Utilization of Hepatitis C Positive Kidneys in Negative Recipients

The Ohio State University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Hepatitis C; HCV; Kidney Transplant

Treatments: Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]; Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]

Study type: Interventional

Funder types: Other

Identifiers

NCT03801707

2018H0499

Details and patient eligibility

About

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

Full 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

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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%

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

Intervention group

Experimental group

Description:

kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.

Treatment:

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

Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]