Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

62

Participants

Timeline

Start Date

May 1, 2016

Primary Completion Date

March 31, 2022

Study Completion Date

December 31, 2022

Conditions
End Stage Renal Disease
Interventions
DRUG

Zepatier

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.

DRUG

Mavyret

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.

Trial Locations (1)

19104

Hospital of the University of Pennsylvania, Philadelphia

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

University of Pennsylvania

OTHER

NCT02743897 - Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients | Biotech Hunter | Biotech Hunter