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Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients — THINKER  

End Stage Renal Disease Clinical Trial

Official title:
Open-Labeled Trial Of Direct-Acting Antiviral Treatment Of Hepatitis C-Negative Patients Who Receive Kidney Transplants From Hepatitis C-Positive Donors

Clinical Trial 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.

Clinical Trial Description

Open-labelled pilot clinical trial of Zepatier (Grazoprevir + Elbasvir), Mavyret (Glecaprevir + Pibrentasvir), Epclusa (Sofosbuvir + Velpatasvir), or another appropriate DAA in at least 75 HCV-negative subjects with end-stage renal disease receiving a kidney transplant from a HCV-positive donor. Eligible subjects will receive a kidney transplant from a deceased-donor, and then will receive DAA treatment after kidney transplantation when infection with HCV is confirmed in these kidney transplant recipients. Treatment will be complete after 12 weeks for most subjects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02743897
Study type Interventional
Source University of Pennsylvania
Contact
Status Completed
Phase Phase 1/Phase 2
Start date May 1, 2016
Completion date December 2022
View Details
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