A Trial of Transplanting Hepatitis C Kidneys into Hepatitis C-Negative Kidney Recipients (THINKER-NEXT)

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Funding: NIDDK
Investigator: Reese, P; Schaubel, D; Goldberg, D

The CRCU serves as the Data Coordinating Center for the THINKER-NEXT trial. The THINKER-NEXT trial, led by Peter Reese, MD and Douglas Schaubel PhD at The Perelman School of Medicine and David Goldberg, MD at the University of Miami in Florida, is a single arm open-label NIDDK-funded clinical trial.  The main objective of the study is to estimate the hepatitis C virus (HCV) cure rate after transplantation, using kidneys from HCV-infected deceased donors for HCV-negative recipients, followed by treatment with direct acting antivirals. THINKER-NEXT will include adult kidney transplant candidates without HCV infection on the transplant waiting list who will consent to kidney transplantation from a deceased donor infected with HCV. Two hundred recipients of HCV-viremic kidneys will be treated with a direct acting antiviral. 

The THINKER-NEXT Trial launched in April 2021.  The trial expects to transplant 200 candidates over a period of 5 years at the following 9 sites: University of Pennsylvania; Johns Hopkins; Massachusetts General Hospital; New York Presbyterian Hospital-Columbia University; Jackson Memorial Hospital/University of Miami; Vanderbilt University; University of Cincinnati; Medical University of South Carolina, and University of Alabama at Birmingham.  The CRCU, under the leadership of Richard Landis, PhD., provides comprehensive project management and data management services to this multi-center trial.

THINKER-NEXT website https://www.thinkernextstudy.org/