Utilization of Hepatitis C Positive Kidneys in Negative Recipients

Phase 2

Completed

• Conditions: Kidney Transplant; HCV; Hepatitis C
• Interventions: Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]; Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]

• Registration Number: NCT03801707
• Lead Sponsor: Ohio State University

Brief Summary

To evaluate the safety and feasibility of transplanting kidneys from Hepatitis C virus (HCV) infected donors into recipients without HCV infection

Detailed Description

This will be an open label, prospective, interventional, proof of concept study to evaluate the feasibility and safety of kidney transplant from HCV positive donors into HCV negative recipients using treatment with pan-genotypic direct acting antiviral therapies (DAAS) for treatment of post-transplant HCV transmission

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: 2019-01-09
• Study First Submitted QC: 2019-01-10
• Study First Posted: 2019-01-11
• Study Start: 2019-03-22
• Primary Completion: 2021-04-28
• Study Completion: 2021-04-30
• Results First Submitted: 2023-04-14
• Status Verified: 2023-08
• Results First Submitted QC: 2023-08-30
• Last Update Submitted: 2023-08-30
• Results First Posted: 2023-09-13
• Last Update Posted: 2023-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Adult age >18 years able to provide consent
• Lack of available living donor
• Calculated pre-transplant reactive panel (cPRA) of <80%
• Estimated post-transplant survival (EPTS) index >20% and <80%
• Negative pre-transplant human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) serology and blood HCV polymerase chain reaction (PCR)
• No clinically significant pre-transplant liver disease

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Exclusion Criteria

• Living donor available
• Dialysis time >5 years
• Listing for multi-organ transplantation
• Active or recent history (<6 months) of alcohol abuse or substance abuse
• Clinically significant liver disease as determined by principal investigator
• History of hepatocarcinoma
• Pregnancy or lactation
• Refusal to accept blood transfusion
• HIV infection
• HCV pcr or antibody positive
• HBV infection

Donor Inclusion Criteria:

• Positive HCV PCR at time of donation
• Kidney donor profile index (KDPI)<85%

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention group	Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]	kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
Intervention group	Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]	kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment	12 weeks	Proportion of patients with undetectable hepatitis C virus (HCV) polymerase chain reaction (PCR) at 12 weeks after completion of HCV treatment was to test the efficacy of the treatment.
Elevation in Liver Enzyme >5 Times the Upper Limits, Development of Acute Cholestatic Hepatitis , or Intolerance to Direct Acting Antiviral Therapies	12 weeks	Elevation in liver enzyme \>5 times the upper limits, development of acute cholestatic hepatitis , or intolerance to Direct acting antiviral therapies was to test the safety of utilizing HepC positive kidneys for transplant.

Secondary Outcome Measures

Name	Time	Method
Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 Months Post-transplant	6 and 12 months	Estimated glomerular filtration rate (eGFR) at 6 and 12 months post-transplant was to test the safety of utilizing of HepC positive kidneys.
Patient's Survival at 6 and 12 Months	6 and 12 months	Patient's survival at 6 and 12 months measuring safety of utilizing of HepC positive kidneys.
Graft Survival at 6 and 12 Months	12 months	Graft survival at 6 and 12 months measuring safety of utilizing HepC positive kidneys.

Trial Locations

Locations (1)

Brenda Cuson; 🇺🇸 Columbus, Ohio, United States