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A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients (THINKER-NEXT)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075916
Recruitment Status : Not yet recruiting
First Posted : September 3, 2019
Last Update Posted : July 10, 2020
Sponsor:
Collaborators:
Gilead Sciences
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The Transplanting Hepatitis C Kidneys into Negative KidnEy Recipients [THINKER-NEXT] study will include adult kidney transplant candidates without hepatitis C virus (HCV) infection on the transplant waiting list who will consent to kidney transplantation from a deceased donor infected with HCV, followed by treatment with a direct acting antiviral. The one-year allograft function and one-year risk of CMV infection will be compared between THINKER-NEXT kidney transplant recipients and matched recipients who received hepatitis C uninfected kidney transplants (these patients are called Transplant Cohort). The mortality rate of kidney transplant candidates who enroll in THINKER-NEXT and consent to offers of kidneys from HCV-infected donors will be compared to matched wait-listed patients who do not consent to receive HCV-infected kidneys (these patients are called Wait-list Cohort). Lastly, renal pathologic findings will be compared among HCV-viremic donors and HCV-negative comparator donors.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Drug: Epclusa Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

Arm Intervention/treatment
Experimental: Epclusa (sofosbuvir/velpatasvir)
Epclusa is taken by mouth for 12 weeks as per the FDA label.
Drug: Epclusa
All patients will receive 12 weeks of sofosbuvir/velpatasvir as per the FDA label.




Primary Outcome Measures :
  1. Post-treatment sustained virologic response (SVR) to direct-acting antiviral (DAA) [ Time Frame: Baseline to 24 weeks ]
    The primary analysis will be based on a calculation of SVR rates (number of subjects with SVR-12; negative HCV RNA 12 weeks after completing Epclusa therapy)/(number of subjects treated with Epclusa post-kidney transplantation)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Able to provide informed consent
  • Active waiting list status for isolated kidney transplant
  • 18 to 70 years of age
  • No living kidney donor
  • Panel reactive antibody ≤97%
  • Agreement for participation from patient's transplant nephrologist

Exclusion Criteria:

  • Hepatocellular carcinoma
  • Hepatitis B surface antigen and/or DNA positive
  • HCV nucleic acid test (NAT) positive (an isolated positive HCV Ab is not an exclusion)
  • HIV RNA-positive or HIV antibody positive
  • Other chronic liver disease (excluding non-alcoholic fatty liver disease [NAFLD] with normal liver enzymes)
  • Persistently elevated liver transaminases (defined as the upper limit of normal at the reference laboratory)
  • Significant hepatic fibrosis on screening elastography (Fibroscan value ≥8kPa; equates to >F2 fibrosis on the Metavir staging system
  • Primary Focal Segmental Glomerulosclerosis (FSGS), FSGS recurring in initial transplant, or other disease process at high risk of early graft failure per the treating transplant nephrologist
  • Current use of amiodarone (due to interaction with sofosbuvir)
  • Transplant candidate requires antibody desensitization protocol for transplantation
  • Female who is pregnant, planning to become pregnant during the study, or breast-feeding
  • Participation in another interventional study of any investigational agent or approved medication, or participation in another kind interventional study that the responsible investigator deems to be an exclusion from period 6 months prior to screening to last study visit

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): NCT04075916


Contacts
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Contact: Peter Reese, MD, MSCE (307) 22-THINK thinker@med.upenn.edu
Contact: Stacey Prenner, MD (307) 22-THINK thinker@med.upenn.edu

Locations
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United States, Florida
Jackson Memorial Hospital/University of Miami
Miami, Florida, United States, 33136
Contact: David Goldberg, MD, MSCE       dsgoldberg@med.miami.edu   
Contact: Javier Pagan, MD       jap88@miami.edu   
Principal Investigator: David Goldberg, MD, MSCE         
United States, Maryland
Johns Hopkins
Baltimore, Maryland, United States, 21287
Contact: Christine Durand, MD       ChristineDurand@jhmi.edu   
Contact: Dorry Segev, MD, PhD       dorry@jhmi.edu   
Principal Investigator: Christine Durand, MD         
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Contact: Raymond Chung, MD       rtchung@partners.org   
Contact: Meghan Sise, MD       msise@partners.org   
Principal Investigator: Raymond Chung, MD         
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63110
Contact: William Chapman, MD, FACS       chapmanw@wustl.edu   
Principal Investigator: William Chapman, MD, FACS         
United States, New York
New York Presbyterian Hospital/Columbia University
New York, New York, United States, 10032
Contact: Elizabeth Verna, MD       ev77@cumc.columbia.edu   
Contact: Sumit Mohan, MD       sm2206@cumc.columbia.edu   
Principal Investigator: Elizabeth Verna, MD         
United States, Ohio
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Contact: Steve Woodle, MD       steve.woodle@uc.edu   
Principal Investigator: Steve Woodle, MD         
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Vanderbilt University
Nashville, Tennessee, United States, 37235
Contact: David Shaffer, MD, FACS       david.shaffer@vumc.org   
Contact: Rachel Forbes, MD, MBA       rachel.forbes@vumc.org   
Principal Investigator: David Shaffer, MD, FACS         
Sponsors and Collaborators
University of Pennsylvania
Gilead Sciences
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04075916    
Other Study ID Numbers: 10067385
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: July 10, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Kidney Failure, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Sofosbuvir-velpatasvir drug combination
Antiviral Agents
Anti-Infective Agents