Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-03-02 @ 7:43 AM
Study NCT ID:
NCT02902120
Status:
COMPLETED
Last Update Posted:
2024-04-22
First Post:
2016-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
HCV Treatment Immune Response With Grazoprevir/Elbasvir Before or After Renal Transplant
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}}}}, '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': 'C000589335', 'term': 'elbasvir'}, {'id': 'C000611265', 'term': 'elbasvir-grazoprevir drug combination'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'LydiaTang@ihv.umaryland.edu', 'phone': '410-706-6567', 'title': 'Lydia Tang', 'organization': 'Institute of Human Virology, University of Maryland School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event information was collected throughout the subjects participation in the study, from screening through post-treatment week 12 at the following timepoints: day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28).', 'eventGroups': [{'id': 'EG000', 'title': 'Post-transplant', 'description': 'This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \\<50) who have had a kidney transplant using grazoprevir and elbasvir.\n\nPost-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 21, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated tacrolimus level', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 73, 'numAffected': 17}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated creatinine or AKI', 'notes': 'elevated Cr \\>30% baseline or a diagnosis of AKI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 21, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Low platelets', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'notes': 'Diarrhea not requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea, vomiting', 'notes': 'nausea, vomiting not requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UTI', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'candida infection', 'notes': 'oral thrush, esophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 5, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CMV viremia, syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'shingles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Leukopenia', 'notes': 'Low WBC count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased Tacrolimus levels', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 138, 'numAffected': 19}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Microalbuminuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'ankle swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated WBCs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'seasonal allergies', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pruritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dry cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'mild antibody mediated rejection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'increased glucose', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Groin strain or pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Blood Pressure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'osteoporosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'pyuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'cold sweats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URI, pharyngitis, rhinitis, bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'indigestion, GERD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'muscle cramps', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'otitis media', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Nausea, vomiting', 'notes': 'Nausea, vomiting resulting in hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'shortness of breath', 'notes': 'Shortness of breath resulting in hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'CMV Viremia', 'notes': 'CMV Viremia resulting in hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Decreased appetite', 'notes': 'Decreased appetite and intake leading to hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'UTI, sepsis', 'notes': 'UTI, sepsis with hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'notes': 'Diarrhea resulting in hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'acute kidney injury', 'notes': 'acute kidney injury resulting in hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'notes': 'Fatigue with nausea, vomiting, diarrhea and acute kidney injury leading to hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diabetic ketoacidosis', 'notes': 'DKA with shingles requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Shingles', 'notes': 'DKA with shingles requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'URI', 'notes': 'URI requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Community acquired pneumonia', 'notes': 'CAP requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'notes': 'AKI requiring hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'SVR 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-transplant', 'description': 'This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \\<50) who have had a kidney transplant using grazoprevir and elbasvir.\n\nPost-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)'}], 'classes': [{'categories': [{'title': 'Number achieved SVR12', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}, {'title': 'Number failed treatment', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Number missing SVR12 data', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This will be measured at post-treatment week 12 (study week 24 or week 28 for those with resistance mutations)', 'description': 'Sustained virologic response (SVR) will be assessed by measuring the quantitative HCV viral load 12 weeks after completing treatment. This will be a measure of circulating HCV virus in participants off therapy, 12 weeks after finishing treatment, to determine the durability of the response to the treatment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in T Cell Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-transplant', 'description': 'This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \\<50) who have had a kidney transplant using grazoprevir and elbasvir.\n\nPost-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)'}], 'classes': [{'title': 'PD-1 day 0', 'categories': [{'measurements': [{'value': '29.15', 'spread': '15.21', 'groupId': 'OG000'}]}]}, {'title': 'PD-1 week 4', 'categories': [{'measurements': [{'value': '21.83', 'spread': '14.52', 'groupId': 'OG000'}]}]}, {'title': 'PD-1 week 12', 'categories': [{'measurements': [{'value': '20.5', 'spread': '8.91', 'groupId': 'OG000'}]}]}, {'title': 'ICOS day 0', 'categories': [{'measurements': [{'value': '12.73', 'spread': '7.92', 'groupId': 'OG000'}]}]}, {'title': 'ICOS week 4', 'categories': [{'measurements': [{'value': '6.14', 'spread': '5.65', 'groupId': 'OG000'}]}]}, {'title': 'ICOS week 12', 'categories': [{'measurements': [{'value': '5.03', 'spread': '2.81', 'groupId': 'OG000'}]}]}, {'title': 'CD38 day 0', 'categories': [{'measurements': [{'value': '10.86', 'spread': '4.81', 'groupId': 'OG000'}]}]}, {'title': 'CD38 week 4', 'categories': [{'measurements': [{'value': '5.97', 'spread': '4.43', 'groupId': 'OG000'}]}]}, {'title': 'CD38 week 12', 'categories': [{'measurements': [{'value': '6.73', 'spread': '4.48', 'groupId': 'OG000'}]}]}, {'title': 'CD69 day 0', 'categories': [{'measurements': [{'value': '0.98', 'spread': '0.60', 'groupId': 'OG000'}]}]}, {'title': 'CD69 week 4', 'categories': [{'measurements': [{'value': '0.43', 'spread': '0.26', 'groupId': 'OG000'}]}]}, {'title': 'CD69 week 12', 'categories': [{'measurements': [{'value': '0.75', 'spread': '0.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This will be collected at day 0, week 4, and week 12', 'description': 'The study will involve measuring the change in T cell response by analyzing the frequency of exhaustion markers PD-1 and activation markers ICOS, CD38, CD69 at day 0, week 4, and week 12.', 'unitOfMeasure': 'percentage of expressing cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was amended to eliminate the comparator arm and focus on clinical outcomes including SVR12. No subjects were recruited in this arm, so no data was collected or is available.'}, {'type': 'SECONDARY', 'title': 'Change in T Cell Immunophenotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-transplant', 'description': 'This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \\<50) who have had a kidney transplant using grazoprevir and elbasvir.\n\nPost-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)'}], 'classes': [{'title': 'CD4+CCR7-CD45RO+ EM day 0', 'categories': [{'measurements': [{'value': '70.64', 'spread': '17.48', 'groupId': 'OG000'}]}]}, {'title': 'CD4+CCR7-CD45RO+ EM week 4', 'categories': [{'measurements': [{'value': '65.4', 'spread': '11.17', 'groupId': 'OG000'}]}]}, {'title': 'CD4+CCR7-CD45RO+ EM week 12', 'categories': [{'measurements': [{'value': '65.1', 'spread': '13.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This will be collected at day 0, week 4, and week 12', 'description': 'The study will involve measuring the change in T cell immunophenotypes', 'unitOfMeasure': 'percentage of expressing cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was amended to eliminate the comparator arm and focus on clinical outcomes including SVR12. No subjects were recruited in this arm, so no data was collected or is available.\n\nThe frequency of CD4+ and CD8+ effector memory, naïve, central memory and terminally differentiated effector memory cell populations were compared from day 0 to week 4 on treatment.'}, {'type': 'SECONDARY', 'title': 'Quantification of Antiviral Cytokines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-transplant', 'description': 'This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \\<50) who have had a kidney transplant using grazoprevir and elbasvir.\n\nPost-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)'}], 'classes': [{'title': 'IFN gamma day 0', 'categories': [{'measurements': [{'value': '9.67', 'spread': '7.12', 'groupId': 'OG000'}]}]}, {'title': 'IFN gamma week 4', 'categories': [{'measurements': [{'value': '7.26', 'spread': '6.19', 'groupId': 'OG000'}]}]}, {'title': 'TNF alpha day 0', 'categories': [{'measurements': [{'value': '7.26', 'spread': '2.74', 'groupId': 'OG000'}]}]}, {'title': 'TNF alpha week 4', 'categories': [{'measurements': [{'value': '4.45', 'spread': '3.55', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'This will be collected at day 0 and week 4', 'description': 'The study will involve measuring interferon gamma and TNF alpha levels', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was amended to eliminate the comparator arm and focus on clinical outcomes including SVR12. No subjects were recruited in this arm, so no data was collected or is available.\n\nAnalysis was done comparing IFN gamma and TNF alpha from day 0 to week 4.'}, {'type': 'SECONDARY', 'title': 'Safety as Assessed by Adverse Event Monitoring, Including Routine Lab Work', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-transplant', 'description': 'This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \\<50) who have had a kidney transplant using grazoprevir and elbasvir.\n\nPost-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)'}], 'classes': [{'title': 'Any Adverse Event', 'categories': [{'title': 'Yes', 'measurements': [{'value': '21', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Any Serious Adverse Event', 'categories': [{'title': 'Yes', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': 'Decrease in eGFR >30% from baseline', 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}, {'title': 'Elevated tacrolimus level while on treatment', 'categories': [{'title': 'Yes', 'measurements': [{'value': '13', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This will be measured at day 0, weeks 2, 4, 8, 12 (and 16 if resistance mutations are present)', 'description': 'Safety will be assessed by adverse event monitoring, including routine lab work', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Kidney Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-transplant', 'description': 'This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \\<50) who have had a kidney transplant using grazoprevir and elbasvir.\n\nPost-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)'}], 'classes': [{'title': 'Increase in Cr >30% on treatment', 'categories': [{'title': 'yes', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'no', 'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Decrease eGFR >30%', 'categories': [{'title': 'yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'no', 'measurements': [{'value': '17', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This will be measured at day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28)', 'description': "Clinical review using labs and the patient's chart will be performed for change in kidney graft function by change in eGFR or creatinine", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Kidney Allograft Rejection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Post-transplant', 'description': 'This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \\<50) who have had a kidney transplant using grazoprevir and elbasvir.\n\nPost-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)'}], 'classes': [{'categories': [{'title': 'Borderline acute cellular rejection', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Mild antibody mediated rejection', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No rejection', 'measurements': [{'value': '19', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'This will be measured at post-treatment week 12', 'description': "Clinical review using labs and the patient's chart will be performed for documented episodes of kidney rejection", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Post-transplant', 'description': 'This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \\<50) who have had a kidney transplant using grazoprevir and elbasvir.\n\nPost-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Post-transplant', 'description': 'This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \\<50) who have had a kidney transplant using grazoprevir and elbasvir.\n\nPost-transplant Grazoprevir and Elbasvir: Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.65', 'spread': '8.17', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '16', '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': '19', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', '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': '19', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '2', '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': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Fibrosis Stage', 'classes': [{'categories': [{'title': 'Fibrosis Stage 0-1', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Fibrosis Stage 2-3', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Fibrosis staging was done within 12 months prior to enrollment by liver biopsy, transient elastography using Fibroscan or biochemical testing using FibroTest. These tests produced results corresponding to a fibrosis stage with a fibrosis stage 0-1 being less severe and 2-3 being more severe fibrosis. Fibrosis stage 4, being the most severe/cirrhosis, was excluded from the study.\n\nSix participants had disease staging done by liver biopsy, 6 participants by transient elastography using Fibroscan, and 9 participants by biochemical testing by FibroTest.', 'unitOfMeasure': 'Participants'}, {'title': 'HCV-positive donor', 'classes': [{'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'HCV genotype post-transplant', 'classes': [{'categories': [{'title': 'Genotype 1a', 'measurements': [{'value': '14', 'groupId': 'BG000'}]}, {'title': 'Genotype 1b', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'HCV genotype as measured by a serum HCV genotype test, prior to HCV treatment. Genotype 1 was required for inclusion based upon the treatment recommendations for elbasvir/grazoprevir in genotype 1 at the time. Data was further used to detect genotype 1a which required additional testing to ensure no NS5a resistance associated variants (RAVs) were present which may impact the duration of treatment.', 'unitOfMeasure': 'Participants'}, {'title': 'Median baseline HCV RNA level', 'classes': [{'categories': [{'measurements': [{'value': '6.24', 'groupId': 'BG000', 'lowerLimit': '5.56', 'upperLimit': '6.65'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'Log international units/mL', 'dispersionType': 'FULL_RANGE'}, {'title': 'Time from transplant', 'classes': [{'categories': [{'measurements': [{'value': '117', 'groupId': 'BG000', 'lowerLimit': '44', 'upperLimit': '321'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'days', 'dispersionType': 'FULL_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-08', 'size': 917510, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-23T16:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-06-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2016-08-19', 'resultsFirstSubmitDate': '2022-06-23', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2024-04-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-26', 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SVR 12', 'timeFrame': 'This will be measured at post-treatment week 12 (study week 24 or week 28 for those with resistance mutations)', 'description': 'Sustained virologic response (SVR) will be assessed by measuring the quantitative HCV viral load 12 weeks after completing treatment. This will be a measure of circulating HCV virus in participants off therapy, 12 weeks after finishing treatment, to determine the durability of the response to the treatment.'}], 'secondaryOutcomes': [{'measure': 'Change in T Cell Response', 'timeFrame': 'This will be collected at day 0, week 4, and week 12', 'description': 'The study will involve measuring the change in T cell response by analyzing the frequency of exhaustion markers PD-1 and activation markers ICOS, CD38, CD69 at day 0, week 4, and week 12.'}, {'measure': 'Change in T Cell Immunophenotypes', 'timeFrame': 'This will be collected at day 0, week 4, and week 12', 'description': 'The study will involve measuring the change in T cell immunophenotypes'}, {'measure': 'Quantification of Antiviral Cytokines', 'timeFrame': 'This will be collected at day 0 and week 4', 'description': 'The study will involve measuring interferon gamma and TNF alpha levels'}, {'measure': 'Safety as Assessed by Adverse Event Monitoring, Including Routine Lab Work', 'timeFrame': 'This will be measured at day 0, weeks 2, 4, 8, 12 (and 16 if resistance mutations are present)', 'description': 'Safety will be assessed by adverse event monitoring, including routine lab work'}, {'measure': 'Kidney Function', 'timeFrame': 'This will be measured at day 0, treatment week 2, treatment week 4, treatment week 8, treatment week 12, ( treatment week 16, if applicable), post-treatment week 4 (week 16/20), and post-treatment week 12 (week 24/28)', 'description': "Clinical review using labs and the patient's chart will be performed for change in kidney graft function by change in eGFR or creatinine"}, {'measure': 'Kidney Allograft Rejection', 'timeFrame': 'This will be measured at post-treatment week 12', 'description': "Clinical review using labs and the patient's chart will be performed for documented episodes of kidney rejection"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C', 'Renal Insufficiency, Chronic', 'Disorder of Transplanted Kidney']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether patients treated for chronic hepatitis C (HCV) with zepatier (grazoprevir/elbasvir) prior to kidney transplant will have a stronger immune response compared to patients treated after kidney transplant. 25 patients with chronic kidney disease (CKD) and HCV will be treated with zepatier and 25 kidney transplant recipients with chronic kidney disease will be treated with zepatier. Blood markers of immune function will be monitored in both groups to determine their response to therapy.', 'detailedDescription': "The study will be a pilot, prospective, single-center, open-label, non-randomized, non-controlled, parallel clinical trial. 25 HCV genotype 1 infected patients post transplant will be enrolled in the study. Recruitment will be conducted through the renal transplant and nephrology outpatient clinics at the University of Maryland.\n\nThe post-transplant cohort will include renal transplant recipients of both living donor and deceased donor organs infected with HCV prior to their transplantation with GFRs \\<50 with active HCV viremia. These patients will be recruited from the University of Maryland's multidisciplinary transplant nephrology clinic or infectious disease clinic.\n\nScreening All patients will be screened at the Institute of Human Virology (IHV) Clinical Research Unit. At this visit, all patients will have screening labs drawn and a history and physical examination performed. Additional requirements will be genotype testing prior to enrollment, but after transplant and disease staging within 12 months of enrollment by liver biopsy, elastography, or biochemical testing. For those who do not have a genotype or disease staging within the specified time frame, genotyping and elastography will be repeated as part of the study screening work up. Eligibility will be determined based upon these results within 6 weeks of starting the study drugs.\n\nGiven the reduced efficacy of this regimen in patients with genotype 1a with the presence of baseline NS5A resistance-associated variants (RAVs), the investigators will screen patients for RAVs in patients with HCV genotype 1a at the time of enrollment. Any patient with genotype 1a HCV found to have NS5A RAVs will undergo 16 weeks of therapy according to current treatment guidelines.\n\nStarting therapy Study drugs will be administered starting on day 0 after a history and physical examination is performed and safety labs are checked. All patients will sign an informed consent as approved by our Institutional Review Board (IRB) prior to administration of study drugs.\n\nStudy visits during treatment Patients will be followed every 4 weeks while they are receiving study drugs. HCV viral load (VL), safety labs and hepatic panel will be performed at each of these visits. Patients will also be advised about study adherence and monitored for adverse events.\n\nSafety and adverse event monitoring At each study visit, research nurses will inquire about adverse events that may or may not be related to study drugs. Any unfavorable medical occurrences will be recorded, whether or not considered related to the patient's participation in the research, temporally associated with the patient's participation in the research. Adverse events (AEs) classified as grade 3 or higher will be reported to the IRB and principal investigator. Any grade 3 or 4 AEs and all serious adverse events (SAEs) will be reviewed as they occur by the study team.\n\nSafety labs will also be drawn at these visits. Levels of immunosuppressive agents will also be determined at these visits as appropriate. The need for dose modification of the patient's immunosuppression in the time between visits will be recorded.\n\nEnd of treatment visit Patients will be seen 12 weeks after starting study drugs (or 16 weeks in the case of genotype 1a patients with baseline NS5A RAVs) for an end of study visit. HCV VL, safety labs and hepatic panel will be performed at this visit. Patients will also be counseled about study adherence and the investigators will inquire about adverse events.\n\nPost treatment follow up visits Patients will be followed every 4 weeks for 12 weeks after they complete treatment. HCV VL, safety labs and a hepatic panel will be performed at these visits."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* At least 18 years of age at the time of screening\n* Have stable renal function for one month (30 days) prior to enrollment\n* Have Chronic HCV infection prior to transplantation with documented HCV viremia ≥ 1,000 IU/ml at screening and either documented HCV Ab positivity or HCV viremia ≥ 1,000 IU/ml at least 6 months prior to enrollment.\n* Documented genotype 1 HCV infection prior to enrollment and after their transplant in the post-transplantation cohort\n* HCV disease staging within 12 months prior to enrollment by liver biopsy, transient elastography, or biochemical testing\n* Be able to give informed consent and comply with study guidelines\n* Women of childbearing age will be required to have a negative pregnancy test at enrollment and use birth control throughout the duration of treatment.\n\nInclusion Criteria Specific to the Pre-transplant Arm\n\nPatients will either be:\n\n* On the transplant waiting list followed by the University of Maryland's nephrology clinic or the Baltimore VA's nephrology clinic\n* On chronic hemodialysis not yet on the transplant list and followed in the University's hemodialysis center or in the University's nephrology clinic\n* Have chronic kidney disease with GFR \\<50\n\nInclusion Criteria Specific to the Post-transplant Arm\n\n• Patients will have undergone renal transplantation no greater than five years prior to enrollment and will be followed in our University's nephrology and infectious disease clinic. They will all have stable renal function at the time of enrollment.\n\nExclusion Criteria:\n\n* Documented positive hepatitis B (HBV) surface antigen, and/or HBV DNA prior to enrollment\n* Any prior exposure to HCV protease inhibitor therapy\n* HIV co-infection if on a protease inhibitor based regimen\n* Increase in creatinine of 15% or greater within one month (30 days) of the screening visit\n* Evidence of hepatocellular carcinoma at the time of enrollment\n* Liver disease caused by an etiology other than HCV\n* F4 or decompensated cirrhotic patients\n* Child Pugh class B or C\n* AST or ALT \\>350 within 6 months prior to enrollment\n* Albumin \\< 3g/dL at the time of enrollment\n* Platelet count \\< 75 at the time of enrollment\n* History of clinically significant allergy or adverse event with protease inhibitors\n* Evidence of the acquisition of HCV at the time of or after transplantation\n* Pregnant or breastfeeding women\n* Cyclosporine; St. John's Wort; Efavirenz; Phenytoin; Carbamazepine; Bosentan; HIV protease inhibitors; modafinil; ketoconazole; or rifampin use within 7 days of enrollment\n* Coadministration of more than 20 mg atorvastatin; 10 mg rosuvastatin; 20 mg of fluvastatin, lovastatin or simvastatin"}, 'identificationModule': {'nctId': 'NCT02902120', 'briefTitle': 'HCV Treatment Immune Response With Grazoprevir/Elbasvir Before or After Renal Transplant', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Host Mechanisms Involved in Achieving SVR Using Grazoprevir and Elbasvir in Treatment of Chronic Hepatitis C in Patients With CKD Before and After Renal Transplantation', 'orgStudyIdInfo': {'id': 'HP-00071069'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Post-transplant', 'description': 'This arm will evaluate the treatment of patients with HCV and chronic kidney disease (GFR \\<50) who have had a kidney transplant using grazoprevir and elbasvir.', 'interventionNames': ['Drug: Post-transplant Grazoprevir and Elbasvir']}], 'interventions': [{'name': 'Post-transplant Grazoprevir and Elbasvir', 'type': 'DRUG', 'otherNames': ['Zepatier'], 'description': 'Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)', 'armGroupLabels': ['Post-transplant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Jennifer S Husson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland School of Medicine, Institute of Human Virology'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available immediately upon publication for a duration of 5 years following publication.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported, after deidentification will be shared.', 'accessCriteria': 'Investigators who provide a methodologically sound proposal to achieve the aims in the approved proposal.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jennifer Husson', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}