Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-02-18 @ 1:50 AM
Study NCT ID:
NCT02530359
Status:
UNKNOWN
Last Update Posted:
2015-08-21
First Post:
2015-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pirfenidone Effect on the Recovery of Renal Function in Septic Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-09-17', 'releaseDate': '2021-08-24'}], 'estimatedResultsFirstSubmitDate': '2021-08-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D018805', 'term': 'Sepsis'}], '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': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-08-19', 'studyFirstSubmitDate': '2015-06-17', 'studyFirstSubmitQcDate': '2015-08-19', 'lastUpdatePostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'renal function recovery', 'timeFrame': 'within the first 7 days', 'description': 'serum creatinine in serum \\<2mg/dl and urinary output \\>1,200 ml/day'}, {'measure': 'renal function recovery', 'timeFrame': 'within the first 28 days', 'description': 'serum creatinine in serum \\<2mg/dl and urinary output \\>1,200ml/day'}], 'secondaryOutcomes': [{'measure': 'Urinary Volume', 'timeFrame': 'within the first 7 days', 'description': 'Urinary Volume in milliliters in 24 hours'}, {'measure': 'need of renal replacement therapy (RRT)', 'timeFrame': 'within the first 7 days', 'description': 'the patient still need renal replacement (RRT) by the judgment of the nephrologist.'}, {'measure': 'mortality', 'timeFrame': 'within the first 7 days', 'description': 'the patient dead'}, {'measure': 'serum creatinine levels', 'timeFrame': 'within the first 7 days', 'description': 'serum creatinine levels in mg/dL'}, {'measure': 'serum urea levels', 'timeFrame': 'within the first 7 days', 'description': 'serum urea levels in mg/dL'}, {'measure': 'pirfenidone levels in serum ug/mL', 'timeFrame': 'on day 1 and day 7', 'description': 'pirfenidone levels in serum ug/mL'}, {'measure': 'IL-1', 'timeFrame': 'on day 1 and day 7', 'description': 'Interleucin 1 in serum pg/mL'}, {'measure': 'IL-6', 'timeFrame': 'on day 1 and day 7', 'description': 'Interleucin 6 in serum pg/mL'}, {'measure': 'TNF-α', 'timeFrame': 'on day 1 and day 7', 'description': 'tumor necrosis factor in serum pg/dL'}, {'measure': 'Toll-like receptor 4', 'timeFrame': 'on day 1 and day 7', 'description': 'Toll-like receptor 4 in serum pg/dL'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['septic acute kidney injury', 'pirfenidone'], 'conditions': ['Acute Kidney Injury', 'Sepsis']}, 'referencesModule': {'references': [{'pmid': '20813868', 'type': 'BACKGROUND', 'citation': 'Hsu CY. 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Surviving sepsis campaign: international guidelines for management of severe sepsis and septic shock: 2012. Crit Care Med. 2013 Feb;41(2):580-637. doi: 10.1097/CCM.0b013e31827e83af.'}, {'pmid': '19066848', 'type': 'BACKGROUND', 'citation': 'Bagshaw SM, Lapinsky S, Dial S, Arabi Y, Dodek P, Wood G, Ellis P, Guzman J, Marshall J, Parrillo JE, Skrobik Y, Kumar A; Cooperative Antimicrobial Therapy of Septic Shock (CATSS) Database Research Group. Acute kidney injury in septic shock: clinical outcomes and impact of duration of hypotension prior to initiation of antimicrobial therapy. Intensive Care Med. 2009 May;35(5):871-81. doi: 10.1007/s00134-008-1367-2. Epub 2008 Dec 9.'}, {'pmid': '21734090', 'type': 'BACKGROUND', 'citation': 'Plataki M, Kashani K, Cabello-Garza J, Maldonado F, Kashyap R, Kor DJ, Gajic O, Cartin-Ceba R. Predictors of acute kidney injury in septic shock patients: an observational cohort study. Clin J Am Soc Nephrol. 2011 Jul;6(7):1744-51. doi: 10.2215/CJN.05480610.'}, {'pmid': '33520317', 'type': 'DERIVED', 'citation': 'Chavez-Iniguez JS, Poo JL, Ibarra-Estrada M, Garcia-Benavides L, Navarro-Blackaller G, Cervantes-Sanchez C, Nungaray-Pacheco E, Medina-Gonzalez R, Armendariz-Borunda J, Garcia-Garcia G. Effect of Prolonged-Release Pirfenidone on Renal Function in Septic Acute Kidney Injury Patients: A Double-Blind Placebo-Controlled Clinical Trial. Int J Nephrol. 2021 Jan 13;2021:8833278. doi: 10.1155/2021/8833278. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'Patients with Septic AKI will be randomized in three arms, group PFD 1,200 will receive PDF 600mg every 12 hrs per mouth, group PDF 600 will receive PFD 600mg in the morning and placebo equivalent at night and Group Placebo will receive placebo every 12 hrs, all for 7 days, all receive conventional treatment KDIGO guides. We analyze the recovery of renal function as a primary objective.', 'detailedDescription': 'Septic acute kidney injury (AKI) is the most common cause of AKI in the world, there is no specific treatment for this pathology; the pathophysiology is related to inflammatory pathway and strategies that modulate this are potentially useful. The Pirfenidone (PDF) is an anti-fibrotic and anti-inflammatory treatment, in animal models has shown a beneficial effect on the recovery of renal function immediately after administrated. The investigators propose a triple blind clinical trial,in which septic AKI patients will be randomized in three arms, all receive conventional treatment KDIGO guides, groupPDF 1,200 will receive PDF 600mg every 12 hrs per mouth, group PDF 600 will receive 600mg in the morning and placebo equivalent at night and Group Placebo will receive placebo every 12 hrs, all for 7 days. The Investigators analyze the recovery of renal function as a primary objective, as a secondary objectives clinical variables associated with renal recovery, biochemical variables, inflammatory, molecular variables and measurement of PDF in blood will be analyzed. Patients will be follow-up for 7 days and 28 days after randomization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n. sepsis\n\n* AKI by serum creatinine, according to the KDIGO guide 2012 Acute Kidney Injury • acute on Chronic kidney disease (baseline creatinine \\<2 mg / dL)\n\nExclusion Criteria:\n\n* Chronic kidney disease stage 3b, 4 or 5 (basal serum creatinine \\> 2mg/dl) known and / or sharpened.\n\n * chronic dialysis (peritoneal dialysis or hemodialysis)\n * History of AKI and / or RRT in the last three months\n * Pregnancy AKI by other causes other than sepsis'}, 'identificationModule': {'nctId': 'NCT02530359', 'acronym': 'AKI', 'briefTitle': 'Pirfenidone Effect on the Recovery of Renal Function in Septic Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Civil de Guadalajara'}, 'officialTitle': 'Pirfenidone Effect on the Recovery of Renal Function in Patients With Septic Acute Kidney Injury', 'orgStudyIdInfo': {'id': 'HCGFAA-DRA-PFD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'Pirfenidone extended release 600mg per mouth every 12 hours for 7 days.', 'interventionNames': ['Drug: Pirfenidone extended release']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Pirfenidone extended release 600mg per mouth in the morning and placebo by night (each treatment every 12 hrs) for 7 days.', 'interventionNames': ['Drug: Pirfenidone extended release', 'Drug: Placebo equivalent']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 3', 'description': 'Placebo equivalent per mouth every 12 hrs for 7 days.', 'interventionNames': ['Drug: Placebo equivalent']}], 'interventions': [{'name': 'Pirfenidone extended release', 'type': 'DRUG', 'description': 'Pirfenidone extended release 600mg per mouth', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Placebo equivalent', 'type': 'DRUG', 'otherNames': ['Placebo'], 'description': 'Placebo equivalent per mouth', 'armGroupLabels': ['Group 2', 'Group 3']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jonathan Chavez, Dr', 'role': 'CONTACT', 'email': 'jonarchi_10@hotmail.com', 'phone': '0443313299609'}, {'name': 'Guillermo Garcia, Dr', 'role': 'CONTACT', 'email': 'ggarcia1952@gmail.com', 'phone': '0443336622288'}], 'overallOfficials': [{'name': 'Juan Armenzadriz, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centro Universitario Ciencias de la Salud'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Civil de Guadalajara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Nephrologhist', 'investigatorFullName': 'Jonathan Samuel Chavez Iñiguez', 'investigatorAffiliation': 'Hospital Civil de Guadalajara'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-08-24', 'type': 'RELEASE'}, {'date': '2021-09-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Jonathan Samuel Chavez Iñiguez, Nephrologhist, Hospital Civil de Guadalajara'}}}}