Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-04-03 @ 7:26 PM
Study NCT ID:
NCT02503735
Status:
TERMINATED
Last Update Posted:
2020-01-13
First Post:
2015-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Harvoni on Proteinuria and eGFR in Hepatitis C Virus Associated Chronic Kidney Disease (CKD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'C000595958', 'term': 'ledipasvir, sofosbuvir drug combination'}], 'ancestors': [{'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'MSise@partners.org', 'phone': '617-726-5050', 'title': 'Dr. Meghan Sise', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Data was collected over 52 week study period (which includes 12 weeks of treatment with Harvoni, and 40 weeks of post-treatment follow-up).', 'eventGroups': [{'id': 'EG000', 'title': '12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)', 'description': 'Sofosbuvir/Ledipasvir FDC: 12 weeks treatment with Harvoni (10 total dosed on protocol)\n\nPatients were followed for one year following treatment initiation', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 7, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'reduced appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'acid reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'back/joint pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated blood prsesure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'mouth pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'forgetfulness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'frequent urination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'elevated creatinine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fall / twisted ankle', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'intestinal blockage', 'notes': 'This severe adverse event (SAE) required hospitalization occurred 4 weeks after completing LDV/SOF. The intestinal condition was pre-existing and the SAE was deemed unrelated to study participation by the principal investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Percent Change in Proteinuria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)', 'description': 'Participants received sofosbuvir/Ledipasvir FDC for 12 weeks treatment (10 total dosed on protocol)\n\nProteinuria is assessed at baseline (initiation of treatment) and at 24 weeks after baseline (12 weeks after completion of treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '-14', 'groupId': 'OG000', 'lowerLimit': '-42', 'upperLimit': '52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline and 24 weeks (12 weeks after completion of Harvoni)', 'description': '% change in proteinuria from baseline (timepoint week 0) through timepoint week 24, which was 12 weeks after completion of Harvoni.', 'unitOfMeasure': 'percentage change from baseline', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Median Change in eGFR From Baseline to Timepoint Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)', 'description': 'Participants received sofosbuvir/Ledipasvir FDC for 12 weeks treatment (10 total dosed on protocol)\n\nWe determined the median change in eGFR as measured by creatinine and cystatin C equation from baseline to timepoint week 24 (12 weeks after completion of treatment)'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '2.75'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 weeks', 'description': 'Median change from baseline (timepoint week 0) to timepoint week 24, which was 12 weeks after completion of Harvoni.\n\nMedian change in eGFR was calculated using the creatinine and cystatin C-based estimating equation.\n\neGFR = 135 × min(SCr/κ, 1)α × max(SCr/κ, 1)-0.601 × min(Scys/0.8, 1)-0.375 × max(Scys/0.8, 1)-0.711 × 0.995Age × 0.969 \\[if female\\] × 1.08 \\[if black\\]', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With ≥25% Reduction in Proteinuria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)', 'description': 'Participants received Sofosbuvir/Ledipasvir FDC for 12 weeks treatment (10 total dosed on protocol)\n\nWe want to determine the number of participants with at least a 25% Reduction in Proteinuria'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 weeks', 'description': 'Number of participants with at least -25% change in proteinuria, calculated from baseline (timepoint week 0) to timepoint week 24, which is 12 weeks after completion of Harvoni.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Time in Weeks to Maximum Reduction in Proteinuria', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)', 'description': 'Participants received sofosbuvir/Ledipasvir FDC for 12 weeks treatment (10 total dosed on protocol)\n\nThe time to maximum reduction in proteinuria was assessed for each participant and compiled, and a mean is presented'}], 'classes': [{'categories': [{'measurements': [{'value': '39.4', 'spread': '12.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '52 weeks', 'description': 'This outcome evaluated all post-baseline proteinuria values through the 52 week followup, and determined which demonstrated the greatest negative change (reduction) from baseline. We then calculate the mean time to maximum reduction of proteinuria.', 'unitOfMeasure': 'weeks', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Because 3 patients had rising proteinuria they are not included in this analysis, which only looks at the mean time to reduction in proteinuria in the 7 patients who had any reductions in proteinuria. This includes the 3 patients who had -25% change in proteinuria and 4 patients who had smaller negative changes (reductions) in proteinuria.'}, {'type': 'SECONDARY', 'title': 'Median Change in eGFR From Baseline to Timepoint Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)', 'description': 'Participants HCV and proteinuria received 12 weeks treatment with Sofosbuvir/Ledipasvir (400mg/90mg)\n\nThe median change in eGFR from baseline to timepoint week 52 was determined, as measured by the creatinine and cystatin C-based estimating equation'}], 'classes': [{'categories': [{'measurements': [{'value': '-4', 'groupId': 'OG000', 'lowerLimit': '-11.25', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '52 weeks', 'description': 'Median change from baseline (timepoint week 0) to timepoint week 52, which was 40 weeks after completion of Harvoni.\n\nMedian change in eGFR was calculated using the creatinine and cystatin C-based estimating equation.\n\neGFR = 135 × min(SCr/κ, 1)α × max(SCr/κ, 1)-0.601 × min(Scys/0.8, 1)-0.375 × max(Scys/0.8, 1)-0.711 × 0.995Age × 0.969 \\[if female\\] × 1.08 \\[if black\\]', 'unitOfMeasure': 'mL/min/1.73m^2', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Sofosbuvir/Ledipasvir FDC: 12 weeks treatment with Harvoni (10 total dosed on protocol)'}, {'type': 'SECONDARY', 'title': 'Change in Urinary β-2microglobulin Levels Before Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)', 'description': '12 weeks treatment with Sofosbuvir/Ledipasvir (400mg/90mg) for patients with HCV and HCV-associated CKD'}], 'timeFrame': '24 weeks', 'description': 'Change in urinary β-2microglobulin levels before therapy with ledipasvir/sofosbuvir fixed dose combination pill.\n\nβ-2microglobulin (mcg/L) change prior to initiating HCV-treatment.\n\nThis outcome was not assessed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Data were not collected and the outcome cannot be reported. Values for urinary β-2microglobulin were obtained at baseline and not at screening. Thus we are unable to report a "change in urinary β-2microglobulin levels BEFORE therapy with ledipasvir/sofosbuvir" - however, we are able to report the changes after therapy as followup values were done.'}, {'type': 'SECONDARY', 'title': 'Change in Urinary β-2microglobulin Levels After Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)', 'description': 'Participants with HCV and proteinuria received 12 weeks treatment with Sofosbuvir/Ledipasvir (400mg/90mg)\n\nChange in urinary β-2microglobulin levels after therapy with ledipasvir/sofosbuvir fixed dose combination pill\n\nβ-2microglobulin (mcg/L) levels were measured at baseline and at timepoint week 24'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000', 'lowerLimit': '-14', 'upperLimit': '546'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '24 weeks', 'description': 'Change in urinary β-2microglobulin levels after therapy with ledipasvir/sofosbuvir fixed dose combination pill\n\nβ-2microglobulin (mcg/L) levels were assessed at baseline (timepoint week 0) and at timepoint week 24. Change was recorded for each patient, and presented as a median with IQR.', 'unitOfMeasure': 'mcg/L', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)', 'description': 'Sofosbuvir/Ledipasvir FDC: 12 weeks treatment with Harvoni (10 total dosed on protocol)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': '10/14 consented patients started treatment with Sofosbuvir/Ledipasvir (4 screen failures)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'SVR 12 (12week Post Treatment RNA Neg)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'comment': 'All 10 subjects who initiated treatment completed treatment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '14 patients were recruited and signed informed consent'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '12 Weeks Treatment With Sofosbuvir/Ledipasvir (400mg/90mg)', 'description': 'Sofosbuvir/Ledipasvir (400mg/90mg) FDC: 12 weeks treatment with Harvoni for patients with Hepatitis C (HCV) and HCV-associated CKD\n\nSubjects were followed for one year after treatment initiation'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HCV genotype', 'classes': [{'categories': [{'title': '1a', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '1b', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '4', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'mixed', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'CKD stage', 'classes': [{'categories': [{'title': '1', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': '2', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '3', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline HCV RNA', 'classes': [{'categories': [{'measurements': [{'value': '1,573,500', 'groupId': 'BG000', 'lowerLimit': '564,250', 'upperLimit': '4,162,500'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'IU/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Prior PEG-IFN/ribavirin treatment', 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes mellitus', 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Coronary artery disease', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Congestive heart failure', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2017-03-30', 'size': 538608, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-12-12T10:25', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Unable to meet enrollment goal', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-08', 'studyFirstSubmitDate': '2015-07-17', 'resultsFirstSubmitDate': '2019-11-21', 'studyFirstSubmitQcDate': '2015-07-20', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-06', 'studyFirstPostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Percent Change in Proteinuria', 'timeFrame': 'Baseline and 24 weeks (12 weeks after completion of Harvoni)', 'description': '% change in proteinuria from baseline (timepoint week 0) through timepoint week 24, which was 12 weeks after completion of Harvoni.'}], 'secondaryOutcomes': [{'measure': 'Median Change in eGFR From Baseline to Timepoint Week 24', 'timeFrame': '24 weeks', 'description': 'Median change from baseline (timepoint week 0) to timepoint week 24, which was 12 weeks after completion of Harvoni.\n\nMedian change in eGFR was calculated using the creatinine and cystatin C-based estimating equation.\n\neGFR = 135 × min(SCr/κ, 1)α × max(SCr/κ, 1)-0.601 × min(Scys/0.8, 1)-0.375 × max(Scys/0.8, 1)-0.711 × 0.995Age × 0.969 \\[if female\\] × 1.08 \\[if black\\]'}, {'measure': 'Number of Participants With ≥25% Reduction in Proteinuria', 'timeFrame': '24 weeks', 'description': 'Number of participants with at least -25% change in proteinuria, calculated from baseline (timepoint week 0) to timepoint week 24, which is 12 weeks after completion of Harvoni.'}, {'measure': 'Mean Time in Weeks to Maximum Reduction in Proteinuria', 'timeFrame': '52 weeks', 'description': 'This outcome evaluated all post-baseline proteinuria values through the 52 week followup, and determined which demonstrated the greatest negative change (reduction) from baseline. We then calculate the mean time to maximum reduction of proteinuria.'}, {'measure': 'Median Change in eGFR From Baseline to Timepoint Week 52', 'timeFrame': '52 weeks', 'description': 'Median change from baseline (timepoint week 0) to timepoint week 52, which was 40 weeks after completion of Harvoni.\n\nMedian change in eGFR was calculated using the creatinine and cystatin C-based estimating equation.\n\neGFR = 135 × min(SCr/κ, 1)α × max(SCr/κ, 1)-0.601 × min(Scys/0.8, 1)-0.375 × max(Scys/0.8, 1)-0.711 × 0.995Age × 0.969 \\[if female\\] × 1.08 \\[if black\\]'}, {'measure': 'Change in Urinary β-2microglobulin Levels Before Therapy', 'timeFrame': '24 weeks', 'description': 'Change in urinary β-2microglobulin levels before therapy with ledipasvir/sofosbuvir fixed dose combination pill.\n\nβ-2microglobulin (mcg/L) change prior to initiating HCV-treatment.\n\nThis outcome was not assessed.'}, {'measure': 'Change in Urinary β-2microglobulin Levels After Therapy', 'timeFrame': '24 weeks', 'description': 'Change in urinary β-2microglobulin levels after therapy with ledipasvir/sofosbuvir fixed dose combination pill\n\nβ-2microglobulin (mcg/L) levels were assessed at baseline (timepoint week 0) and at timepoint week 24. Change was recorded for each patient, and presented as a median with IQR.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['CKD', 'HCV'], 'conditions': ['Hepatitis C', 'Chronic Kidney Disease']}, 'referencesModule': {'references': [{'pmid': '18295055', 'type': 'BACKGROUND', 'citation': 'Stevens LA, Coresh J, Schmid CH, Feldman HI, Froissart M, Kusek J, Rossert J, Van Lente F, Bruce RD 3rd, Zhang YL, Greene T, Levey AS. Estimating GFR using serum cystatin C alone and in combination with serum creatinine: a pooled analysis of 3,418 individuals with CKD. Am J Kidney Dis. 2008 Mar;51(3):395-406. doi: 10.1053/j.ajkd.2007.11.018.'}]}, 'descriptionModule': {'briefSummary': 'Treatment protocol to see if people with hepatitis C (HCV) and chronic kidney disease (CKD) who are treated with Harvoni for 12 weeks have improvements in their kidney disease.', 'detailedDescription': 'The investigators hypothesize that patients with early stage (1-3) CKD caused by HCV infection will have significantly improved proteinuria and eGFR after viral eradication with 12 weeks of treatment Harvoni (LDV/SOF). This trial data will serve as the basis to support further study of LDV/SOF in patients with early CKD. Slowing progression of CKD is a critical goal, as the increasing incidence and prevalence of advanced CKD and end stage renal disease (ESRD) places significant health burden on patients and tremendous costs on our health-care system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subject has signed the written informed consent\n* Male or female ≥ 18 year of age\n* HCV genotype 1 or 4 with ribonucleic acid (HCV RNA) greater than 1000 international units (IU)/milliliter (mL), determined by HCV RNA polymerase chain reaction Roche TaqMan quantitative assay.\n* Initial diagnosis of proteinuric chronic kidney disease occurred \\< 7 years prior to completion of screening\n* Women of childbearing potential (i.e. women who have not undergone hysterectomy or bilateral oophorectomy, or no medically documented ovarian failure, and are ≤ 50 years of age) must agree to 1 medically approved contraceptive measures and have their partners agree to an additional barrier method of contraception for the duration of the study and for 4 weeks after the last administration of the study drug. Women of childbearing potential must not rely on hormone-containing contraceptive as a form of birth control during the study but may use. An intrauterine device, female barrier methods with cervical cap or diaphragm with spermicidal agent, tubal sterilization, or vasectomy in male partners.\n* Male subjects must agree to consistently and correctly use a condom during heterosexual intercourse and avoid sperm donation for the duration of this study and for 90 days after the last dose of ledipasvir and sofosbuvir. Additionally, if their female partner is of childbearing potential (as defined above), their partner must agree to use either 1 of the non-hormonal methods of birth control listed above or a hormone-containing contraceptive for 90 days after last study drug date. Hormone-containing contraceptive options for partners include implants of levonorgestrel, injectable progesterone, oral contraceptives, contraceptive vaginal ring, or transdermal contraceptive pat\n* Adequate organ function defined as follows platelets ≥ 50 x 109/L; hemoglobin ≥ 9 g/dL, estimated glomerular filtration rate ≥ 30mL/min/1.73m2 as estimated by CKD-Epi equation.\n* Liver imaging to exclude hepatocellular carcinoma (HCC) is required within 6 months in any patient with cirrhosis.\n* Has \\> 300mg/g creatinine proteinuria on two urine samples obtained within 30 days of starting ledipasvir and sofosbuvir.\n\nExclusion Criteria:\n\n* History of evidence of clinically significant disorder other than hepatitis C virus infection or clinically significant laboratory finding that in the investigator's judgment would pose a risk to subject safety, interfere with study procedures, or prevent completion of the study.\n* Pregnant or lactating female\n* Uncontrolled depression or psychiatric disease interfering with the ability to comply with the study procedures or complete the study\n* History or presence of any form of cancer within 3 years prior to enrollment, with the exception of excised basal cell or squamous cell carcinoma of the skin, stage 0 or 1 melanoma, or cervical carcinoma in site or breast carcinoma in situ that has been excised or resected completely and is without evidence of local recurrence or metastasis.\n* Experience life-threatening cryoglobulinemic vasculitis requiring initiation of rituximab, steroids or plasmapheresis.\n* Concomitant use of cimetidine, trimethoprim or other drugs which can increase tubular creatinine reabsorption\n* Uncontrolled cardiovascular or pulmonary disease\n* Uncontrolled hypertension\n* Known HIV infection\n* Known hypersensitivity to ledipasvir or sofosbuvir\n* Prior HCV treatment failure using a medication in the NS5A inhibitor class\n* Individuals who are taking the following medications and require continuation of the medications during the proposed study period will be excluded, given known interactions with ledipasvir-sofosbuvir: Carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifampin, isoniazid, rifapentine, rosuvastatin, proton pump inhibitors, digoxin, modafinil, and St. John's wort, milk thistle, Echinacea.\n* Having an alternate explanation of chronic kidney disease, including:\n\n * Diabetic kidney disease, either by biopsy findings or duration of uncontrolled diabetes \\> 8 years without serologic evidence of immune-complex related kidney disease\n * Chronic hypertensive nephropathy without proteinuria\n * Lupus nephritis\n * Multiple myeloma\n * Obesity related proteinuria, BMI \\> 35\n * Ongoing nephrotoxic medication use, including NSAIDS\n * Polycystic kidney disease\n * Kidney biopsy showing an alternate explanation for chronic kidney disease"}, 'identificationModule': {'nctId': 'NCT02503735', 'briefTitle': 'Effect of Harvoni on Proteinuria and eGFR in Hepatitis C Virus Associated Chronic Kidney Disease (CKD)', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Effect of Ledipasvir and Sofosbuvir on Proteinuria and Estimated Glomerular Filtration Rate in Patients With Early Stage (1-3) Hepatitis C Associated Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'IN-US-337-1777'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '12 weeks treatment with Sofosbuvir/Ledipasvir (400mg/90mg)', 'description': '10 patients with hepatitis C (HCV) and HCV-associated CKD that will receive 12 weeks treatment with Sofosbuvir/Ledipasvir (400mg/90mg)', 'interventionNames': ['Drug: Sofosbuvir/Ledipasvir FDC']}], 'interventions': [{'name': 'Sofosbuvir/Ledipasvir FDC', 'type': 'DRUG', 'otherNames': ['Harvoni'], 'description': '12 weeks treatment with Harvoni', 'armGroupLabels': ['12 weeks treatment with Sofosbuvir/Ledipasvir (400mg/90mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Elizabeth Hohmann, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Chair and Physician Director, Partners Human Research Committees'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Hepatology', 'investigatorFullName': 'Raymond Chung', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}