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Zepatier for Kidney Failure (THINKER Trial)

Phase 1 & 2
Waitlist Available
Led By Stacey Prenner, MD
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 52 weeks
Awards & highlights

THINKER Trial Summary

This trial is testing whether it's safe to transplant kidneys from donors with Hepatitis C into patients without it, who will then be treated for the virus.

Eligible Conditions
  • Kidney Failure

THINKER Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 52 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
Number of Subjects Cured
Number of Subjects With SAE Attributable to HCV Therapy

Side effects data

From 2018 Phase 4 trial • 10 Patients • NCT02781649
33%
Pulomonary infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Donor Genotype 2 or 3
Donor Genotype 1a no Resistance or 1b
Donor Genotype 1a With Resistance

THINKER Trial Design

1Treatment groups
Experimental Treatment
Group I: Direct-acting antiviral treatment for HCVExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mavyret
2018
Completed Phase 4
~110
Zepatier
2016
Completed Phase 4
~110

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,975 Total Patients Enrolled
2 Trials studying Kidney Failure
94,017 Patients Enrolled for Kidney Failure
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,080 Total Patients Enrolled
1 Trials studying Kidney Failure
8 Patients Enrolled for Kidney Failure
Stacey Prenner, MDPrincipal InvestigatorUniversity of Hospital of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Transplant InternationalJournal
Utilization of Hepatitis C Antibody-positive Livers: Genotype Dominance Is Virally Determined
O’Leary, Jacqueline G., Michael A. Neri, James F. Trotter, Gary L. Davis, and Göran B. Klintmalm. 2012. “Utilization of Hepatitis C Antibody-positive Livers: Genotype Dominance Is Virally Determined”. Transplant International. Frontiers Media SA. doi:10.1111/j.1432-2277.2012.01498.x.
Annals of Internal MedicineJournal
Twelve-month Outcomes After Transplant of Hepatitis C–infected Kidneys into Uninfected Recipients
Reese, Peter P., Peter L. Abt, Emily A. Blumberg, Vivianna M. Van Deerlin, Roy D. Bloom, Vishnu S. Potluri, Matthew Levine, et al.. 2018. “Twelve-month Outcomes After Transplant of Hepatitis C–infected Kidneys into Uninfected Recipients”. Annals of Internal Medicine. American College of Physicians. doi:10.7326/m18-0749.
The LancetJournal
Efficacy and Safety of 8 Weeks Versus 12 Weeks of Treatment with Grazoprevir (MK-5172) and Elbasvir (MK-8742) with or Without Ribavirin in Patients with Hepatitis C Virus Genotype 1 Mono-infection and Hiv/hepatitis C Virus Co-infection (C-WORTHY): A Randomised, Open-label Phase 2 Trial
Sulkowski, Mark, Christophe Hezode, Jan Gerstoft, John M Vierling, Josep Mallolas, Stanislas Pol, Marcelo Kugelmas, et al.. 2015. “Efficacy and Safety of 8 Weeks Versus 12 Weeks of Treatment with Grazoprevir (MK-5172) and Elbasvir (MK-8742) with or Without Ribavirin in Patients with Hepatitis C Virus Genotype 1 Mono-infection and Hiv/hepatitis C Virus Co-infection (C-WORTHY): A Randomised, Open-label Phase 2 Trial”. The Lancet. Elsevier BV. doi:10.1016/s0140-6736(14)61793-1.
Journal of HepatologyJournal
Grazoprevir and Elbasvir Plus Ribavirin for Chronic HCV Genotype-1 Infection After Failure of Combination Therapy Containing a Direct-acting Antiviral Agent
Forns, Xavier, Stuart C. Gordon, Eli Zuckerman, Eric Lawitz, Jose L. Calleja, Harald Hofer, Christopher Gilbert, et al.. 2015. “Grazoprevir and Elbasvir Plus Ribavirin for Chronic HCV Genotype-1 Infection After Failure of Combination Therapy Containing a Direct-acting Antiviral Agent”. Journal of Hepatology. Elsevier BV. doi:10.1016/j.jhep.2015.04.009.
~7 spots leftby May 2025
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