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Antiviral

Sofosbuvir/Velpatasvir for Kidney Transplant Recipients

Phase 2

Waitlist Available

Led By Amit Tevar, MD

Research Sponsored by Amit D Tevar, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

On chronic hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease (CKD) defined as a glomerular filtration rate < 15 ml/min

Patients with end-stage renal disease listed for kidney transplantation at UPMC.

Must not have

Known ongoing therapy for HCV

Known allergy to sofosbuvir/velpatasvir

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the safety and efficacy of transplanting kidneys from donors who are either hepatitis C seropositive and non-viremic, or seropositive and viremic, to recipients who are seronegative. Treatment and prophylaxis will be administered using a transmission-triggered approach for the first scenario and a prophylaxis approach for the later scenario.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of sofosbuvir/velpatasvir include headache, fatigue, nausea, insomnia and sometimes more serious reactions like slowed heartbeat or severe depression. The risk varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am on dialysis or have stage 5 kidney disease.

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

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I am 18 years old or older.

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My kidney's quality score is below 85.

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I have no health issues preventing me from getting a kidney transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving treatment for hepatitis C.

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I am allergic to sofosbuvir/velpatasvir.

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I have a history of liver cirrhosis.

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I have used amiodarone for atrial fibrillation in the last year.

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I have received an organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adverse Events

HCV free at 1 year

Side effects data

From 2019 Phase 4 trial • 11 Patients • NCT03235154

18%

GI distress

Suicidal Ideation

Fatigue

Scabies

Altered Mental Status

Seizure

Visual Hallucination

100%

80%

60%

40%

20%

Study treatment Arm

Single Arm Intervention

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: HCV seropositive viremic (HCV Ab+/NAT+) donorExperimental Treatment1 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-) donorExperimental Treatment1 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).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

sofosbuvir/velpatasvir

2017

Completed Phase 4

~20

0 / 10Eligibility criteria met