Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients

  • STATUS
    Recruiting
  • End date
    Dec 27, 2022
  • participants needed
    75
  • sponsor
    University of Pennsylvania
Updated on 27 January 2021
kidney transplant
dialysis

Summary

This study is being conducted to determine safety and effectiveness of transplanting kidneys from Hepatitis C-positive donors into Hepatitis C-negative patients on the kidney transplant waitlist, who will then be treated with the appropriate direct-acting antiviral (DAA) after the single kidney transplantation.

Description

Open-labelled pilot clinical trial of Zepatier (Grazoprevir + Elbasvir), Mavyret (Glecaprevir + Pibrentasvir), Epclusa (Sofosbuvir + Velpatasvir), or another appropriate DAA in at least 75 HCV-negative subjects with end-stage renal disease receiving a kidney transplant from a HCV-positive donor. Eligible subjects will receive a kidney transplant from a deceased-donor, and then will receive DAA treatment after kidney transplantation when infection with HCV is confirmed in these kidney transplant recipients. Treatment will be complete after 12 weeks for most subjects.

Details
Condition Chronic renal failure, Stage 5 Chronic Kidney Disease, Chronic Kidney Disease Stage 5, CKD Stage 5, end stage renal disease, chronic renal disease, end-stage renal disease, esrd, end-stage renal failure, end stage kidney disease, end stage renal failure
Treatment Zepatier, Mavyret
Clinical Study IdentifierNCT02743897
SponsorUniversity of Pennsylvania
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 30 yrs and 65 yrs?
Gender: Male or Female
Do you have Chronic renal failure?
Is your age between 30 yrs and 70 yrs?
Do you have any of these conditions: end stage renal failure or chronic renal disease or end-stage renal failure or end stage renal disease or CKD Stage 5 or end-stage renal disease or en...?
Is your age between 30 yrs and 70 yrs?
Do you have any of these conditions: CKD Stage 5 or Chronic renal failure or end stage kidney disease or end stage renal disease or end stage renal failure or chronic renal disease or end...?
Is your age between 30 yrs and 70 yrs?
Do you have any of these conditions: Chronic renal failure or Chronic Kidney Disease Stage 5 or Stage 5 Chronic Kidney Disease or end-stage renal disease or end-stage renal failure or esr...?
Detectable HCV RNA
Age 60 years
Study modified Kidney donor profile index (KDPI) score 0.856 - calculated as if the kidney were HCV-negative (<https://optn.transplant.hrsa.gov/resources/allocation-calculators/kdpi-calculator/>)

Exclusion Criteria

Anatomical issues in the kidney allograft that raise the risk of post-transplant complications (e.g., number or length of renal arteries or veins)
Confirmed HIV positive
Confirmed HBV positive (positive Hepatitis B surface antigen and/or HBV DNA)
Known previously failed treatment for HCV using a regimen with a direct-acting antiviral (can have received interferon monotherapy and/or interferon + ribavirin combination therapy)
Clear my responses

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