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Could hepatitis c kidneys solve the organ shortage?

NCT ID NCT04075916

Disease control Sponsor: University of Pennsylvania Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether kidneys from deceased donors with hepatitis C can be safely transplanted into people without hepatitis C. All 201 participants received antiviral medication after transplant to clear any infection. The goal was to see if this approach could safely increase the number of available kidneys and reduce waiting times for transplant.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sofosbuvir/velpatasvir (Epclusa)
What this could lead to
If successful, this could expand the donor kidney pool, reducing wait times for people with end-stage kidney disease.
What could go wrong
This is a phase 2 trial with 201 participants, so results may not apply to everyone. There is a risk of hepatitis C transmission or other complications despite antiviral treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

201 people

The number who actually took part.

Started

Jun 2021

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Able to provide informed consent * Active waiting list status for isolated kidney transplant * 18 years of age or older * 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 or dronedarone (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, from a period starting 6 months prior to screening to last study visit, that the study PIs judge would interfere with either the aims or the safety of the THINKER-NEXT study.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease end stage renal failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

End stage renal disease

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Jackson Memorial Hospital/University of Miami

    Miami, Florida, 33136, United States

  • Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • New York Presbyterian Hospital/Columbia University

    New York, New York, 10032, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of Florida

    Gainesville, Florida, 32608, United States

  • Vanderbilt University

    Nashville, Tennessee, 37235, United States

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