Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-02-22 @ 5:59 AM
Study NCT ID:
NCT04267458
Status:
UNKNOWN
Last Update Posted:
2020-02-12
First Post:
2020-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Kidney Injury in Patients With HCV Treated With Sofuspovir Containing DAA Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2020-01-26', 'studyFirstSubmitQcDate': '2020-02-11', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'investigate the renal injury which can be caused during using sofuspovir containing DAA regimen in HCV treatment', 'timeFrame': 'from the start to 6 months later', 'description': 'to investigate effect of DAA on kidney of treated patients and the mechanism of the drug to cause this renal effect by causing renal buimarkers including NAG and eGFR'}], 'secondaryOutcomes': [{'measure': 'highlight the effect of DAAs on insulin resistance in diabetic patients suffering from HCV', 'timeFrame': 'from the starting of treatment till the 3-months follow up after the end of the treatment regimen', 'description': 'to estimate the effect of DAAs on HOMA-IR index f insulin resistance in diabetic infected patients and comparing their insulin resistance before and after treatment'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['DAA', 'HCV', 'egyption patients'], 'conditions': ['Investigate the Renal Effect of DAAs on Egyption Patients After Completion of Treatment']}, 'descriptionModule': {'briefSummary': 'this study aims is to investigate the occurrence of AKI during antiviral therapy, defined as an increase of 0.3 mg/dL or 50% at least in serum creatinine level when compared with baseline values or more than a 25% reduction in (eGFR) when compared with baseline eGFR in Egyptian patients.In addition to evaluate the change in insulin resistance value after treating patients from HCV.', 'detailedDescription': "There are limited published data, currently, suggesting the risk of AKI during oral direct acting antiviral treatment. Most case reports and retrospective studies reported the presence of an intrinsic cause of renal injury, with most of the available biopsies showing acute tubular necrosis (ATN) and acute interstitial nephritis (AIN). Most of these patients had returned to baseline renal function on cessation of sofosbuvir combination therapy.\n\nRecently it was found that a notable percentage of patients experienced a transient increase in creatinine during therapy, which could occasionally lead to a more than 50% decrease in patients' eGFR. Previous studies had also shown that the co-use of nonsteroidal anti-inflammatory drugs (NSAIDs) and recurrent ascites were at increased risk for AKI during sofosbuvir-based antiviral therapy.\n\nThe primary endpoint of this study is to investigate the occurrence of AKI in Egyptian patients during antiviral therapy and to highlight its reasons and time of incidence in addition to the mechanism of this injury."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients suffering from HCV\n* male or female\n* easy to treat naive patients\n\nExclusion Criteria:\n\n* pregnant women\n* seffering from HBV\n* diffecult to treat\n* other comorbodities as heart diseases or COPD'}, 'identificationModule': {'nctId': 'NCT04267458', 'briefTitle': 'Prevalence of Kidney Injury in Patients With HCV Treated With Sofuspovir Containing DAA Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'the Prevalence of Acute Kidney Injury in Patients With Chronic Hepatitis c Virus Receiving Sofuspovir Containing Direct Acting Antiviral Therapy', 'orgStudyIdInfo': {'id': '15-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'HCV infected patients with non-elevated sCr than basal levels', 'description': 'a group of egyption patients with HCV infection with non-elevated sCr than basal levels and treated with sofuspovir as an direct acting antiviral drug', 'interventionNames': ['Other: evaluation of sofuspovir containing DAA regien expected insult on kidney']}], 'interventions': [{'name': 'evaluation of sofuspovir containing DAA regien expected insult on kidney', 'type': 'OTHER', 'description': 'to use different kidney biomarkers to evaluate acute kidney damage after using sofuspovir containing DAA regimen in treatment of HCV', 'armGroupLabels': ['HCV infected patients with non-elevated sCr than basal levels']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11311', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'dalia zaafar, phd', 'role': 'CONTACT', 'email': 'dr.moda88@gmail.com'}, {'name': 'soha hassanin, phd', 'role': 'CONTACT', 'email': 'phsoha@hotmail.com'}], 'facility': 'Thabet Thabet Hospital For Internal Diseases', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Dalia Zaafar, PhD', 'role': 'CONTACT', 'email': 'dr.moda88@gmail.com', 'phone': '00201117922833'}, {'name': 'soha hassanin, PhD', 'role': 'CONTACT', 'email': 'phsoha@hotmail.com'}], 'overallOfficials': [{'name': 'Dalia Zaafar, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of pharmacology and toxicology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of pharmacology', 'investigatorFullName': 'Dalia K. Zaafar', 'investigatorAffiliation': 'Cairo University'}}}}