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Direct Acting Antiviral

Hepatitis C Kidneys Transplantation for Kidney Failure (THINKER-NEXT Trial)

Phase 2
Recruiting
Led By Peter Reese, MD, MSCE
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Active waiting list status for isolated kidney transplant
18 years of age or older
Must not have
Other chronic liver disease (excluding non-alcoholic fatty liver disease [NAFLD] with normal liver enzymes)
Hepatocellular carcinoma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether it is safe to transplant kidneys from donors with hepatitis C into recipients who do not have the virus. One-year allograft function and one-year risk of CMV infection will be compared between THINKER-NEXT kidney transplant recipients and matched recipients who received hepatitis C uninfected kidney transplants. The mortality rate of kidney transplant candidates who enroll in THINKER-NEXT and consent to offers of kidneys from HCV-infected donors will be compared to matched wait-listed patients who do not consent to receive HCV-infected kidneys. Lastly, renal pathologic findings will be compared among HC

Who is the study for?
Adults on the kidney transplant waiting list without hepatitis C can join this trial. They must be over 18, have no living kidney donor, and a low to moderate immune response to potential donors (PRA ≤97%). Pregnant women, those planning pregnancy or breastfeeding, patients with certain heart medications or other liver diseases are excluded.
What is being tested?
The study tests if kidneys from deceased donors with Hepatitis C can be safely transplanted into patients without Hepatitis C. After transplantation, recipients will receive Epclusa to treat the virus. Their health outcomes will be compared with those who received non-HCV infected kidneys and those on the waitlist.
What are the potential side effects?
Epclusa may cause headaches, fatigue, nausea and trouble sleeping. It might also interact with other drugs leading to more side effects. The risk of organ inflammation is present due to HCV infection but is treated during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on the active waiting list for a kidney transplant.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a chronic liver condition, but it's not NAFLD with normal enzymes.
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I have been diagnosed with liver cancer.
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I have FSGS or a high risk of early graft failure according to my kidney doctor.
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I have tested positive for Hepatitis B.
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I have an active Hepatitis C infection.
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I am not pregnant, planning to become pregnant, or breastfeeding during the study.
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I am not taking amiodarone or dronedarone.
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I need a special treatment to prepare my body for a transplant.
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I have severe liver scarring or cirrhosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-treatment sustained virologic response (SVR) to direct-acting antiviral (DAA)

Side effects data

From 2019 Phase 2 & 3 trial • 10 Patients • NCT02825212
40%
Increased fatigue
30%
nausea and abdominal pain
20%
Urinary frequency and/or dysuria
10%
Herpes Zoster
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pts With Hep C Virus Infection-Related Cryoglobulinemia

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Epclusa (sofosbuvir/velpatasvir)Experimental Treatment1 Intervention
Epclusa is taken by mouth for 12 weeks as per the FDA label.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epclusa
2016
Completed Phase 3
~30

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,449 Previous Clinical Trials
4,332,017 Total Patients Enrolled
10 Trials studying Kidney Failure
10,720 Patients Enrolled for Kidney Failure
Gilead SciencesIndustry Sponsor
1,134 Previous Clinical Trials
867,509 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,081 Previous Clinical Trials
42,724,370 Total Patients Enrolled
1 Trials studying Kidney Failure
94,017 Patients Enrolled for Kidney Failure

Media Library

Kidney Failure Research Study Groups: Epclusa (sofosbuvir/velpatasvir)
~49 spots leftby May 2025
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