At a glance
ClinicalIndex Comparison Record- ✓Waitlisted for isolated kidney transplant (dialysis not required)
- ✓Age 30-70 years at enrollment
- ✓Panel reactive antibody level ≤97%
- ✓eGFR <15 mL/min/1.73m2 on MDRD equation
- ✕HIV positive
- ✕HCV RNA positive (isolated HCV antibody positive allowed if no prior treatment history)
- ✕Hepatitis B surface antigen positive
- ✕Hepatocellular carcinoma
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Labeled Trial Of Direct-Acting Antiviral Treatment Of Hepatitis C-Negative Patients Who Receive Kidney Transplants From Hepatitis C-Positive Donors
In Brief
A Phase 2 clinical trial evaluating Zepatier and Mavyret for End Stage Renal Disease. Completed, enrolled 62 participants across 1 site.
Detailed Summary
This study is being conducted to determine safety and effectiveness of transplanting kidneys from Hepatitis C-positive donors into Hepatitis C-negative patients on the kidney transplant waitlist, who will then be treated with the appropriate direct-acting antiviral (DAA) after the single kidney transplantation.
Study Details
Timeline
Interventions
Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
Mavyret (glecaprevir 100 mg and pibrentasvir 40 mg) is taken by mouth for 8 weeks. Study subjects with treatment failure will be provided an alternative DAA + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.