Clinical trial NCT03781726: Multi-center Study to Transplant Hepatitis-C Infected Kidneys
Official title: A Multi-Center, Open-Label Study of Glecaprevir/Pibrentasvir to Treat Recipients of Transplanted Kidneys From Deceased Donors With Hepatitis C Virus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Renal Failure Chronic
Hepatitis C
Keywords: hemodialysis
renal failure
kidney transplant
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: AbbVie
name: University of Pennsylvania
name: Johns Hopkins University
name: University of Cincinnati
name: Weill Medical College of Cornell University
name: University of Michigan
name: Northwestern University
First posted: 2018-12-20
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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.

Eligibility criteria: Recipient 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

Primary outcomes:
measure: Number of Participants With Undetectable HCV
timeFrame: 12 weeks post treatment
Secondary outcomes:
measure: Percentage of Subjects With On-treatment Virologic Failure
timeFrame: During 8 week treatment course
measure: Percentage of Subjects With Post-treatment Virologic Relapse
timeFrame: During 12 week post treatment follow-up
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Baltimore
country: United States
facility: John Hopkins
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: New York
country: United States
facility: Weill Cornell Medical Center
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Massachusetts General Hospital
name: Raymond T Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sise ME, Goldberg DS, Schaubel DE, Fontana RJ, Kort JJ, Alloway RR, Durand CM, Blumberg EA, Woodle ES, Sherman KE, Brown RS Jr, Friedewald JJ, Desai NM, Sultan ST, Levitsky J, Lee MD, Strohbehn IA, Landis JR, Fernando M, Gustafson JL, Chung RT, Reese PP. One-Year Outcomes of the Multi-Center StudY to Transplant Hepatitis C-InfeCted kidneys (MYTHIC) Trial. Kidney Int Rep. 2021 Dec 1;7(2):241-250. doi: 10.1016/j.ekir.2021.11.022. eCollection 2022 Feb.