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

Kidney Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04605679
• Other study ID #: 5200098
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 6, 2020
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 31
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure
• Renal Insufficiency

Intervention

Procedure:
• Kidney Transplantation
A HCV negative or previously successfully treated recipient with a HCV positive kidney graft

Locations

Country	Name	City	State
United States	Loma Linda University Health-Transplant Institute	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Durand CM, Bowring MG, Brown DM, Chattergoon MA, Massaccesi G, Bair N, Wesson R, Reyad A, Naqvi FF, Ostrander D, Sugarman J, Segev DL, Sulkowski M, Desai NM. Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus-Infected Donors to Noninfected Recipients: An Open-Label Nonrandomized Trial. Ann Intern Med. 2018 Apr 17;168(8):533-540. doi: 10.7326/M17-2871. Epub 2018 Mar 6. — View Citation

Reese PP, Abt PL, Blumberg EA, Van Deerlin VM, Bloom RD, Potluri VS, Levine M, Porrett P, Sawinski D, Nazarian SM, Naji A, Hasz R, Suplee L, Trofe-Clark J, Sicilia A, McCauley M, Gentile C, Smith J, Niknam BA, Bleicher M, Reddy KR, Goldberg DS. Twelve-Month Outcomes After Transplant of Hepatitis C-Infected Kidneys Into Uninfected Recipients: A Single-Group Trial. Ann Intern Med. 2018 Sep 4;169(5):273-281. doi: 10.7326/M18-0749. Epub 2018 Aug 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-year graft and patient survival	Will track subjects post transplant for 12 months	From the date of transplant through the last day of 12 month post transplant

External Links

•   Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus-Infected Donors to Noninfected Recipients
•   Twelve-Month Outcomes After Transplant of Hepatitis C-Infected Kidneys Into Uninfected Recipients