Renal Failure ChronicPhase 4MYTHICNCT03781726
Multi-center Study to Transplant Hepatitis-C Infected Kidneys
A Phase 4 study testing glecaprevir/pibrentasvir treatment in people with Renal Failure Chronic and Hepatitis C, run by Raymond Chung at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Renal Failure Chronic, Hepatitis C
- What is being tested?
- glecaprevir/pibrentasvir treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesUnited States
- Study dates
- 10 Apr 2019to 31 Dec 2021
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Michigan
Ann Arbor, Michigan, 48109
John Hopkins
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern Medicine
Chicago, Illinois, 60611
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Weill Cornell Medical Center
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Multi-Center, Open-Label Study of Glecaprevir/Pibrentasvir to Treat Recipients of Transplanted Kidneys From Deceased Donors With Hepatitis C Virus
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.
Read the 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.
- Conditions
- Renal Failure Chronic, Hepatitis C
- Being tested
- glecaprevir/pibrentasvir treatment
- Keywords
- hemodialysis, renal failure, kidney transplant
- Medical subject headings
- Renal Insufficiency, Chronic, Hepatitis C, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glecaprevir/pibrentasvir treatmentDrug
Also called Mavyret treatment
combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with glecaprevir/pibrentasvir Fixed Dose Combination | Experimental | 8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir Receives: Drug: glecaprevir/pibrentasvir treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Undetectable HCV
HCV RNA < LLOQ 12 weeks after the last actual dose of G/P
Measured: 12 weeks post treatment
Secondary outcomes (2)
Percentage of Subjects With On-treatment Virologic Failure
HCV RNA > LLOQ during G/P treatment
Measured: During 8 week treatment course
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
Measured: During 12 week post treatment follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start10 Apr 2019
- Primary completion20 Mar 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Failure ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raymond Chung
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie, University of Pennsylvania, Johns Hopkins University, University of Cincinnati, Weill Medical College of Cornell University, University of Michigan, Northwestern University
- Responsible party
- Sponsor-investigator, Raymond Chung, Massachusetts General Hospital
- Investigators
- Raymond T Chung, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03781726
- Sponsor's protocol ID
- 2018P003140
- Acronym
- MYTHIC
- Status last verified
- Jan 2022
- First submitted
- 18 Dec 2018
- Last updated
- 26 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Coded data is anticipated to be shared with collaborators in this multi-center consortium
Publications
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.
PubMed 35155863
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Open-Label Study of Glecaprevir/Pibrentasvir to Treat Recipients of Transplanted Kidneys From Deceased Donors With Hepatitis C Virus
- ClinicalTrials.gov ID
- NCT03781726
- Acronym / sponsor ID
- MYTHIC / 2018P003140
- Conditions
- Renal Failure Chronic, Hepatitis C
- Keywords
- hemodialysis, renal failure, kidney transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Raymond ChungUniversity, hospital or other
- Collaborators
- AbbVie, University of Pennsylvania, Johns Hopkins University, University of Cincinnati, Weill Medical College of Cornell University, University of Michigan, Northwestern University
- Study start
- 10 Apr 2019 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Posted 11 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with glecaprevir/pibrentasvir Fixed Dose Combination | Experimental | Drug: glecaprevir/pibrentasvir treatment8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glecaprevir/pibrentasvir treatmentAlso: Mavyret treatmentcombination treatment with glecaprevir and pibrentasvir fixed dose tablet. | Drug | Treatment with glecaprevir/pibrentasvir Fixed Dose Combination |
Primary outcome
Number of Participants With Undetectable HCV
Time frame: 12 weeks post treatment
HCV RNA < LLOQ 12 weeks after the last actual dose of G/P
2 secondary outcomes
Percentage of Subjects With On-treatment Virologic Failure
Time frame: During 8 week treatment course
Percentage of Subjects With Post-treatment Virologic Relapse
Time frame: During 12 week post treatment follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35155863Sise 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.
- Individual participant dataSharing planned: Yes. Coded data is anticipated to be shared with collaborators in this multi-center consortium
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond T Chung, MD principal investigator
Massachusetts General Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing glecaprevir/pibrentasvir treatment in people with Renal Failure Chronic and Hepatitis C, run by Raymond Chung at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Undetectable HCV (time frame: 12 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03781726, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.