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

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT04075916
Collaborator
Gilead Sciences (Industry), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
400
Enrollment
7
Locations
1
Arm
53.3
Anticipated Duration (Months)
57.1
Patients Per Site
1.1
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 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
Actual Study Start Date :
Jun 22, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Post-treatment sustained virologic response (SVR) to direct-acting antiviral (DAA) [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 (PRA) ≤97% (most recent cPRA at time of screening). Patients with a PRA of 98-100% at screening can be included unless patient has a most recent cytotoxic PRA of >25% or calculated PRA >50% where multiple moderate level HLA antibodies exist and in the opinion of the local site investigator represents substantial HLA sensitization. If patient has a PRA of 98-100%, the donor-recipient pair must meet additional eligibility criteria.

Exclusion Criteria:

  • Hepatocellular carcinoma

  • Hepatitis B surface antigen and/or DNA positive

  • Active Hepatitis C infection

  • 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)

  • Advanced hepatic fibrosis or cirrhosis

  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jackson Memorial Hospital/University of Miami Miami Florida United States 33136
2 Johns Hopkins Baltimore Maryland United States 21287
3 Massachusetts General Hospital Boston Massachusetts United States 02114
4 New York Presbyterian Hospital/Columbia University New York New York United States 10032
5 University of Cincinnati Cincinnati Ohio United States 45267
6 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
7 Vanderbilt University Nashville Tennessee United States 37235

Sponsors and Collaborators

  • University of Pennsylvania
  • Gilead Sciences
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Peter Reese, MD, MSCE, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT04075916
Other Study ID Numbers:
  • 10067385
  • U01DK126654
First Posted:
Sep 3, 2019
Last Update Posted:
Jul 12, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Hepatitis C
Hepatitis
Kidney Failure, Chronic
Sofosbuvir-velpatasvir drug combination

Study Results

No Results Posted as of Jul 12, 2022