Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-01-22 @ 1:20 PM
Study NCT ID:
NCT02455960
Status:
UNKNOWN
Last Update Posted:
2015-05-28
First Post:
2015-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protective Effects of Oral L-Arginine CI-AKI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001120', 'term': 'Arginine'}], 'ancestors': [{'id': 'D024361', 'term': 'Amino Acids, Basic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000599', 'term': 'Amino Acids, Diamino'}, {'id': 'D000601', 'term': 'Amino Acids, Essential'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 112}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-27', 'studyFirstSubmitDate': '2015-05-25', 'studyFirstSubmitQcDate': '2015-05-27', 'lastUpdatePostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Contrast-induced acute kidney injury (CI-AKI)', 'timeFrame': '48 hours'}], 'secondaryOutcomes': [{'measure': 'Number of Adverse effects', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Contrast Induced AKI']}, 'descriptionModule': {'briefSummary': 'This trial was performed to examine the efficacy of oral L-arginine for preventing CI-AKI in chronic kidney disease (CKD) patients.', 'detailedDescription': 'Contrast-induced acute kidney injury (CI-AKI) is a common complication in hospitalized patients. Nitric oxide-signal transduction plays an important role in prevention of CI-AKI. L-Arginine is an amino acid involved in ammonia detoxification, and is well known as a precursor to nitric oxide, a key component of endothelial-derived relaxing factor.\n\nThis is a prospective randomized, double blind, placebo controlled trial among CKD stage 3-4 patients undergoing computer tomography. Eligible patients were randomly assigned to two groups: (1) arginine 3 g/day or 6 capsules per day, and (2) placebo 6 capsules per day for 3 days before contrast media injection. Serum cystatin C, serum creatinine and estimated GFR was measured at baseline and 48 hours after procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Stable CKD stage 3-4 patients\n* Patients undergoing elective contrast media injection\n\nExclusion Criteria:\n\n* History of arginine allergy\n* Acute kidney injury diagnosed within 4 weeks\n* Active infection/sepsis\n* Severe liver disease'}, 'identificationModule': {'nctId': 'NCT02455960', 'briefTitle': 'Protective Effects of Oral L-Arginine CI-AKI', 'organization': {'class': 'OTHER', 'fullName': 'Phramongkutklao College of Medicine and Hospital'}, 'officialTitle': 'Protective Effects of Oral L-Arginine Supplement in Patients With CKD After Intravenous Contrast Media Injection', 'orgStudyIdInfo': {'id': 'Arginine 01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arginine', 'description': 'Participants need to take arginine 3 g/day orally for 3 days before CT with contrast media injection', 'interventionNames': ['Dietary Supplement: L-arginine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants need to take placebo (corn powder) 3 g/day orally for 3 days before CT with contrast media injection', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'L-arginine', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Comparison of the efficacy of L-arginine 3 grams for days versus placebo in contrast induced AKI prevention', 'armGroupLabels': ['Arginine']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Rachatevee', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Nuttawut Siritaweesuk, MD.', 'role': 'CONTACT', 'email': 'znak.iiz@gmaill.com', 'phone': '66819019191'}, {'name': 'Nuttawut Siritaweesuk, MD.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Division of Nephrology, Phramongkutklao Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Phramongkutklao College of Medicine and Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}