Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-01 @ 7:29 PM
Study NCT ID:
NCT05284656
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-06-11
First Post:
2022-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005492', 'term': 'Folic Acid'}, {'id': 'D010431', 'term': 'Pentoxifylline'}], 'ancestors': [{'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'amira.reda89@hotmail.com', 'phone': '0106 822 0389', 'title': 'Amira Reda Muhammad', 'organization': 'Al-Azhar University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'patient are followed up for 6 months for any adverse events', 'description': 'the drug is safe and approved by FDA and the assessment of adverse event was collected based on weekly questionnaire', 'eventGroups': [{'id': 'EG000', 'title': 'Folic Acid Group', 'description': '20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months.\n\nfolic acid: drugs used to delay progression of chronic kidney disease', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Pentoxifylline Group', 'description': '20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months.\n\nPentoxifylline 400 MG: drugs used to delay progression of chronic kidney disease', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Folic Acid and Pentoxifylline Group', 'description': '20 patients will receive combination therapy of folic acid5 mg per day and pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months\n\ncombination of Pentoxifylline 400 MG and Folic Acid: drugs used to delay progression of chronic kidney disease', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Control Group', 'description': '20 patients will receive their standard therapy only.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Serum Creatinine Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid Group', 'description': '20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months.\n\nfolic acid: drugs used to delay progression of chronic kidney disease'}, {'id': 'OG001', 'title': 'Pentoxifylline Group', 'description': '20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months.\n\nPentoxifylline 400 MG: drugs used to delay progression of chronic kidney disease'}, {'id': 'OG002', 'title': 'Folic Acid and Pentoxifylline Group', 'description': '20 patients will receive combination therapy of folic acid5 mg per day and pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months\n\ncombination of Pentoxifylline 400 MG and Folic Acid: drugs used to delay progression of chronic kidney disease'}, {'id': 'OG003', 'title': 'Control Group', 'description': '20 patients will receive their standard therapy only.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.118', 'spread': '1.203', 'groupId': 'OG000'}, {'value': '3.335', 'spread': '1.149', 'groupId': 'OG001'}, {'value': '3.535', 'spread': '0.9109', 'groupId': 'OG002'}, {'value': '2.872', 'spread': '0.8901', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 months', 'description': 'Change was calculated as the value at 6 months minus the value at baseline.', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Serum Ferritin in ng/ml', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Folic Acid Group', 'description': '20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months.\n\nfolic acid: drugs used to delay progression of chronic kidney disease'}, {'id': 'OG001', 'title': 'Pentoxifylline Group', 'description': '20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months.\n\nPentoxifylline 400 MG: drugs used to delay progression of chronic kidney disease'}, {'id': 'OG002', 'title': 'Folic Acid and Pentoxifylline Group', 'description': '20 patients will receive combination therapy of folic acid5 mg per day and pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months\n\ncombination of Pentoxifylline 400 MG and Folic Acid: drugs used to delay progression of chronic kidney disease'}, {'id': 'OG003', 'title': 'Control Group', 'description': '20 patients will receive their standard therapy only.'}], 'classes': [{'categories': [{'measurements': [{'value': '200.6', 'spread': '66.18', 'groupId': 'OG000'}, {'value': '334.1', 'spread': '230.2', 'groupId': 'OG001'}, {'value': '245.1', 'spread': '115.7', 'groupId': 'OG002'}, {'value': '235.3', 'spread': '185.1', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'increase in serum ferritin from baseline', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Protein/ Creatinine Ratio(P/C) (mg Protein/mg Creatinine)', 'timeFrame': '6 months', 'description': 'change in Protein/ creatinine ratio for determination of proteinuria', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2025-12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Folic Acid Group', 'description': '20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months.\n\nfolic acid: drugs used to delay progression of chronic kidney disease'}, {'id': 'FG001', 'title': 'Pentoxifylline Group', 'description': '20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months.\n\nPentoxifylline 400 MG: drugs used to delay progression of chronic kidney disease'}, {'id': 'FG002', 'title': 'Folic Acid and Pentoxifylline Group', 'description': '20 patients will receive combination therapy of folic acid5 mg per day and pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months\n\ncombination of Pentoxifylline 400 MG and Folic Acid: drugs used to delay progression of chronic kidney disease'}, {'id': 'FG003', 'title': 'Control Group', 'description': '20 patients will receive their standard therapy only.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'some patient are excluded from the study as they donnot meet the inclusion criteria'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Folic Acid Group', 'description': '20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months.\n\nfolic acid: drugs used to delay progression of chronic kidney disease'}, {'id': 'BG001', 'title': 'Folic Acid and Pentoxifylline Group', 'description': '20 patients will receive combination therapy of folic acid5 mg per day and pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months\n\ncombination of Pentoxifylline 400 MG and Folic Acid: drugs used to delay progression of chronic kidney disease'}, {'id': 'BG002', 'title': 'Pentoxifylline Group', 'description': '20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months.\n\nPentoxifylline 400 MG: drugs used to delay progression of chronic kidney disease'}, {'id': 'BG003', 'title': 'Control Group', 'description': '20 patients will receive their standard therapy only.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '52.25', 'spread': '6.64', 'groupId': 'BG000'}, {'value': '51.80', 'spread': '6.7', 'groupId': 'BG001'}, {'value': '52.20', 'spread': '7.2', 'groupId': 'BG002'}, {'value': '51.6', 'spread': '6.6', 'groupId': 'BG003'}, {'value': '51.96', 'spread': '6.78', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'glomular filtration rate', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '80', 'groupId': 'BG004'}]}], 'categories': [{'measurements': [{'value': '22.15', 'spread': '11.12', 'groupId': 'BG000'}, {'value': '17.25', 'spread': '7.217', 'groupId': 'BG001'}, {'value': '17.85', 'spread': '8.6', 'groupId': 'BG002'}, {'value': '21.87', 'spread': '9.7', 'groupId': 'BG003'}, {'value': '19.78', 'spread': '9.15', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'glomular filtration rate is measured from serum creatinine to measure kidney function', 'unitOfMeasure': 'ml/min', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2025-06-10', 'size': 190633, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-06-10T04:59', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2022-02-16', 'resultsFirstSubmitDate': '2023-06-21', 'studyFirstSubmitQcDate': '2022-03-09', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-10', 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Protein/ Creatinine Ratio(P/C) (mg Protein/mg Creatinine)', 'timeFrame': '6 months', 'description': 'change in Protein/ creatinine ratio for determination of proteinuria'}], 'primaryOutcomes': [{'measure': 'Change in Serum Creatinine Level', 'timeFrame': 'Baseline, 6 months', 'description': 'Change was calculated as the value at 6 months minus the value at baseline.'}], 'secondaryOutcomes': [{'measure': 'Serum Ferritin in ng/ml', 'timeFrame': '6 months', 'description': 'increase in serum ferritin from baseline'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Diseases']}, 'referencesModule': {'references': [{'pmid': '40826392', 'type': 'DERIVED', 'citation': 'Galal ARM, Teama NM, Abu-Elfotuha K, Alatawi AD, Alshareef H, Hamdan AME, Aljabri A, Alshibani M, Zalat ZAM. The potential adding therapeutic effect of pentoxifylline and/or folic acid for chronic kidney disease patients: randomized controlled trial. BMC Nephrol. 2025 Aug 18;26(1):468. doi: 10.1186/s12882-025-04399-3.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of administration of folic acid and /or pentoxifylline on patients with chronic kidney disease (CKD).', 'detailedDescription': 'Chronic kidney disease (CKD) is a worldwide public health problem, with adverse outcomes of kidney failure, cardiovascular disease (CVD), and premature death. Chronic kidney disease (CKD) affects between 8% and 16% of the population worldwide.Defined by a glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m2, albuminuria of at least 30 mg per 24 hours, or markers of kidney damage (eg, hematuria or structural abnormalities such as polycystic or dysplastic kidneys) persisting for more than 3 months.That nutrient loss because of diet restriction and chronic inflammation contributed by CKD itself may stimulate progression in advanced chronic kidney disease. Folic acid was then selected as a nutrient intervention. In the mean time, pentoxifylline was well studied in this field for its anti-inflammatory effects.Pentoxifylline (PTF) appears to improve circulation through its ability to alter erythrocyte deformability and enhances capillary microcirculation. This hemorheological property and the potential capacity in decreasing intraglomerular pressure has led to recent interest in PTF as a therapeutic agent in patients with kidney disease. In addition to these properties, PTF has an effect on inflammation, oxidative stress and endothelial function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who have chronic kidney disease(CKD) stages 3-5\n2. Aged between18 - 60 years old.\n3. Both sexes.\n4. Stable clinical condition defined as no hospitalizations or cardiovascular events within the 3 months before screening\n5. Stable renal function (baseline serum creatinine had to have not increased by 50% in the 3 months before screening)\n6. No changes in concomitant medication during the study.\n7. Patients who accept to participate in the study.\n\nExclusion Criteria:\n\n1. Pregnant women\n2. Current use of PTF\n3. Contraindication to use of PTF drug: history of PTF or theophylline allergy, history of severe retinal hemorrhage or recent cerebral hemorrhage\n4. Those with active infections or inflammatory diseases or HIV infection\n5. Those with chronic liver disease .\n6. Patients who had received immunosuppressive therapy\n7. Non-compliant patients'}, 'identificationModule': {'nctId': 'NCT05284656', 'briefTitle': 'Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'The Potential Nephro-protective Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'Interventional'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'folic acid Group', 'description': '20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months.', 'interventionNames': ['Drug: folic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Pentoxifylline Group', 'description': '20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months.', 'interventionNames': ['Drug: Pentoxifylline 400 MG']}, {'type': 'EXPERIMENTAL', 'label': 'folic acid and pentoxifylline Group', 'description': '20 patients will receive combination therapy of folic acid5 mg per day and pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months', 'interventionNames': ['Drug: combination of Pentoxifylline 400 MG and Folic Acid']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': '20 patients will receive their standard therapy only.'}], 'interventions': [{'name': 'combination of Pentoxifylline 400 MG and Folic Acid', 'type': 'DRUG', 'otherNames': ['combination of Trental SR 400mg and Folic acid'], 'description': 'drugs used to delay progression of chronic kidney disease', 'armGroupLabels': ['folic acid and pentoxifylline Group']}, {'name': 'folic acid', 'type': 'DRUG', 'description': 'drugs used to delay progression of chronic kidney disease', 'armGroupLabels': ['folic acid Group']}, {'name': 'Pentoxifylline 400 MG', 'type': 'DRUG', 'otherNames': ['Trental SR 400mg'], 'description': 'drugs used to delay progression of chronic kidney disease', 'armGroupLabels': ['Pentoxifylline Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Al Azhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Zeinab AlKasaby', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor and Head of Clinical Pharmacy Department, Faculty of Pharmacy (Girls), Al-Azhar University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Amira Reda Muhammad Galal', 'investigatorAffiliation': 'Al-Azhar University'}}}}