Could hepatitis C-Positive kidneys be safe for transplant?
NCT ID NCT03809533
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 Hide 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
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