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Multi-center Study to Transplant Hepatitis-C Infected Kidneys (MYTHIC)

Primary Purpose

Renal Failure Chronic, Hepatitis C

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
glecaprevir/pibrentasvir treatment
Sponsored by
Raymond Chung
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Failure Chronic focused on measuring hemodialysis, renal failure, kidney transplant

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern Medicine
  • John Hopkins
  • Massachusetts General Hospital
  • University of Michigan
  • Weill Cornell Medical Center
  • University of Cincinnati Medical Center
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with glecaprevir/pibrentasvir Fixed Dose Combination

Arm Description

8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir

Outcomes

Primary Outcome Measures

Number of Participants With Undetectable HCV
HCV RNA < LLOQ 12 weeks after the last actual dose of G/P

Secondary Outcome Measures

Percentage of Subjects With On-treatment Virologic Failure
HCV RNA > LLOQ during G/P treatment
Percentage of Subjects With Post-treatment Virologic Relapse
HCV RNA > LLOQ after completion of G/P treatment and prior HCV RNA < LLOQ while on treatment

Full Information

First Posted
December 18, 2018
Last Updated
January 18, 2022
Sponsor
Raymond Chung
Collaborators
AbbVie, University of Pennsylvania, Johns Hopkins University, University of Cincinnati, Weill Medical College of Cornell University, University of Michigan, Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT03781726
Brief Title
Multi-center Study to Transplant Hepatitis-C Infected Kidneys
Acronym
MYTHIC
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2019 (Actual)
Primary Completion Date
March 20, 2020 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Raymond Chung
Collaborators
AbbVie, University of Pennsylvania, Johns Hopkins University, University of Cincinnati, Weill Medical College of Cornell University, University of Michigan, Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure Chronic, Hepatitis C
Keywords
hemodialysis, renal failure, kidney transplant

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment with glecaprevir/pibrentasvir Fixed Dose Combination
Arm Type
Experimental
Arm Description
8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir
Intervention Type
Drug
Intervention Name(s)
glecaprevir/pibrentasvir treatment
Other Intervention Name(s)
Mavyret treatment
Intervention Description
combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
Primary Outcome Measure Information:
Title
Number of Participants With Undetectable HCV
Description
HCV RNA < LLOQ 12 weeks after the last actual dose of G/P
Time Frame
12 weeks post treatment
Secondary Outcome Measure Information:
Title
Percentage of Subjects With On-treatment Virologic Failure
Description
HCV RNA > LLOQ during G/P treatment
Time Frame
During 8 week treatment course
Title
Percentage of Subjects With Post-treatment Virologic Relapse
Description
HCV RNA > LLOQ after completion of G/P treatment and prior HCV RNA < LLOQ while on treatment
Time Frame
During 12 week post treatment follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond T Chung, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
John Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Coded data is anticipated to be shared with collaborators in this multi-center consortium
IPD Sharing Time Frame
Real time
IPD Sharing Access Criteria
researchers accessing IPD must be an approved site within the consortium.
Citations:
PubMed Identifier
35155863
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.
Results Reference
derived

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Multi-center Study to Transplant Hepatitis-C Infected Kidneys

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