Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2025-12-27 @ 9:27 PM
Study NCT ID:
NCT05818995
Status:
UNKNOWN
Last Update Posted:
2024-04-03
First Post:
2023-03-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Drug Use for CKD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003928', 'term': 'Diabetic Nephropathies'}], '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'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000806', 'term': 'Angiotensin-Converting Enzyme Inhibitors'}, {'id': 'D057911', 'term': 'Angiotensin Receptor Antagonists'}, {'id': 'D054873', 'term': 'Dipeptidyl-Peptidase IV Inhibitors'}, {'id': 'D000097789', 'term': 'Glucagon-Like Peptide-1 Receptor Agonists'}, {'id': 'D000077203', 'term': 'Sodium-Glucose Transporter 2 Inhibitors'}, {'id': 'D002121', 'term': 'Calcium Channel Blockers'}], 'ancestors': [{'id': 'D011480', 'term': 'Protease Inhibitors'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D007004', 'term': 'Hypoglycemic Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D049990', 'term': 'Membrane Transport Modulators'}, {'id': 'D000077264', 'term': 'Calcium-Regulating Hormones and Agents'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-02', 'studyFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2023-04-18', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'eGFR', 'timeFrame': 'October , 2023', 'description': 'The current treatment status and medication regimen of CKD patients with different risk stratification were analyzed by GFR staging.'}, {'measure': 'albuminuria', 'timeFrame': 'October , 2023', 'description': 'The current treatment status and medication regimen of CKD patients with different risk stratification were analyzed by albuminuria grading.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chronic kidney disease', 'Diabetes nephropathy', 'Drug effectiveness', 'Drug safety', 'Drug economics'], 'conditions': ['Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'Chronic kidney disease (CKD), characterized as renal dysfunction, is recognized as a major public health problem with high morbidity and mortality worldwide. This study aimed to analyze the common drug use and combinations of different stages and types of CKD patients. The study is a multicenter retrospective study involving three hospitals. Investigators reviewed and analyzed all patients diagnosed with chronic kidney disease from July 1, 2020 to June 30, 2022. Chronic kidney disease was defined as eGFR less than 60 mL/min per 1·73 m(2) or the presence of albuminuria. The study selected seven types of drugs based on hospital electronic medical record data, including β Receptor blockers, angiotensin converting enzyme inhibitor blockers, angiotensin II receptors, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, and calcium channel blockers. Chi-square test, Mann-Whitney Wilcoxon test, and Kruskal Wallis test will be used for statistical analysis. The main purpose of this study is to provide evidence for promoting rational drug use in CKD patients by describing the drug use. The secondary purpose of the study is to explore the efficacy, safety and economy of SGLT-2 inhibitors in diabetes nephropathy (DN).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnosed with chronic kidney disease from July 1, 2020 to June 30, 2022', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Visit time (based on admission time for inpatients) is from July 1, 2020 to June 30, 2022\n2. Any diagnostic type of the patient's visit includes CKD related diagnostics\n3. Age ≥ 18 years old\n\nExclusion Criteria:\n\n1. Diagnosis includes malignant tumors\n2. Diagnosis includes uremia, hemodialysis, or peritoneal dialysis\n3. Diagnosis includes jaundice\n4. Incomplete clinical data"}, 'identificationModule': {'nctId': 'NCT05818995', 'briefTitle': 'Therapeutic Drug Use for CKD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Qianfoshan Hospital'}, 'officialTitle': 'Therapeutic Drug Use in Patients With Chronic Kidney Disease (CKD): a Multicenter Retrospective Real-world Study', 'orgStudyIdInfo': {'id': 'LCYX-LX-20230101'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CKD G1', 'description': 'GFR ≥90 mL/(min·1.73m2)', 'interventionNames': ['Drug: angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker']}, {'label': 'CKD G2', 'description': 'GFR 60\\~89 mL/(min·1.73m2)', 'interventionNames': ['Drug: angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker']}, {'label': 'CKD G3', 'description': 'GFR 30\\~59 mL/(min·1.73m2)', 'interventionNames': ['Drug: angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker']}, {'label': 'CKD G4', 'description': 'GFR 15\\~29 mL/(min·1.73m2)', 'interventionNames': ['Drug: angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker']}, {'label': 'CKD G5', 'description': 'GFR \\<15 mL/(min·1.73m2)', 'interventionNames': ['Drug: angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker']}], 'interventions': [{'name': 'angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blocker', 'type': 'DRUG', 'description': 'Drug types: angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, DPP-4 inhibitors, GLP-1 receptor agonists, SGLT2 inhibitors, calcium channel blockers, β Receptor blockers Treatment prescription: medication alone or in combination Dose used: \\<standard dose, standard dose, \\>standard dose Frequency of administration: once a day, twice a day, three times a day.', 'armGroupLabels': ['CKD G1', 'CKD G2', 'CKD G3', 'CKD G4', 'CKD G5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '250014', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Xiao Li，MD', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qianfoshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor of pharmacy', 'investigatorFullName': 'Xiao Li，MD', 'investigatorAffiliation': 'Qianfoshan Hospital'}}}}