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

31 Participants Needed

Trial Summary

What is the purpose of this trial?

To determine the efficacy and safety of transplanting HCV positive kidney allografts to HCV sero-negative patients who are on the waiting list.

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 data supports the effectiveness of this treatment for kidney transplantation in patients with kidney failure?

Research shows that kidney transplantation significantly improves survival rates for patients with kidney failure who are infected with hepatitis C, compared to remaining on dialysis. Additionally, the use of hepatitis C-positive donor kidneys, combined with antiviral treatments, has helped reduce waitlist times and address organ shortages. ^{1 2 3 4 5}

Is it safe to receive a kidney transplant from a hepatitis C-positive donor?

Receiving a kidney from a hepatitis C-positive donor can increase the risk of mortality, especially for recipients who are hepatitis C-negative. However, for hepatitis C-positive recipients, using kidneys from hepatitis C-positive donors may be considered, as it can improve survival compared to remaining on dialysis, though there is still a potential risk involved. ^{4 5 6 7 8}

How is the treatment of kidney transplantation using hepatitis C positive kidneys different from other treatments for kidney failure?

This treatment is unique because it involves using kidneys from hepatitis C positive donors, which were previously discarded, and treating recipients with direct-acting antivirals post-transplant. This approach helps reduce waitlist times and addresses organ shortages, offering a viable option for patients with kidney failure. ^{3 4 6 7 9}

Research Team

Michael E de Vera, MD

Principal Investigator

Loma Linda University Health

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

1. Denmark pubmed.ncbi.nlm.nih.gov

Renal transplantation offers a better survival in HCV-infected ESRD patients. [2022]

2. Denmark pubmed.ncbi.nlm.nih.gov

Kidney transplantation and waitlist mortality rates among candidates registered as willing to accept a hepatitis C infected kidney. [2018]

3. Turkey pubmed.ncbi.nlm.nih.gov

Outcomes After Direct-Acting Antiviral Therapy Based on Donor Hepatitis C Serostatus Among Hepatitis C Virus-Infected Kidney Transplant Recipients. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Shorter waitlist times and improved graft survivals are observed in patients who accept hepatitis C virus+ renal allografts. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Donor hepatitis C seropositivity: clinical correlates and effect on early graft and patient survival in adult cadaveric kidney transplantation. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Antithymocyte Globulin Versus Interleukin-2 Receptor Antagonist in Kidney Transplant Recipients With Hepatitis C Virus. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Lack of impact of hepatitis C virus infection on graft survival after kidney transplantation--a Portuguese single-center experience. [2018]

8. United States pubmed.ncbi.nlm.nih.gov

Current status of renal transplantation from HCV-positive donors. [2019]

9. Iran pubmed.ncbi.nlm.nih.gov

Hepatitis C virus infection and kidney transplantation: a review for clinicians. [2010]