Utilization of Hepatitis C Positive Kidneys in Negative Recipients

Ohio State University54 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Kidney Transplant Hepatitis C HCV

Interventions

Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]DRUG

fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C

Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]DRUG

Three tablets once a day for 12 weeks for treatment of hepatitis C

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Recipient Inclusion/Exclusion Criteria: 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 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%

Locations (1)

Brenda Cuson

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment

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.

Time frame: 12 weeks

Elevation in Liver Enzyme >5 Times the Upper Limits, Development of Acute Cholestatic Hepatitis , or Intolerance to Direct Acting Antiviral Therapies

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.

Time frame: 12 weeks

Secondary Outcomes

Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 Months Post-transplant

Estimated glomerular filtration rate (eGFR) at 6 and 12 months post-transplant was to test the safety of utilizing of HepC positive kidneys.

Time frame: 6 and 12 months

Patient's Survival at 6 and 12 Months

Patient's survival at 6 and 12 months measuring safety of utilizing of HepC positive kidneys.

Time frame: 6 and 12 months

Graft Survival at 6 and 12 Months

Graft survival at 6 and 12 months measuring safety of utilizing HepC positive kidneys.

Time frame: 12 months

Data from ClinicalTrials.gov

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