Utilization of Hepatitis C Positive Kidneys in Negative Recipients

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

Detailed Description
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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

Official Title
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An Open Label, Proof of Concept Study to Evaluate the Feasibility and Safety of Kidney Transplant From HCV Positive Donors Into HCV Negative Recipient

Conditions
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Kidney Transplant, Hepatitis C, HCV

Intervention / Treatment
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* Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]
* Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]


Participation Criteria
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Eligibility Criteria
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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%

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies. | Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]<br>* fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C<br>* Other names: Epclusa;Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]<br>* Three tablets once a day for 12 weeks for treatment of hepatitis C<br>* Other names: Mavyret;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 12 months |