Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients

Phase 1

Completed

• Conditions: End Stage Renal Disease
• Interventions: Drug: Zepatier; Drug: Mavyret

• Registration Number: NCT02743897
• Lead Sponsor: University of Pennsylvania

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-15
• Study First Posted: 2016-04-19
• Study Start: 2016-05-01
• Primary Completion: 2022-03
• Study Completion: 2022-12
• Results First Submitted: 2023-05-16
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-14
• Last Update Submitted: 2023-06-14
• Results First Posted: 2023-06-15
• Last Update Posted: 2023-06-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Direct-acting antiviral treatment for HCV	Zepatier	-
Direct-acting antiviral treatment for HCV	Mavyret	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects Cured	Baseline to 24 weeks	Subjects with post-treatment sustained virologic response (SVR) = Number of subjects with negative HCV RNA 12 weeks after completing therapy / number of subjects treated post-kidney transplantation
Number of Subjects With SAE Attributable to HCV Therapy	Baseline to 52 weeks	Number of subjects with major adverse events attributable to HCV therapy in post-kidney transplant

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States