A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients

• Status: Recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The Transplanting Hepatitis C Kidneys into Negative KidnEy Recipients [THINKER-NEXT] study will include adult kidney transplant candidates without hepatitis C virus (HCV) infection on the transplant waiting list who will consent to kidney transplantation from a deceased donor infected with HCV, followed by treatment with a direct acting antiviral. The 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 (these patients are called Transplant Cohort). 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 (these patients are called Wait-list Cohort). Lastly, renal pathologic findings will be compared among HCV-viremic donors and HCV-negative comparator donors.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: Gilead Sciences; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Sofosbuvir-velpatasvir drug combination; Velpatasvir

Criteria

Inclusion Criteria:

• Able to provide informed consent

• Active waiting list status for isolated kidney transplant

• 18 to 70 years of age

• No living kidney donor

• Panel reactive antibody ≤97%

• Agreement for participation from patient's transplant nephrologist

Exclusion Criteria:

• Hepatocellular carcinoma

• Hepatitis B surface antigen and/or DNA positive

• HCV nucleic acid test (NAT) positive (an isolated positive HCV Ab is not an exclusion)

• HIV RNA-positive or HIV antibody positive

• Other chronic liver disease (excluding non-alcoholic fatty liver disease [NAFLD] with normal liver enzymes)

• Persistently elevated liver transaminases (defined as the upper limit of normal at the reference laboratory)

• Significant hepatic fibrosis on screening elastography (Fibroscan value ≥8kPa; equates to >F2 fibrosis on the Metavir staging system

• Primary Focal Segmental Glomerulosclerosis (FSGS), FSGS recurring in initial transplant, or other disease process at high risk of early graft failure per the treating transplant nephrologist

• Current use of amiodarone (due to interaction with sofosbuvir)

• Transplant candidate requires antibody desensitization protocol for transplantation

• Female who is pregnant, planning to become pregnant during the study, or breast-feeding

• Participation in another interventional study of any investigational agent or approved medication, or participation in another kind interventional study that the responsible investigator deems to be an exclusion from period 6 months prior to screening to last study visit