Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04605679

Hepatitis C Virus (HCV) Positive Kidney Grafts in HCV Negative Recipients

To determine the efficacy and safety of transplanting HCV positive kidney allografts to HCV sero-negative patients who are on the waiting list.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Kidney Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Health-Transplant Institute

Loma Linda, California, 92354, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female
  • Age 18 and older
  • English and Spanish speaking patients
  • Active on the waiting list for kidney transplantation
  • Donor organ with Antibody and NAT (nucleic acid test) positive for HCV
  • HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
  • Willing and able to provide written informed consent

Exclusion criteria

  • Participants co-infected with HIV
  • Donor previously treated with an NS5a containing regimen (if treatment history of donor known)
  • Known allergies or hypersensitivity to DAA or RBV
  • Pregnancy and/or actively breastfeeding

Treatment and study plan

Kidney transplantation

Procedure

A HCV negative or previously successfully treated recipient with a HCV positive kidney graft

Primary outcomes

  1. 1-year graft and patient survival

    Time frame: From the date of transplant through the last day of 12 month post transplant

    Will track subjects post transplant for 12 months

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Official study title

Transplantation of HCV Donor Kidneys in HCV Negative or Previously Successfully Treated Recipients

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Oct 28, 2020
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.