Utilization of Hepatitis C Positive Kidneys in Negative Recipients
Part of paid clinical trials in Columbus, Ohio.
- Sponsor
- Ohio State University
- Study ID
- NCT03801707
- Phase
- PHASE2/PHASE3
- Status
- Completed
Conditions
- HCV
- Hepatitis C
- Kidney Transplant
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] — DRUGfixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C
- Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET] — DRUGThree tablets once a day for 12 weeks for treatment of hepatitis C
Study Details
To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection
Key Dates
- Start date
- Mar 22, 2019
- Status verified
- Aug 2023
- Primary completion
- Apr 28, 2021
- Completion
- Apr 30, 2021
Study Design
- Enrollment
- 54 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Intervention groupkidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
Primary Outcome Measure
Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment [ Time Frame: 12 weeks ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Brenda Cuson | Columbus | Ohio | 43210 | - |
Find similar trials in Columbus, OH
By research site
Related Studies
- Assessment of Biomarker-Guided CNI Substitution In Kidney TransplantationPHASE2 · Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Birmingham, Alabama
- Advancing Transplantation Outcomes in ChildrenPHASE2 · Recruiting · National Institute of Allergy and Infectious Diseases (NIAID) · Birmingham, Alabama
- Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental GlomerulosclerosisPHASE4 · Recruiting · Travere Therapeutics, Inc. · Birmingham, Alabama
- Evaluation of Patients With Liver DiseaseRecruiting · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Bethesda, Maryland