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Utilization of Hepatitis C Positive Kidneys in Negative Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03801707
Recruitment Status : Completed
First Posted : January 11, 2019
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
Reem Daloul, Ohio State University

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

Condition or disease Intervention/treatment Phase
Kidney Transplant Hepatitis C HCV Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa] Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET] Phase 2 Phase 3

Detailed 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
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 22, 2019
Actual Primary Completion Date : April 28, 2021
Actual Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Intervention group
kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
 Drug: Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]
fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C
Other Name: Epclusa

Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]
Three tablets once a day for 12 weeks for treatment of hepatitis C
Other Name: Mavyret


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients with undetectable HCV polymerase chain reaction (PCR) at 12 weeks after completion of HCV treatment with Sofosbuvir/Velpatasvir [ Time Frame: 12 weeks ]
    Efficacy

  2. The incidence of adverse events related to Sofosbuvir/Velpatasvir drug therapy [ Time Frame: 12 weeks ]
    safety


Secondary Outcome Measures :
  1. Estimated glomerular filtration rate (eGFR) at 6 and 12 months post-transplant [ Time Frame: 6 and 12 months ]
    Safety

  2. Patient's survival at 6 and 12 months [ Time Frame: 6 and 12 months ]
    Safety

  3. Graft survival at 12 months [ Time Frame: 12 months ]
    Safety


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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), HCV, and hepatitis B virus (HBV) serology and blood HCV 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%
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03801707


Locations
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United States, Ohio
Brenda Cuson
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Reem Daloul, MD Ohio State University School of Biomedical Science: The Ohio State University College of Medicine
More Information
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Additional Information:

Publications:

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Responsible Party: Reem Daloul, Assistant Professor of Clinical Medicine, Transplant Nephrology, Ohio State University
ClinicalTrials.gov Identifier: NCT03801707    
Other Study ID Numbers: 2018H0499
First Posted: January 11, 2019    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Infections
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Sofosbuvir
Sofosbuvir-velpatasvir drug combination
Velpatasvir
Antiviral Agents
Anti-Infective Agents