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Could hepatitis C-Positive kidneys be safe for transplant?

NCT ID NCT03809533

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether kidneys from donors with hepatitis C can be safely transplanted into people without the virus. Recipients will take the antiviral drug Epclusa for 12 weeks to prevent or treat infection. The goal is to see if this approach is safe and effective, potentially increasing the number of available kidneys 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 pool for kidney transplants by safely using organs from hepatitis C-positive donors.
What could go wrong
This is a small, early-phase trial with only 30 participants, so results may not apply broadly. There is a risk of HCV transmission or side effects from the antiviral drug.

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

30 people

The number who actually took part.

Started

May 2019

Expected to finish

Apr 2026

An estimate. End dates often move.

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 (recipients): 1. Patients with end-stage renal disease listed for kidney transplantation at UPMC. 2. On chronic hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease (CKD) defined as a glomerular filtration rate \< 15 ml/min 3. Age ≥ 18 4. No available living kidney donor 5. Listed for an isolated kidney transplant at UPMC with \<60m of accrued transplant waiting time and/or \<60m of dialysis time 6. Have panel reactive antibody level of \<98% 7. No obvious contraindication to kidney transplant 8. Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation 9. Able to provide informed consent 10. Be willing to use a contraceptive method for a year after transplant Exclusion criteria (recipients): 1. HIV positive 2. HCVAb or HCV RNA positive 3. Presence of behavioral risk factors for contracting HCV other than being on hemodialysis. These behavioral risk factors are current injection drug use, current intranasal illicit drug use, current percutaneous/parenteral exposures in an unregulated setting. 4. Hepatitis B surface antigen positive 5. History of liver cirrhosis 6. Persistently elevated liver transaminases, defined as ALT/AST at least 3 times the upper limit of normal for a minimum of 3 consecutive months 7. History of atrial fibrillation requiring the use of amiodarone over the past 12m 8. Patients with etiology of renal failure with increased risk of causing early graft failure as assessed by the investigator team 9. Receipt of prior organ transplant 10. Waitlisted for a multi-organ transplant 11. Pregnant women 12. Known allergy to sofosbuvir/velpatasvir 13. Any condition, psychiatric or physical, that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study Inclusion criteria (donors): 1. HCV antibody positive 2. HCV NAT negative or positive 3. Kidney donor profile index (KDPI) score \<85 Exclusion criteria (donors): 1. Confirmed HIV positive (positive HIV-1 antibody, positive HIV-2 antibody, positive p24 antigen and/or positive HIV NAT) 2. Confirmed HBV positive (positive hepatitis B surface antigen and/or HBV NAT) 3. Known ongoing therapy for HCV

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • UPMC

    Pittsburgh, Pennsylvania, 15213, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.