Ignite Creation Date:
2025-12-25 @ 2:15 AM
Ignite Modification Date:
2025-12-26 @ 3:58 PM
Study NCT ID:
NCT00929760
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2009-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Specialised Renal Care in Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003643', 'term': 'Death'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2009-06-26', 'studyFirstSubmitQcDate': '2009-06-26', 'lastUpdatePostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary (composite): death, and hospitalisation', 'timeFrame': '24 months after enrollment', 'description': 'death and emergency hospitalisation during the following 2 years afterr andomisation'}], 'secondaryOutcomes': [{'measure': 'Secondary: initiation of urgent RRT, decline of renal residual function at 2 years, decline of quality of life', 'timeFrame': '24 months after enrollment', 'description': 'cf title'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Kidney disease', 'Nephrologists', 'Primary Care', 'Death', 'Renal Replacement Therapy', 'Specialised renal care'], 'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '32272886', 'type': 'DERIVED', 'citation': 'Saudan P, Ponte B, Marangon N, Martinez C, Berchtold L, Jaques D, Ernandez T, de Seigneux S, Carballo S, Perneger T, Martin PY. Impact of superimposed nephrological care to guidelines-directed management by primary care physicians of patients with stable chronic kidney disease: a randomized controlled trial. BMC Nephrol. 2020 Apr 9;21(1):128. doi: 10.1186/s12882-020-01747-3.'}]}, 'descriptionModule': {'briefSummary': 'This is a prospective randomised trial studying patients with stage 3 to 5 chronic kidney disease (CKD) in order to determine the impact of specialised care by nephrologists compared to guidelines-directed management by primary care physicians (PCP) on: a) prognosis (clinical outcome), b) planning of renal replacement therapy (RRT) (urgent versus planned initiation RRT) and c) patient satisfaction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with CKD stage 3, 4 and 5 (CCl \\< 40 ml/min according to abbreviated MDRD formula) aged 18-80 years old and enrolled during a hospitalization.\n\nExclusion Criteria:\n\n* Patients previously known by nephrologists.\n* Estimated life expectancy \\< 1 year\n* Refusal or inability to sign writing consent'}, 'identificationModule': {'nctId': 'NCT00929760', 'acronym': 'IMPLICATE', 'briefTitle': 'Impact of Specialised Renal Care in Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Impact of Specialised Renal Care in Patients With Chronic Kidney Disease Stage 3-5: A Prospective Randomised Study. "The Implicate Study"', 'orgStudyIdInfo': {'id': '08-226'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'nephrologists', 'description': 'Combined management PCP: nephrologists (at least 4 nephrology visits/year)', 'interventionNames': ['Behavioral: specialised renal care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Primary Care Physicians', 'description': 'Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG', 'interventionNames': ['Behavioral: specialised renal care']}], 'interventions': [{'name': 'specialised renal care', 'type': 'BEHAVIORAL', 'description': '* Combined management PCP - nephrologists (at least 4 nephrology visits/year). Agreement of the PCP is required for this combined management.\n* Management by PCPs only, with the help of written instructions from our nephrology unit based on EBPG. Requested Email or over the phone advices to PCPs will be provided by the nephrology division of HUG.', 'armGroupLabels': ['Primary Care Physicians', 'nephrologists']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Geneva', 'state': 'Geneva City', 'country': 'Switzerland', 'facility': 'Nephrology Unit Geneva University Hospitals', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Patrick Saudan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Schweizerische Nierenliga', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, MD', 'investigatorFullName': 'Patrick Saudan', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}