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Kidney TransplantationPhase 2NCT03809533

The Use of Hepatitis C Positive Kidneys in Hepatitis C Negative Kidney Transplant Recipients

A Phase 2 study testing sofosbuvir/velpatasvir in people with Kidney Transplantation and Hepatitis C, run by Amit D Tevar, MD at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open-label, pilot trial to test the safety and efficacy of transplantation of kidneys from hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the kidney transplant waitlist. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Kidney Transplantation, Hepatitis C
What is being tested?
sofosbuvir/velpatasvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
29 May 2019to 1 Apr 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with end-stage renal disease listed for kidney transplantation at UPMC.
  • On chronic hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease (CKD) defined as a glomerular filtration rate < 15 ml/min
  • Age ≥ 18
  • No available living kidney donor
  • Listed for an isolated kidney transplant at UPMC with <60m of accrued transplant waiting time and/or <60m of dialysis time
  • Have panel reactive antibody level of <98%
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  • No obvious contraindication to kidney transplant
  • Able to travel to UPMC for routine post-transplant visits and study visits for a minimum of 12 months after transplantation
  • Able to provide informed consent
  • Be willing to use a contraceptive method for a year after transplant
  • HCV antibody positive
  • HCV NAT negative or positive
  • Kidney donor profile index (KDPI) score <85

Who cannot join

  • HIV positive
  • HCVAb or HCV RNA positive
  • 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.
  • Hepatitis B surface antigen positive
  • History of liver cirrhosis
  • Persistently elevated liver transaminases, defined as ALT/AST at least 3 times the upper limit of normal for a minimum of 3 consecutive months
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  • History of atrial fibrillation requiring the use of amiodarone over the past 12m
  • Patients with etiology of renal failure with increased risk of causing early graft failure as assessed by the investigator team
  • Receipt of prior organ transplant
  • Waitlisted for a multi-organ transplant
  • Pregnant women
  • Known allergy to sofosbuvir/velpatasvir
  • 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
  • Confirmed HIV positive (positive HIV-1 antibody, positive HIV-2 antibody, positive p24 antigen and/or positive HIV NAT)
  • Confirmed HBV positive (positive hepatitis B surface antigen and/or HBV NAT)
  • Known ongoing therapy for HCV

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UPMC

    Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Official title: Transplantation of Kidneys of Hepatitis C (HCV) Seropositive Donors to HCV Seronegative Recipients With Subsequent Therapy With Sofosbuvir/Velpatasvir (Epclusa)

This is an open-label, pilot trial to test the safety and efficacy of transplantation of kidneys from hepatitis C seropositive non-viremic (HCV Ab+/NAT-) and HCV seropositive viremic (HCV Ab+/NAT+) donors to HCV seronegative recipients on the kidney transplant waitlist. Treatment and prophylaxis will be administered using a transmission-triggered approach for the first scenario (HCV Ab+/NAT- donors, arm 1) and a prophylaxis approach for the later scenario (HCV Ab+/NAT+ donors, arm 2).

Read the detailed description

This is a prospective, single center, pilot, open-label study of transplantation of kidneys of HCVAb+ donors to HCVAb- recipients with subsequent therapy with sofosbuvir/velpatasvir (Epclusa®). Recipients of a kidney from HCVAb+/NAT- donors will be in arm 1 (the transmission-triggered arm) of the study. In this arm, the study will monitor HCV by measuring HCV RNA in renal transplant recipients. If HCV RNA is detected, indicating transmission of HCV, recipients will be treated with sofosbuvir/velpatasvir (Epclusa®) for 12 weeks. Virological response will be assessed at 4 weeks, end of treatment and 12 weeks after completion of therapy.

Recipients of a kidney from HCVAb+/NAT+ donors will be in arm 2 (the prophylaxis arm) of the study. In this arm, patients will be started on a 12-week course of sofosbuvir/velpatasvir (Epclusa®) immediately post-operatively and will undergo close monitoring of HCV RNA for evidence of transmission.

To be eligible for the study, subjects need to be listed for renal transplantation, be not infected with HCV, HBV or HIV, and sign informed consent.

Being tested
sofosbuvir/velpatasvir
Medical subject headings
Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sofosbuvir/velpatasvirDrug

    Also called Epclusa

    12-week, oral, fixed-dose

Study groups in NCT03809533
Study groupRoleWhat they receive
HCV seropositive non-viremic (HCV Ab+/NAT-) donorExperimentalKidney recipients will be monitored for HCV for one year following transplant. When HCV RNA is detected, the transmission-triggered treatment phase will be initiated. Recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
HCV seropositive viremic (HCV Ab+/NAT+) donorExperimentalStarting post-operative day 1, kidney recipients will be treated with 12-week oral course of sofosbuvir/velpatasvir (Epclusa®), a fixed-dose combination of a nucleotide analogue HCV NS5B polymerase inhibitor (sofosbuvir - 400mg) and a NS5A inhibitor (velpatasvir - 100mg).
Receives: Drug: sofosbuvir/velpatasvir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Rate of adverse events due to sofosbuvir/velpatasvir (Epclusa) in patients in each experimental group

    Measured: 5 years

  2. HCV free at 1 year

    Proportion of participants in each experimental group who are free of HCV at 1 year following transplantation

    Measured: 1 year

Secondary outcomes (5)

  1. Transmission rate of HCV from HCVAb+/NAT- donors to HCVAb- recipients

    Measured: 5 years

  2. Incidence of allograft rejection

    Measured: 5 years

  3. Incidence of graft loss

    Measured: 5 years

  4. All-cause mortality

    Measured: 5 years

  5. Waitlist time after enrollment

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2019
  2. Study start29 May 2019
  3. Primary completion1 Apr 2026 (estimated)
  4. Study completion1 Apr 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03809533
Sponsor's protocol ID
STUDY19100135
Status last verified
Jul 2025
First submitted
15 Jan 2019
Last updated
6 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: We do not plan to share individual patient data outside of our investigative team. Aggregate data will be shared in publications as appropriate.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sofosbuvir/velpatasvir in people with Kidney Transplantation and Hepatitis C, run by Amit D Tevar, MD at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03809533.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2025.

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