Ignite Creation Date:
2025-12-25 @ 4:51 AM
Ignite Modification Date:
2026-03-04 @ 9:36 PM
Study NCT ID:
NCT02481518
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2015-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008274', 'term': 'Magnesium'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D008673', 'term': 'Metals, Alkaline Earth'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D019565', 'term': 'Metals, Light'}, {'id': 'D008670', 'term': 'Metals'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-18', 'studyFirstSubmitDate': '2015-05-17', 'studyFirstSubmitQcDate': '2015-06-24', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute kidney injury', 'timeFrame': '7 days after cisplatin administration', 'description': 'Comparing serum creatinine before Cisplatin treatment and seven days after cisplatin treatment'}], 'secondaryOutcomes': [{'measure': 'Nephrotoxicity', 'timeFrame': 'up to 12 weeks', 'description': 'Compare serum creatinine before Cisplatin treatment and complete 7 cycles of cisplatin treatment ( up to 12 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cisplatin nephrotoxicity', 'Acute kidney injury'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether magnesium preloading reduce incident of cisplatin induced acute kidney injury in head and neck cancer who receiving low dose cisplatin (40 mg/m2 weekly for 7 weeks).', 'detailedDescription': 'Randomized controlled trial comparing efficacy of magnesium preloading versus normal saline for prevention of acute and chronic nephrotoxicity of cisplatin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years\n* Eastern Cooperative Oncology Group score 0-2\n* First Diagnosed Head and neck cancer and plan for treatment with cisplatin\n* Serum creatinine ≤1.5 mg/dl or eGFR≥60(ml/min/1.73 m2)\n\nExclusion Criteria:\n\n* Prior treatment with cisplatin before randomization\n* Uncontrolled concurrent disease\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02481518', 'acronym': 'PRAGMATIC', 'briefTitle': 'Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity', 'orgStudyIdInfo': {'id': '2558/172'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnesium', 'description': 'Magnesium preloading group : Magnesium preloading for Cisplatin treatment', 'interventionNames': ['Drug: Magnesium']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control group : Normal saline preloading for cisplatin treatment', 'interventionNames': ['Other: Control']}], 'interventions': [{'name': 'Magnesium', 'type': 'DRUG', 'description': 'Pre loading fluid with Magnesium sulphate 16 milliequivalent plus potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration', 'armGroupLabels': ['Magnesium']}, {'name': 'Control', 'type': 'OTHER', 'otherNames': ['Normal saline'], 'description': 'Potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of medicine, Ramathibodi Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Arkom Nongnuch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ramathibodi hospital, Mahidol university'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}