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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 weeks
Awards & highlights

THINKER-NEXT Trial 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.Check my eligibility
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.See study design
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.

THINKER-NEXT Trial Eligibility Criteria

Inclusion Criteria

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

THINKER-NEXT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

THINKER-NEXT 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
2,359 Previous Clinical Trials
4,315,053 Total Patients Enrolled
10 Trials studying Kidney Failure
10,720 Patients Enrolled for Kidney Failure
Gilead SciencesIndustry Sponsor
1,084 Previous Clinical Trials
848,029 Total Patients Enrolled
University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,881,759 Total Patients Enrolled
2 Trials studying Kidney Failure
94,017 Patients Enrolled for Kidney Failure

Media Library

Kidney Failure Research Study Groups: Epclusa (sofosbuvir/velpatasvir)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are volunteers being taken on for this experiment at present?

"Affirmative. According to the clinicaltrials.gov database, this research project has been available for applications since June 22nd 2021 and was recently updated on September 26th 2022. 400 participants are needed across 9 sites of recruitment."

Answered by AI

To what extent have participants signed up for this research endeavor?

"Gilead Sciences, the sponsor of this medical trial, needs 400 suitable patients to carry out their research. The study will be conducted at Johns Hopkins in Baltimore and Medical University of South carolina in Charleston."

Answered by AI

Has Epclusa been subjected to any other research studies in the past?

"In 2016, the first clinical trials of Epclusa were conducted at AOU Città della Salute e della Scienza di Torino. Subsequently, 241 studies have been completed and 27 more are ongoing as we speak; many of them based in Baltimore, Maryland."

Answered by AI

Are there any institutions in North America presently conducting this trial?

"This clinical trial is accepting participants from 9 different sites, including Baltimore, Charleston and Saint Louis. To reduce the need for travel, it's beneficial to pick a location close to you when enrolling."

Answered by AI

Has the Food and Drug Administration sanctioned Epclusa for public use?

"The safety of Epclusa has been provisionally rated a 2 due to the presence of data confirming its security, though efficacy remains untested in clinical trials."

Answered by AI

Does this research include participants older than 30 years of age?

"This trial's enrolment qualifications require that participants be aged between 18 and 70 years old. Conversely, there are 41 medical studies designed for minors and 431 trials especially geared towards seniors."

Answered by AI

Do my qualifications meet the criteria for this research program?

"The current trial is seeking to enrol 400 individuals suffering from chronic kidney failure, within the age range of 18-70. Candidates must meet certain requirements such as being above legal adulthood and consenting to participate in the study. In addition, they need an active status on a waiting list for isolated kidney transplantation with a Panel Reactive Antibody (PRA) ≤97%, unless there are multiple moderate level HLA antibodies present that would yield calculated PRA greater than 50% - then other eligibility criteria apply too."

Answered by AI

Who else is applying?

What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I'm looking for some help with my kidneys.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients
2021. "A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04075916.
All > Autoimmune Hepatitis > Hepatitis C
~117 spots leftby May 2025
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