Purpose

Open label multi center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.

Conditions

Eligibility

Eligible Ages
Between 21 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Estimated glomerular filtration rate(eGFR) < 15 ml/min/1.73 m2 - Listed for an isolated kidney transplantation - Able to understand and adhere to the study visit schedule and all other protocol requirements, and must voluntarily sign and date an informed consent - No available medically acceptable, compatible living kidney donor - Subject must agree to use an effective method of birth control per protocol specifications Recipient

Exclusion Criteria

  • History of severe, life-threatening or other significant sensitivity to immunosuppressants utilized in kidney transplant - Female who is pregnant, breastfeeding, or is planning to become pregnant during the course of the study - History of HIV - HCV RNA positive - HBV surface Ag-positive or detectable HBV DNA - Primary focal segmental glomerulosclerosis (FSGS) or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or investigator team - Presence of clinically significant liver disease - Transplant candidate requiring antibody desensitization protocol for transplantation - Most recent calculated panel reactive antibody (cPRA) >80%. - Prior recipient of a non-renal solid organ transplant Donor Organ Inclusion Criteria - Deceased donor organ with kidney donor profile index (KDPI) ≤0.85 - HCV RNA-positive Donor Organ Exclusion Criteria - Known prior HCV treatment with direct acting antiviral medication - HIV RNA-positive - HBV Surface antigen-positive or HBV DNA-positive

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Prevention
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment with glecaprevir/pibrentasvir Fixed Dose Combination
8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir
  • Drug: glecaprevir/pibrentasvir treatment
    combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
    Other names:
    • Mavyret treatment

More Details

Status
Completed
Sponsor
Raymond Chung

Study Contact

Detailed Description

The study objective is to determine if the administration of the direct acting antiviral glecaprevir/pibrentasvir for 8 weeks after kidney transplantation is both safe and effective at preventing the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.