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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Adverse Events
HCV free at 1 year
Secondary outcome measures
All-cause mortality
Incidence of allograft rejection
Incidence of graft loss
+2 moreSide effects data
From 2019 Phase 4 trial • 11 Patients • NCT0323515418%
GI distress
9%
Scabies
9%
Altered Mental Status
9%
Seizure
9%
Visual Hallucination
9%
Suicidal Ideation
9%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm Intervention
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
Find a Location
Who is running the clinical trial?
Amit D Tevar, MDLead Sponsor
University of Pittsburgh Medical CenterOTHER
70 Previous Clinical Trials
76,220 Total Patients Enrolled
2 Trials studying Hepatitis C
495 Patients Enrolled for Hepatitis C
Fernanda Silviera, MDStudy DirectorUniversity of Pittsburgh
1 Previous Clinical Trials
73 Total Patients Enrolled
1 Trials studying Hepatitis C
73 Patients Enrolled for Hepatitis C
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are pregnant.I am on dialysis or have stage 5 kidney disease.I am on the kidney transplant list at UPMC with end-stage renal disease.I am currently receiving treatment for hepatitis C.You are on a waiting list for receiving multiple organs for transplantation.You don't have a living donor who can donate a kidney.You agree to use birth control for one year after the transplant.I am 18 years old or older.I am allergic to sofosbuvir/velpatasvir.You have a condition that could increase the risk of early failure of a kidney transplant, as determined by the doctors.You currently engage in behaviors that increase your risk of contracting Hepatitis C such as injection drug use or using illicit drugs through the nose or in an unregulated setting.I am on the kidney transplant list at UPMC with less than 60 months waiting or dialysis time.My kidney's quality score is below 85.I have no health issues preventing me from getting a kidney transplant.I have a history of liver cirrhosis.I have used amiodarone for atrial fibrillation in the last year.I can travel to UPMC for follow-up visits for at least a year after my transplant.I have received an organ transplant.You have a medical or mental condition that could make it unsafe for you to participate in the study or may affect your ability to participate.
Research Study Groups:
This trial has the following groups:- Group 1: HCV seropositive viremic (HCV Ab+/NAT+) donor
- Group 2: HCV seropositive non-viremic (HCV Ab+/NAT-) donor
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA cleared sofosbuvir/velpatasvir for use?
"There is some data supporting the safety of sofosbuvir/velpatasvir, but since this is only a Phase 2 trial, there is no evidence yet of efficacy. Therefore, it received a score of 2."
Answered by AI
How many research participants are being enrolled in this trial?
"Unfortunately, this trial is not recruiting patients right now. The listing was first posted on May 29th, 2019 and updated most recently on October 27th, 2021. However, if you are interested in other studies, there are 386 trials for hepatitis c and 31 trials for sofosbuvir/velpatasvir looking for participants."
Answered by AI
Are there any unfilled vacancies for people who want to participate in this research?
"This particular trial is no longer enrolling patients. Although, if you search for other hepatitis c trials, there are 386 clinical trials still looking for participants. Additionally, 31 studies focused on sofosbuvir/velpatasvir are actively recruiting right now."
Answered by AI
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