', 'timeFrame': 'Survival analysis, specific analysis at 1,2 5 years after dialysis initiation', 'description': 'Patient survival on each specific home dialysis modality, censored for technique failure, transplantation and loss to follow-up'}, {'measure': 'Home technique survival, censored for death', 'timeFrame': 'survival analysis, specific analysis at 1,2 5 years after dialysis initiation', 'description': 'Home dialysis technique survival for each home dialysis modality, censored for patient death, transplantation and loss to follow-up'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['end-stage kidney disease', 'peritoneal dialysis', 'home hemodialysis', 'technique survival', 'patient survival'], 'conditions': ['Kidney Failure, Chronic']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate which home dialysis modality pattern (home hemodialysis \\[HHD\\], peritoneal dialysis \\[PD\\] or a combination of both, e.g. PD and then HHD) allows for the longest home dialysis survival, as defined by the time dialysed in a home environment. The investigators hypothesize that patients transferred from one home modality to another will have a longer home dialysis survival compared to patients treated only with PD or HHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with home dialysis as the first renal replacement therapy \\[RRT\\] modality (defined by the dialysis modality at 90 days) in Australia and New Zealand as reported in Australia and New Zealand Dialysis and Transplant Registry \\[ANZDATA\\]', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with PD/HHD 90 days after RRT initiation between January 1, 2000 and December 31, 2012 reported in ANZDATA\n* ≥ 18 years\n\nExclusion Criteria:\n\n* Less than 90 days of dialysis\n* \\< 18 years\n* Patients transferred to Australia/New Zealand after initiation of dialysis in another country'}, 'identificationModule': {'nctId': 'NCT02278159', 'briefTitle': 'Evaluation of the Integrated Home Dialysis Model', 'organization': {'class': 'OTHER', 'fullName': 'Princess Alexandra Hospital, Brisbane, Australia'}, 'orgStudyIdInfo': {'id': 'ANZ41367'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Peritoneal dialysis only', 'description': 'Patient on PD modality 90 days after renal replacement therapy initiation and not transferred to HHD', 'interventionNames': ['Procedure: Peritoneal dialysis']}, {'label': 'Home hemodialysis only', 'description': 'Patient on HHD 90 days after renal replacement therapy initiation and not transferred to PD', 'interventionNames': ['Procedure: Home hemodialysis']}, {'label': 'PD and HHD', 'description': 'Patient on PD 90 days after RRT initiation and transferred to HHD less than 90 days after PD failure', 'interventionNames': ['Procedure: Peritoneal dialysis', 'Procedure: Home hemodialysis']}, {'label': 'HHD and PD', 'description': 'Patient on HHD after RRT initiation and transferred to PD less than 90 days after HHD failure', 'interventionNames': ['Procedure: Peritoneal dialysis', 'Procedure: Home hemodialysis']}], 'interventions': [{'name': 'Peritoneal dialysis', 'type': 'PROCEDURE', 'armGroupLabels': ['HHD and PD', 'PD and HHD', 'Peritoneal dialysis only']}, {'name': 'Home hemodialysis', 'type': 'PROCEDURE', 'armGroupLabels': ['HHD and PD', 'Home hemodialysis only', 'PD and HHD']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Princess Alexandra Hospital, Brisbane, Australia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Metro South and Ipswich Nephrology and Transplant Services (MINTS) Medical Director, Queensland Renal Transplant Services Professor of Medicine (University of Qld)', 'investigatorFullName': 'David Johnson', 'investigatorAffiliation': 'Princess Alexandra Hospital, Brisbane, Australia'}}}}