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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04605679
Other study ID # 5200098
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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