Hepatitis C Positive Kidney Transplants for Kidney Failure

Recruiting in Palo Alto (17 mi)

Overseen by Michael E de Vera, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Loma Linda University

No Placebo Group

Approved in 2 Jurisdictions

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.

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

Treatment Details

Interventions

• Kidney Transplantation (Virus Therapy)

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).

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Adrian Cotton

Loma Linda University

Chief Medical Officer since 2020

MD

Richard H. Hart

Loma Linda University

Chief Executive Officer since 2015

MD, DrPH