Hepatitis C Positive Kidney Transplants for Kidney Failure

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Must not be taking: DAA, RBV

Disqualifiers: HIV, Pregnancy, Breastfeeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the safety and effectiveness of transplanting kidneys from hepatitis C (HCV) positive donors to patients without hepatitis C. Researchers seek to assess whether these kidneys can benefit patients on the transplant waiting list and if any resulting hepatitis C infection can be successfully treated afterward. The trial focuses on patients currently waiting for a kidney transplant who have never had hepatitis C or had it previously but no longer do. As an unphased trial, it offers patients the chance to contribute to groundbreaking research that could expand kidney donor options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this kidney transplantation is safe for HCV sero-negative patients?

Research has shown that receiving a kidney from a donor with Hepatitis C (HCV) and treating it with antiviral drugs can be safe. One study found that this method produced excellent results over one year. However, risks exist. Without treatment, HCV can cause liver disease and other health issues. Participants in these trials must receive the necessary antiviral treatment to manage these risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using hepatitis C positive kidneys for transplants in patients with kidney failure because it expands the donor pool, potentially reducing wait times for transplants. Most kidney transplants rely on hepatitis C negative donors, limiting available organs. By using kidneys from hepatitis C positive donors and treating recipients with antiviral therapy shortly after transplantation, this approach makes more kidneys available for those in need. This method could significantly increase access to life-saving transplants while effectively managing the risk of hepatitis C transmission.

What evidence suggests that kidney transplantation of HCV positive kidneys is effective for kidney failure?

In this trial, participants will receive a kidney from a donor with Hepatitis C (HCV). Research has shown that this approach can be safe and effective for patients without the virus. Specifically, studies found that patients who received kidneys from HCV-positive donors and took antiviral medication maintained good kidney function and quality of life one year after their transplant. These patients were also cured of HCV, with the virus eliminated from their bodies. The use of specific antiviral drugs after the transplant has been crucial to these positive outcomes. Overall, evidence supports that this method works well for patients with kidney failure and offers a hopeful option for those considering it. ^{2 5 6 7 8}

Who Is on the Research Team?

Michael E de Vera, MD

Principal Investigator

Loma Linda University Health

Are You a Good Fit for This Trial?

This trial is for adults on the kidney transplant waiting list who don't have Hepatitis C. They can receive a kidney from donors who were positive for HCV, including those previously treated for HCV with undetectable viral load. Participants must be able to consent and speak English or Spanish. Those with HIV, pregnant or breastfeeding women, and individuals allergic to certain antiviral drugs are excluded.

Inclusion Criteria

I am either male or female.

I am on the waiting list for a kidney transplant.

The donor organ I received tested positive for HCV.

Exclusion Criteria

You are allergic or very sensitive to DAA or RBV.

You have HIV along with the condition being studied.

Pregnancy and/or actively breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation

Participants receive an HCV positive kidney allograft

1 day

1 visit (in-person)

Antiviral Treatment

Antiviral therapy starts within 3 months post-transplant unless clinical circumstances dictate otherwise

Up to 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Kidney Transplantation

Trial Overview The study is testing the safety and effectiveness of transplanting kidneys from donors with Hepatitis C into patients without the virus who need a kidney transplant. The goal is to see if this approach works well and doesn't cause harm.

How Is the Trial Designed?

Group I: Recipient of HCV positive kidney graft Experimental Treatment 1 Intervention

A single center, open-label, pilot study examining 20 adult HCV negative kidney transplant patients who receive an HCV infected graft. Target start date for antiviral therapy will be within 3 months after kidney transplantation, unless extenuating clinical circumstances arise (such as the development of fibrosing cholestatic HCV, which would prompt earlier treatment, or clinical events or comorbidities which would prompt delay in treatment).

Kidney Transplantation is already approved in United States, European Union for the following indications:

Approved in United States as Kidney Transplantation for:

• End-stage renal disease (ESRD) in HIV-positive patients

Approved in European Union as Kidney Transplantation for:

• Chronic kidney disease in HIV-positive patients
• End-stage renal disease (ESRD) in HIV-positive patients

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3132687/

Hepatitis C and Kidney Transplantation - PMC Hepatitis C virus (HCV) infection is relatively common among patients with end-stage kidney disease (ESKD) on dialysis and kidney transplant recipients.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0272638697903450

The impact of renal transplantation on survival in hepatitis ... Our study showed that HCVpositive renal transplant recipients had a better survival than similar HCV-positive patients awaiting transplantation. Previous ...

3. nature.com nature.com/articles/s41598-025-15169-4

High risk of hepatic complications in kidney transplantation ... HCV infection has been demonstrated to possibly adversely affect long-term outcomes of kidney transplantation because of post-transplant renal ...

4. ajkd.org ajkd.org/article/S0272-6386(23)00592-9/fulltext

A Systematic Review for the KDIGO 2022 Hepatitis C ... Kidney transplantation from HCV-infected deceased donors to uninfected recipients treated with DAA appears safe and effective.

5. acpjournals.org acpjournals.org/doi/10.7326/M18-0749

Twelve-Month Outcomes After Transplant of Hepatitis C– ... Conclusion: Twenty HCV-negative recipients of HCV-infected kidneys experienced HCV cure, good quality of life, and excellent renal function. Kidneys from HCV- ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6815878/

Hepatitis C virus infection in kidney transplantation- ... This can result in an acute on chronic flare of hepatitis, and an increased risk of cirrhosis as well as hepatocellular carcinoma after transplantation. Also, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955470X21000835

Hepatitis C virus and kidney transplantation: Recent trends ... However, HCV also adversely affects post-transplant outcomes for kidney recipients increasing risks of graft loss and all-cause mortality [4]. Historically, ...

8. hcvguidelines.org hcvguidelines.org/guidance/treatment-of-hcv-uninfected-transplant-recipients-receiving-organs-from-hcv-viremic-donors/

Treatment of HCV-Uninfected Transplant Recipients ... Risk of liver disease if HCV treatment is not available or treatment is unsuccessful; Risk of graft failure; Risk of extrahepatic complications, ...