Utilization of Hepatitis C Positive Kidneys in Negative Recipients



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:January 9, 2019
End Date:January 2022
Contact:Reem Daloul, MD
Email:Reem.Daloul@osumc.edu
Phone:614-293-4665

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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 Recipient Using Sofosbuvir/Velpatasvir as a Treatment for Post-Transplant HCV Transmission

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 Sofosbuvir/Velpatasvir as a treatment for post-transplant HCV transmission

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 HIV, HCV, and HBV serology and blood HCV PCR

- No clinically significant pre-transplant liver disease

- Pre-enrollment approval by patient's insurance to cover DAAs therapy

- Contraception based on the REMS protocol

- Agree to abstinence form alcohol for at least 6 months post-transplant

Exclusion Criteria:

- Living donor available Dialysis time >5 years History of previous organ
transplantation Listing for multi-organ transplantation Active or recent history (<6
months) of alcohol 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

- KDPI<85%
We found this trial at
1
site
410 W 10th Ave
Columbus, Ohio 43210
(614) 293-8652
Principal Investigator: Reem Daloul
Phone: 614-293-4665
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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Columbus, OH
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