Ignite Creation Date:
2025-12-24 @ 3:23 PM
Ignite Modification Date:
2025-12-26 @ 5:29 PM
Study NCT ID:
NCT05774392
Status:
WITHDRAWN
Last Update Posted:
2025-12-17
First Post:
2023-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Observational Study of 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': 'D007676', 'term': 'Kidney Failure, Chronic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'This protocol never enrolled any paticipants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-09', 'studyFirstSubmitDate': '2023-03-07', 'studyFirstSubmitQcDate': '2023-03-07', 'lastUpdatePostDateStruct': {'date': '2025-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To characterize the natural history of disease in patients with CKD/ESKD.', 'timeFrame': '20 Years'}, {'measure': 'To assess safety and effectiveness of CKD/ESKD treatments and treatments for complications of either condition', 'timeFrame': '20 Years'}], 'secondaryOutcomes': [{'measure': 'To evaluate provider management practices in the treatment of patients with CKD/ESKD', 'timeFrame': '20 Years'}, {'measure': 'To evaluate longitudinal and patient reported outcomes in CKD/ESKD', 'timeFrame': '20 Years'}, {'measure': 'To select and evaluate quality of care measures for patients with CKD/ESKD', 'timeFrame': '20 Years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Disease, Chronic', 'End Stage Kidney Disease']}, 'descriptionModule': {'briefSummary': 'TARGET-KIDNEY is an observational research study to conduct a comprehensive review of outcomes for patients with chronic kidney disease (CKD) and end-stage renal disease (ESKD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include adults who are being managed for Stage 1-5 CKD or received a transplant for ESKD.', 'eligibilityCriteria': 'Disease Cohort\n\nInclusion Criteria:\n\n* Adult\\* patients at the time of enrollment with a diagnosis of CKD/ESKD by ICD-10 code in the EHR interface\n\nExclusion Criteria:\n\n* Death\n* Manual removal (sponsor or site request)\n* No EHR interface encounter \\> 3 years\n\nEngaged Cohort\n\nInclusion Criteria:\n\n* Adult \\* patients diagnosed and managed for CKD/ESKD invited to participate\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Patient expressed desire to withdraw consent to complete PROs\n* Failure to complete PROs within 24 weeks of initial invitation\n* Greater than 24 months lapse of survey completion after baseline surveys completed\n* Additionally, the criteria detailed for Disease Cohort apply to the Engaged Cohort'}, 'identificationModule': {'nctId': 'NCT05774392', 'briefTitle': 'An Observational Study of Patients With Chronic Kidney Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Target PharmaSolutions, Inc.'}, 'officialTitle': 'An Observational Study of Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'TARGET-KIDNEY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Disease Cohort', 'interventionNames': ['Other: Observational']}, {'label': 'Engaged Cohort', 'interventionNames': ['Other: Observational']}], 'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'Observational', 'armGroupLabels': ['Disease Cohort', 'Engaged Cohort']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Target PharmaSolutions, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}