Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-05-22 @ 1:10 PM
Study NCT ID:
NCT06491394
Status:
COMPLETED
Last Update Posted:
2025-07-04
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lactoferrin Effect on Kidney and Heart of Rhabdomyolysis Rats
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012206', 'term': 'Rhabdomyolysis'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007781', 'term': 'Lactoferrin'}, {'id': 'D005990', 'term': 'Glycerol'}], 'ancestors': [{'id': 'D012697', 'term': 'Serine Endopeptidases'}, {'id': 'D010450', 'term': 'Endopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D057057', 'term': 'Serine Proteases'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061250', 'term': 'Transferrins'}, {'id': 'D033862', 'term': 'Iron-Binding Proteins'}, {'id': 'D002352', 'term': 'Carrier Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D007782', 'term': 'Lactoglobulins'}, {'id': 'D000067816', 'term': 'Whey Proteins'}, {'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D008667', 'term': 'Metalloproteins'}, {'id': 'D000073999', 'term': 'Triose Sugar Alcohols'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-03', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-01', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Nrf2 expression', 'timeFrame': '2 months', 'description': 'Nrf2 expression in heart and kidney tissues'}, {'measure': 'AMPK levels', 'timeFrame': '2 months', 'description': 'AMPK levels in kidney and heart tissue homogenate'}, {'measure': 'HO-1 levels', 'timeFrame': '2 months', 'description': 'HO-1 levels in kidney and heart tissue homogenate'}], 'secondaryOutcomes': [{'measure': 'iron levels', 'timeFrame': '2 months', 'description': 'Iron levels in heart and kidney tissue homogenate'}, {'measure': 'MDA levels', 'timeFrame': '2 months', 'description': 'MDA levels in heart and kidney tissue homogenate'}, {'measure': 'TAC levels', 'timeFrame': '2 months', 'description': 'TAC levels in heart and kidney tissue homogenate'}, {'measure': 'GSH levels', 'timeFrame': '2 months', 'description': 'GSH levels in heart and kidney tissue homogenate'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rhabdomyolysis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://pubmed.ncbi.nlm.nih.gov/32601262/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/27161318/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/34860639/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/34091586/', 'label': 'Related Info'}, {'url': 'https://pubmed.ncbi.nlm.nih.gov/35595070/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This study focuses on detecting the possible beneficial effect of Lactoferrin (Lf) administration on the kidney and the heart of glycerol-induced rhabdomyolysis (RM) in rats and its relation to ferroptosis and AMPK/Nrf2/ HO-1 signalling pathway. The main questions it aims to answer are:\n\n1. Is Lf administration 30 min. before or after RM induction in rats beneficial to kidneys and heart?\n2. When administered to glycerol-induced rats, does Lf act by upregulating the AMPK/Nrf2/ HO-1 signalling pathway and inhibiting ferroptosis?'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '12 Weeks', 'minimumAge': '10 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Twenty-four healthy male Wistar Albino rats weighing from 250 to 300 g\n\nExclusion Criteria:\n\n* No exclusion criteria as this study is used to detect effects of drugs on experimental rats.'}, 'identificationModule': {'nctId': 'NCT06491394', 'briefTitle': 'Lactoferrin Effect on Kidney and Heart of Rhabdomyolysis Rats', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Effect of Lactoferrin Administration on Rhabdomyolysis-induced Heart and Kidney Injury in Rats', 'orgStudyIdInfo': {'id': 'Lactoferrin in rhabdomyolysis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Normal saline will be administered once to rats intramuscularly (10 mL/kg).', 'interventionNames': ['Diagnostic Test: iron', 'Diagnostic Test: MDA, TAC, and GSH', 'Diagnostic Test: Nrf2', 'Diagnostic Test: AMPK', 'Diagnostic Test: HO-1']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RM', 'description': 'A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and normal saline (4ml/kg) will be administered by gavage.', 'interventionNames': ['Diagnostic Test: iron', 'Diagnostic Test: MDA, TAC, and GSH', 'Diagnostic Test: Nrf2', 'Diagnostic Test: AMPK', 'Diagnostic Test: HO-1', 'Drug: glycerin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lf-RM', 'description': 'A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. before RM induction', 'interventionNames': ['Drug: Lactoferrin', 'Diagnostic Test: iron', 'Diagnostic Test: MDA, TAC, and GSH', 'Diagnostic Test: Nrf2', 'Diagnostic Test: AMPK', 'Diagnostic Test: HO-1', 'Drug: glycerin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RM-Lf', 'description': 'A single intramuscular injection of GLY 50% (10 mL/kg) after 24-h water deprivation and Lf (1000 mg/kg in normal saline, volume 4 mL/kg) will be administered by gavage 30 min. after RM induction.', 'interventionNames': ['Drug: Lactoferrin', 'Diagnostic Test: iron', 'Diagnostic Test: MDA, TAC, and GSH', 'Diagnostic Test: Nrf2', 'Diagnostic Test: AMPK', 'Diagnostic Test: HO-1', 'Drug: glycerin']}], 'interventions': [{'name': 'Lactoferrin', 'type': 'DRUG', 'description': 'an iron-binding protein', 'armGroupLabels': ['Lf-RM', 'RM-Lf']}, {'name': 'iron', 'type': 'DIAGNOSTIC_TEST', 'description': 'Iron in kidney and heart tissues', 'armGroupLabels': ['Control', 'Lf-RM', 'RM', 'RM-Lf']}, {'name': 'MDA, TAC, and GSH', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Malondialdehyde, Total antioxidant, and glutathione'], 'description': 'Oxidative stress levels in kidney and heart tissues', 'armGroupLabels': ['Control', 'Lf-RM', 'RM', 'RM-Lf']}, {'name': 'Nrf2', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Nuclear factor erythroid 2-related factor 2'], 'description': 'Nrf2 expression in kidney and heart tissues', 'armGroupLabels': ['Control', 'Lf-RM', 'RM', 'RM-Lf']}, {'name': 'AMPK', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Adenosine monophosphate-activated protein kinase'], 'description': 'AMPK levels in heart and kidney tissues', 'armGroupLabels': ['Control', 'Lf-RM', 'RM', 'RM-Lf']}, {'name': 'HO-1', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['heme oxygenase-1'], 'description': 'HO-1 levels in kidney and heart tissues', 'armGroupLabels': ['Control', 'Lf-RM', 'RM', 'RM-Lf']}, {'name': 'glycerin', 'type': 'DRUG', 'otherNames': ['GLY'], 'description': 'GLY intramuscular injection for rhabdomyolysis induction', 'armGroupLabels': ['Lf-RM', 'RM', 'RM-Lf']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'state': 'Aswan Governorate', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Asmaa Abdel-mageed Muhammed', 'investigatorAffiliation': 'Aswan University Hospital'}}}}