Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2026-02-20 @ 4:33 PM
Study NCT ID:
NCT02808351
Status:
COMPLETED
Last Update Posted:
2022-03-29
First Post:
2016-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'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': 'D001599', 'term': 'Berberine'}], 'ancestors': [{'id': 'D001600', 'term': 'Berberine Alkaloids'}, {'id': 'D044182', 'term': 'Benzylisoquinolines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-26', 'studyFirstSubmitDate': '2016-06-12', 'studyFirstSubmitQcDate': '2016-06-20', 'lastUpdatePostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Contrast-induced nephropathy', 'timeFrame': '72 hours', 'description': 'An absolute increase in serum creatinine (SCr) \\>=0.5mg/dL（\\>=44.2μmmol/L）or a \\>= 25% increase in SCr from baseline to 72 hours after the procedure'}], 'secondaryOutcomes': [{'measure': 'Major adverse renal events', 'timeFrame': '30 days', 'description': 'The composite of hospitalization for aggravated renal function, acute renal failure, dialysis or hemofiltration, aggravated at least 1 class of heart function, acute left ventricular failure or death from all causes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Chronic Kidney Disease']}, 'descriptionModule': {'briefSummary': 'The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced nephropathy (CIN). Major risk factors for CIN include older age, diabetes mellitus (DM), chronic kidney disease(CKD), the concurrent use of nephrotoxic drugs, hemodynamic instability, etc. Importantly, DM appears to act as a risk multiplier, meaning that in a patient with CKD it amplifies the risk of CIAKI.\n\nThe aim of this multicenter prospective, randomized, controlled study is to evaluate whether berberine treatment during and after the perioperative period would reduce the risk of CIN in a high-risk population of patients with both DM and CKD undergoing coronary angiography or noncoronary angiography, and the influence of such potential benefit on short-term outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned diagnostic coronary or peripheral artery angiography\n* Type 2 diabetes mellitus\n* CKD stages ≥2\n* Statin naive, or not on statin treatment for at least 14 days\n* Withdrawal metformin or aminophylline for 48h before angiography\n* Total iodixanol volume\n\nExclusion Criteria:\n\n* Hypersensitivity to iodine-containing compounds and berberine\n* Ketoacidosis\n* Lactic acidosis\n* CKD stages 1, 5 (eGFR≥90ml/min per 1.73m2 or eGFR\\<15ml/min per 1.73m2)\n* STEMI\n* NYHA class IV or hemodynamic instability\n* Administration of any iodinated contrast medium within 14 days before randomization\n* LDL-C\\<1.82mmol/L（70mg/dL）\n* Hepatic dysfunction (ALT 3 times greater than upper normal limit)\n* Thyreoid insufficiency\n* Renal artery Stenosis(unilateral \\>70％ or bilateral stenosis\\>50％)'}, 'identificationModule': {'nctId': 'NCT02808351', 'briefTitle': 'Berberine Prevent Contrast-induced Nephropathy in Patients With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'Multicenter Randomized Controlled Study of Berberine for Prevention of Contrast-Induced Acute Kidney Injury in Patients With Diabetes and Renal Insufficient', 'orgStudyIdInfo': {'id': 'NFH20160611'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Berberine', 'description': 'Preoperative berberine 300 mg administration for at least 6 hours before interventional procedure, post-procedure berberine administration 100 mg at 24, 48 hours after procedure.', 'interventionNames': ['Drug: Berberine']}, {'type': 'NO_INTERVENTION', 'label': 'Blank control', 'description': 'Blank control of berberine administration'}], 'interventions': [{'name': 'Berberine', 'type': 'DRUG', 'armGroupLabels': ['Berberine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Shaoliang Chen', 'role': 'STUDY_CHAIR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Cardiology and Cath Lab, Vice President of Nanjing First Hospital', 'investigatorFullName': 'Shaoliang Chen, MD', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}