Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-03-03 @ 6:05 PM
Study NCT ID:
NCT03800433
Status:
UNKNOWN
Last Update Posted:
2019-09-25
First Post:
2019-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pentoxifylline Administration in Hemodialysis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010431', 'term': 'Pentoxifylline'}], 'ancestors': [{'id': 'D013805', 'term': 'Theobromine'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 46}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2019-01-09', 'studyFirstSubmitQcDate': '2019-01-10', 'lastUpdatePostDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference in hemoglobin and hematocrit concentration between the intervention and control groups at the end of the study', 'timeFrame': 'up to 6 months post baseline', 'description': 'Patients will be evaluated regularly every month for hemoglobin concentration'}, {'measure': 'safety & tolerability of pentoxifylline ( frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline).', 'timeFrame': 'up to 6 months post baseline', 'description': 'Patients will be evaluated regularly for frequency of adverse drug effects due to Pentoxifylline as well as compliance with pentoxifylline'}], 'secondaryOutcomes': [{'measure': 'Inflammatory markers TNF-a, IL-1β.', 'timeFrame': 'up to 6 months post baseline', 'description': 'patient will be subjected to laboratory evaluation for estimation of IL-1β,TNF-α levels at baseline as well as end of study evaluation'}, {'measure': 'Difference in the dosage of erythropoiesis stimulating agents.', 'timeFrame': 'up to 6 months post baseline', 'description': 'the dose of ESA will be assessed at end of study evaluation'}, {'measure': 'The ESA ( erythropoiesis stimulating agents)resistance index (ERI).', 'timeFrame': 'up to 6 months post baseline', 'description': 'ERI will be assessed for patients by determining ESA dose and hemoglobin concentration'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pentoxifylline'], 'conditions': ['Anemia Renal']}, 'referencesModule': {'references': [{'pmid': '15758012', 'type': 'BACKGROUND', 'citation': 'Weiss G, Goodnough LT. Anemia of chronic disease. N Engl J Med. 2005 Mar 10;352(10):1011-23. doi: 10.1056/NEJMra041809. No abstract available.'}, {'pmid': '17635745', 'type': 'BACKGROUND', 'citation': 'Johnson DW, Pollock CA, Macdougall IC. Erythropoiesis-stimulating agent hyporesponsiveness. Nephrology (Carlton). 2007 Aug;12(4):321-30. doi: 10.1111/j.1440-1797.2007.00810.x.'}, {'pmid': '15213276', 'type': 'BACKGROUND', 'citation': 'Cooper A, Mikhail A, Lethbridge MW, Kemeny DM, Macdougall IC. Pentoxifylline improves hemoglobin levels in patients with erythropoietin-resistant anemia in renal failure. J Am Soc Nephrol. 2004 Jul;15(7):1877-82. doi: 10.1097/01.asn.0000131523.17045.56.'}, {'pmid': '20470305', 'type': 'BACKGROUND', 'citation': 'Ferrari P, Mallon D, Trinder D, Olynyk JK. Pentoxifylline improves haemoglobin and interleukin-6 levels in chronic kidney disease. Nephrology (Carlton). 2010 Apr;15(3):344-9. doi: 10.1111/j.1440-1797.2009.01203.x.'}, {'pmid': '22241639', 'type': 'BACKGROUND', 'citation': 'Goicoechea M, Garcia de Vinuesa S, Quiroga B, Verdalles U, Barraca D, Yuste C, Panizo N, Verde E, Munoz MA, Luno J. Effects of pentoxifylline on inflammatory parameters in chronic kidney disease patients: a randomized trial. J Nephrol. 2012 Nov-Dec;25(6):969-75. doi: 10.5301/jn.5000077.'}, {'pmid': '26023017', 'type': 'BACKGROUND', 'citation': 'Ogawa T, Nitta K. Erythropoiesis-stimulating agent hyporesponsiveness in end-stage renal disease patients. Contrib Nephrol. 2015;185:76-86. doi: 10.1159/000380972. Epub 2015 May 19.'}, {'pmid': '28487874', 'type': 'BACKGROUND', 'citation': 'Shahbazian H, Ghorbani A, Zafar-Mohtashami A, Balali A, AleAli A, Lashkarara GR. Administration of pentoxifylline to improve anemia of hemodialysis patients. J Renal Inj Prev. 2016 Nov 26;6(1):61-64. doi: 10.15171/jrip.2017.11. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the impact of pentoxifylline administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis patients', 'detailedDescription': 'this is a prospective, randomized, controlled study to assess the impact of pentoxifylline administration on the modulation of hyporesponsiveness to erythropoietin stimulating agents in hemodialysis patients by determining several outcomes from the intervention and control groups at the end of the study.These outcomes include;the difference in hemoglobin and hematocrit concentration , the difference in inflammatory markers tumor necrosis factor Alpha (TNF-α), interleukin-1 Beta (IL-1β),the difference in the dosage of erythropoiesis stimulating agents ,and The erythropoietin stimulating agents (ESA) resistance index (ERI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (18 years or over).\n* Stable hemodialysis \\>6 months.\n* Regular haemodialysis (3 times/ week).\n* ESA resistant anemia (Hb \\<10 mg/dl for 6 mo.).\n* ESA dose of \\>8000 IU/wk.\n\nExclusion Criteria:\n\n* Inadequate hemodialysis.\n* Hyperparathyroidism (PTH\\>800 pg/l).\n* Known hypersensitivity to, or intolerance of Pentoxifylline.\n* Absolute or functional iron deficiency (ferritin \\< 100 μg/L and/or transferrin saturation \\< 20%).\n* Presence of systemic haematological disease (including antibody-mediated pure red cell aplasia) or known haemoglobinopathy.\n* Major surgery, infection, inflammatory diseases, acute myocardial infarction or malignancy within the last 3 months.\n* Patients with chronic liver disease and patients who had received immunosuppressive therapy.'}, 'identificationModule': {'nctId': 'NCT03800433', 'briefTitle': 'Pentoxifylline Administration in Hemodialysis Patients', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Impact of Pentoxifylline Administration on the Modulation of Hyporesponsiveness to Erythropoietin Stimulating Agents in Hemodialysis Patients', 'orgStudyIdInfo': {'id': 'pentoxifylline in hemodialysis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control', 'description': '23 patients will receive their usual dose of erythropoietin stimulating agents and their routine treatment.'}, {'type': 'EXPERIMENTAL', 'label': 'test', 'description': '23 patients will receive the intervention drug Pentoxifylline (Trental 400 milligram(MG) Extended Release Oral Tablet) twice daily in addition their usual dose of erythropoietin stimulating agents and their routine treatment.', 'interventionNames': ['Drug: Trental 400 MG Extended Release Oral Tablet']}], 'interventions': [{'name': 'Trental 400 MG Extended Release Oral Tablet', 'type': 'DRUG', 'description': 'oral tablets', 'armGroupLabels': ['test']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Radwa M Elmetwaly, Bachelor', 'role': 'CONTACT', 'email': 'radwa_mohm@yahoo.com', 'phone': '00201065371016'}], 'overallOfficials': [{'name': 'Lamia El Wakeel, Ass.Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ass.prof clinical pharmacy'}, {'name': 'Radwa El Borolossy, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of clinical pharmacy'}, {'name': 'Magdy ElSharkawy, Prof.Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prof. of nephrology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Post grad', 'investigatorFullName': 'Radwa Mohamed Elmetwaly', 'investigatorAffiliation': 'Ain Shams University'}}}}