Sofosbuvir/Velpatasvir for Kidney Transplant Recipients

Recruiting in Palo Alto (17 mi)

Overseen by Amit Tevar, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Amit D Tevar, MD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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).

Research Team

Amit Tevar, MD

Principal Investigator

University of Pittsburgh

Fernanda Silviera, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

This trial is for adults over 18 with end-stage renal disease on the kidney transplant waitlist at UPMC, without a living donor, and willing to use contraception post-transplant. Excluded are pregnant women, those with liver cirrhosis or certain heart conditions, HIV/HBV positive individuals, previous organ transplants recipients, or anyone with contraindications as assessed by investigators.

Inclusion Criteria

I am on dialysis or have stage 5 kidney disease.

I am on the kidney transplant list at UPMC with end-stage renal disease.

You don't have a living donor who can donate a kidney.

Exclusion Criteria

You are pregnant.

I am currently receiving treatment for hepatitis C.

You are on a waiting list for receiving multiple organs for transplantation.

Treatment Details

Interventions

• sofosbuvir/velpatasvir (Antiviral)

Trial Overview The trial tests if kidneys from hepatitis C positive donors can be safely transplanted into hepatitis C negative patients using sofosbuvir/velpatasvir for prevention and treatment of potential HCV transmission. It's an open-label study comparing two approaches based on the donor's viral status.

Participant Groups

Group I: HCV seropositive viremic (HCV Ab+/NAT+) donor Experimental Treatment 1 Intervention

Starting 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).

Group II: HCV seropositive non-viremic (HCV Ab+/NAT-) donor Experimental Treatment 1 Intervention

Kidney 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).

Who Is Running the Clinical Trial?

Amit D Tevar, MD

Lead Sponsor

Trials

1

Recruited

30+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

Leslie C. Davis

University of Pittsburgh Medical Center

Chief Executive Officer since 2021

BA in Economics from Wesleyan University, MBA in Health Administration from The Wharton School

Don Yealy

University of Pittsburgh Medical Center

Chief Medical Officer since 2023

MD from the Pritzker School of Medicine, University of Chicago