Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2026-01-07 @ 11:29 PM
Study NCT ID:
NCT03809533
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-06
First Post:
2019-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000611331', 'term': 'sofosbuvir-velpatasvir drug combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2019-01-15', 'studyFirstSubmitQcDate': '2019-01-15', 'lastUpdatePostDateStruct': {'date': '2025-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '5 years', 'description': 'Rate of adverse events due to sofosbuvir/velpatasvir (Epclusa) in patients in each experimental group'}, {'measure': 'HCV free at 1 year', 'timeFrame': '1 year', 'description': 'Proportion of participants in each experimental group who are free of HCV at 1 year following transplantation'}], 'secondaryOutcomes': [{'measure': 'Transmission rate of HCV from HCVAb+/NAT- donors to HCVAb- recipients', 'timeFrame': '5 years'}, {'measure': 'Incidence of allograft rejection', 'timeFrame': '5 years'}, {'measure': 'Incidence of graft loss', 'timeFrame': '5 years'}, {'measure': 'All-cause mortality', 'timeFrame': '5 years'}, {'measure': 'Waitlist time after enrollment', 'timeFrame': '5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Kidney Transplantation', 'Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This is an open-label, pilot trial to test the safety and efficacy of transplantation of kidneys from hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the kidney transplant waitlist. Treatment and prophylaxis will be administered using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).', 'detailedDescription': 'This is a prospective, single center, pilot, open-label study of transplantation of kidneys of HCVAb+ donors to HCVAb- recipients with subsequent therapy with sofosbuvir/velpatasvir (Epclusa®). Recipients of a kidney from HCVAb+/NAT- donors will be in arm 1 (the transmission-triggered arm) of the study. In this arm, the study will monitor HCV by measuring HCV RNA in renal transplant recipients. If HCV RNA is detected, indicating transmission of HCV, recipients will be treated with sofosbuvir/velpatasvir (Epclusa®) for 12 weeks. Virological response will be assessed at 4 weeks, end of treatment and 12 weeks after completion of therapy.\n\nRecipients of a kidney from HCVAb+/NAT+ donors will be in arm 2 (the prophylaxis arm) of the study. In this arm, patients will be started on a 12-week course of sofosbuvir/velpatasvir (Epclusa®) immediately post-operatively and will undergo close monitoring of HCV RNA for evidence of transmission.\n\nTo be eligible for the study, subjects need to be listed for renal transplantation, be not infected with HCV, HBV or HIV, and sign informed consent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria (recipients):\n\n1. Patients with end-stage renal disease listed for kidney transplantation at UPMC.\n2. On chronic hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease (CKD) defined as a glomerular filtration rate \\< 15 ml/min\n3. Age ≥ 18\n4. No available living kidney donor\n5. Listed for an isolated kidney transplant at UPMC with \\<60m of accrued transplant waiting time and/or \\<60m of dialysis time\n6. Have panel reactive antibody level of \\<98%\n7. No obvious contraindication to kidney transplant\n8. Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation\n9. Able to provide informed consent\n10. Be willing to use a contraceptive method for a year after transplant\n\nExclusion criteria (recipients):\n\n1. HIV positive\n2. HCVAb or HCV RNA positive\n3. Presence of behavioral risk factors for contracting HCV other than being on hemodialysis. These behavioral risk factors are current injection drug use, current intranasal illicit drug use, current percutaneous/parenteral exposures in an unregulated setting.\n4. Hepatitis B surface antigen positive\n5. History of liver cirrhosis\n6. Persistently elevated liver transaminases, defined as ALT/AST at least 3 times the upper limit of normal for a minimum of 3 consecutive months\n7. History of atrial fibrillation requiring the use of amiodarone over the past 12m\n8. Patients with etiology of renal failure with increased risk of causing early graft failure as assessed by the investigator team\n9. Receipt of prior organ transplant\n10. Waitlisted for a multi-organ transplant\n11. Pregnant women\n12. Known allergy to sofosbuvir/velpatasvir\n13. Any condition, psychiatric or physical, that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study\n\nInclusion criteria (donors):\n\n1. HCV antibody positive\n2. HCV NAT negative or positive\n3. Kidney donor profile index (KDPI) score \\<85\n\nExclusion criteria (donors):\n\n1. Confirmed HIV positive (positive HIV-1 antibody, positive HIV-2 antibody, positive p24 antigen and/or positive HIV NAT)\n2. Confirmed HBV positive (positive hepatitis B surface antigen and/or HBV NAT)\n3. Known ongoing therapy for HCV'}, 'identificationModule': {'nctId': 'NCT03809533', 'briefTitle': 'The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Transplantation of Kidneys of Hepatitis C (HCV) Seropositive Donors to HCV Seronegative Recipients With Subsequent Therapy With Sofosbuvir/Velpatasvir (Epclusa)', 'orgStudyIdInfo': {'id': 'STUDY19100135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HCV seropositive non-viremic (HCV Ab+/NAT-) donor', 'description': 'Kidney recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated.\n\nRecipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).'}, {'type': 'EXPERIMENTAL', 'label': 'HCV seropositive viremic (HCV Ab+/NAT+) donor', 'description': 'Starting post-operative day 1, kidney recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).', 'interventionNames': ['Drug: sofosbuvir/velpatasvir']}], 'interventions': [{'name': 'sofosbuvir/velpatasvir', 'type': 'DRUG', 'otherNames': ['Epclusa'], 'description': '12-week, oral, fixed-dose', 'armGroupLabels': ['HCV seropositive viremic (HCV Ab+/NAT+) donor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Amit Tevar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}, {'name': 'Fernanda Silviera, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Pittsburgh'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We do not plan to share individual patient data outside of our investigative team. Aggregate data will be shared in publications as appropriate.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amit D Tevar, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Pittsburgh Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Surgery', 'investigatorFullName': 'Amit D Tevar, MD', 'investigatorAffiliation': 'University of Pittsburgh'}}}}