Multi-center Study to Transplant Hepatitis-C Infected Kidneys



Status:Not yet recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases, Nephrology / Urology
Healthy:No
Age Range:35 - 65
Updated:1/2/2019
Start Date:March 30, 2019
End Date:December 31, 2022
Contact:Raymond T Chung, MD
Email:chung.raymond@mgh.harvard.edu
Phone:617-724-7562

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A Multi-Center, Open-Label Study of Glecaprevir/Pibrentasvir to Treat Recipients of Transplanted Kidneys From Deceased Donors With Hepatitis C Virus

Open label multi center study for the donation of HCV positive kidneys to HCV negative
recipients with interventional treatment to prevent HCV transmission upon transplantation.

The study objective is to determine if the administration of the direct acting antiviral
glecaprevir/pibrentasvir for 8 weeks after kidney transplantation is both safe and effective
at preventing the spread of HCV infection from donor kidney with known HCV infection (all
genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks
post treatment.

Inclusion Criteria:

- Estimated glomerular filtration rate(eGFR) < 15 ml/min/1.73 m2

- Blood group O, A, or B

- Listed for an isolated kidney transplantation

- Waiting list priority time

1. For blood group O or B patients: <912 days of accrued waiting list priority time

2. For blood group A patients: <730 days of accrued waiting list priority time

- Able to understand and adhere to the study visit schedule and all other protocol
requirements, and must voluntarily sign and date an informed consent

- No available medically acceptable, compatible living kidney donor

- Subject must agree to use an effective method of birth control per protocol
specifications

Exclusion Criteria:

- History of severe, life-threatening or other significant sensitivity to
immunosuppressants utilized in kidney transplant

- Female who is pregnant, breastfeeding, or is planning to become pregnant during the
course of the study

- History of HIV

- HCV RNA positive

- HBV surface Ag-positive or detectable HBV DNA

- Primary focal segmental glomerulosclerosis (FSGS) or disease process with increased
risk of causing early graft failure as assessed by the transplant nephrologist and/or
investigator team

- Presence of clinically significant liver disease

- Transplant candidate requiring antibody desensitization protocol for transplantation

- Most recent calculated panel reactive antibody (cPRA) >80%.

- Prior recipient of a non-renal solid organ transplant
We found this trial at
7
sites
500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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Boston, MA
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
University of Cincinnati Medical Center Opening in 1823 as the country
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Baltimore, Maryland 21287
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Chicago, Illinois 60611
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New York, New York 10065
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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Philadelphia, PA
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