Multi-center Study to Transplant Hepatitis-C Infected Kidneys
NCT ID: NCT03781726
Last Updated: 2022-01-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
30 participants
INTERVENTIONAL
2019-04-10
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Treatment with glecaprevir/pibrentasvir Fixed Dose Combination
8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir
glecaprevir/pibrentasvir treatment
combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
Interventions
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glecaprevir/pibrentasvir treatment
combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Deceased donor organ with kidney donor profile index (KDPI) ≤0.85
* HCV RNA-positive
Exclusion Criteria
* 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
* Known prior HCV treatment with direct acting antiviral medication
* HIV RNA-positive
* HBV Surface antigen-positive or HBV DNA-positive
21 Years
65 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
University of Pennsylvania
OTHER
Johns Hopkins University
OTHER
University of Cincinnati
OTHER
Weill Medical College of Cornell University
OTHER
University of Michigan
OTHER
Northwestern University
OTHER
Raymond Chung
OTHER
Responsible Party
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Raymond Chung
Director of Hepatology
Principal Investigators
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Raymond T Chung, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Northwestern Medicine
Chicago, Illinois, United States
John Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Weill Cornell Medical Center
New York, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018P003140
Identifier Type: -
Identifier Source: org_study_id
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