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Completed

NCT Number: NCT03801707

Utilization of Hepatitis C Positive Kidneys in Negative Recipients

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

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Key information

Conditions

Kidney Transplant Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections HCV Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Brenda Cuson

Columbus, Ohio, 43210, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]

Drug

fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C

Other names: Epclusa

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

Drug

Three tablets once a day for 12 weeks for treatment of hepatitis C

Other names: Mavyret

Primary outcomes

  1. Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment

    Time frame: 12 weeks

    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.

  2. Elevation in Liver Enzyme >5 Times the Upper Limits, Development of Acute Cholestatic Hepatitis , or Intolerance to Direct Acting Antiviral Therapies

    Time frame: 12 weeks

    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.

Secondary outcomes

  1. Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 Months Post-transplant

    Time frame: 6 and 12 months

    Estimated glomerular filtration rate (eGFR) at 6 and 12 months post-transplant was to test the safety of utilizing of HepC positive kidneys.

  2. Patient's Survival at 6 and 12 Months

    Time frame: 6 and 12 months

    Patient's survival at 6 and 12 months measuring safety of utilizing of HepC positive kidneys.

  3. Graft Survival at 6 and 12 Months

    Time frame: 12 months

    Graft survival at 6 and 12 months measuring safety of utilizing HepC positive kidneys.

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 11, 2019
Registry last updated
Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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