ESRDEarly Phase 1NCT04682509
A Single-center Pilot Study Evaluating a Preemptive Short Course of Glecaprevir/Pibrentasvir in Hepatitis C Positive to Negative Kidney Transplantation
A Early Phase 1 study testing Glecaprevir/pibrentasvir in people with ESRD, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the feasibility of a 2 week course of glecaprevir/pibrentasvir (Mavyret) starting immediately prior to transplantation to treat hepatitis C virus (HCV) in kidney transplant recipients who receive a kidney from a donor with HCV. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- ESRD
- What is being tested?
- Glecaprevir/pibrentasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Mar 2022to 28 Feb 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Listed for kidney transplantation at NYU Langone Health and willing to accept HCV positive donor organs
- Able to complete routine post-transplant visits and study visits for a minimum of 1 year after transplantation
- Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Stategy (REMS) after transplant due to increased risk of birth defects and/or miscarriage
- Both men and women must agree to use at least one barrier method of contraception after transplant to prevent any secretion exchange
- Able and willing to provide informed consent
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- Receive an organ offer for a kidney from a deceased donor that:
- Is HCV NAT positive
- Meets all standard criteria for organ acceptability at NYU Langone Transplant Institute
Who cannot join
- HCV RNA positive or history of previously treated HCV
- Evidence of active hepatitis B infection or on active antiviral treatment of HBV
- HIV positivity
- Pregnant or nursing (lactacting) women
- Current use of atazanavir or rifampin
- Known hypersensitivity to glecaprevir and/or pibrentasvir
Show all 13Show fewer
- Current or history of decompensated liver disease
- Recipients of dual organs (i.e. simultaneous liver and kidney transplant, simultaneous kidney and pancreas transplant, or simultaneous heart and kidney transplant)
- Receive an organ offer for a kidney from a deceased donor that is:
- Confirmed HIV positive
- Confirmed HBV positive (positive hepatitis B surface antigen, and/or detectable hepatitis B virus DNA)
- Known to have previously failed DAA therapy for treatment for HCV
- HCV antibody positive, but NAT negative
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this research study is to evaluate the feasibility of a 2 week course of glecaprevir/pibrentasvir (Mavyret) starting immediately prior to transplantation to treat hepatitis C virus (HCV) in kidney transplant recipients who receive a kidney from a donor with HCV.
Read the detailed description
This is a prospective, open-label, single-center, pilot study. The patient population will include 20 patients who are on the kidney transplant waitlist at NYU Langone Health, are hepatitis C virus (HCV) negative, are willing to accept an organ from an HCV positive donor, and consent to participate in this trial. Study subjects will receive a kidney transplant from a deceased donor who tested positive for HCV as confirmed by nucleic acid amplification testing (NAT) per standard of care. All study subjects will receive a two week course of preemptive therapy with glecaprevir/pibrentasvir (Mavyret®), starting on postoperative day (POD) 0 prior to the transplant. If HCV RNA is undetectable after 2 weeks of therapy, Mavyret will be discontinued and study subjects will be followed with an intensive HCV monitoring protocol. If HCV RNA is detectable after 2 weeks of therapy, Mavyret will be continued to complete a full course of 8 weeks per standard of care. All patients will undergo close monitoring and surveillance for HCV viremia post-transplant to ensure that sustained virologic response (SVR) is achieved.
- Conditions
- ESRD
- Being tested
- Glecaprevir/pibrentasvir
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glecaprevir/pibrentasvirDrug
Also called Mavyret
Manufacturer is AbbVie, Inc., North Chicago, IL Mavyret® is commercially available and FDA approved for the treatment of HCV genotype 1, 2, 3, 4, 5, or 6 infection in patients without cirrhosis or with compensated cirrhosis and also for the treatment of adult patients with HCV genotype 1 infection who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor. An immediate release bilayer oral tablet containing a fixed-dose combination of 100 mg of glecaprevir and 40 mg of pibrentasvir. The daily dose of glecaprevir/pibrentasvir used will be the standard FDA approved dose: 3 tablets taken once daily (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg).
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | All study subjects will receive glecaprevir/pibrentasvir (Mavyret®) 300/120 mg orally x 14 days, starting on POD 0 prior to transplantation of the HCV positive kidney. If HCV RNA is detectable after 2 weeks of therapy, Mavyret® will be continued to complete a full course of 8 weeks per standard of care. Safety monitoring and frequent surveillance for HCV viremia will occur for all subjects throughout the duration of the study. The kidney transplantation procedure and routine post-transplant management will be performed per standard of care. Receives: Drug: Glecaprevir/pibrentasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Percentage of Incidence of sustained clearance of HCV (cure) 12 weeks after treatment of viremia
Measured in percentage of patients with SVR after treatment for HCV after kidney transplant. SVR will be defined as the absence of detectable HCV RNA Quantitative (PCR) testing 12 weeks after the completion of the treatment course.
Measured: Visit 2 (Day 1) , Visit 3 (Day 3) , Visit 4 (Day 7), Visit 5 (Day 13), Visit 16 (Day 365)
Secondary outcomes (8)
Percentage of Overall patient and graft survival at 1 year post-transplant
Patients will have regular follow-up as standard-of-care for all kidney transplant recipients. Patients' survival will be readily apparent. Furthermore, all deaths of transplant recipients and allograft losses within the first year of transplant are required to be reported to UNOS. Survival rates will be reported as a percentage.
Measured: Visit 1 (Day 0), Visit 16 (Day 365)
Change in the Allograft function
This parameter is being used to measure overall graft function and will be described using the median value at 1 year post transplant for the cohort. All transplant recipients will have regular follow-up as standard-of-care and eGFR will be calculated using the MDRD equation.
Measured: Visit 1 (Day 0), Visit 16 (Day 365)
Percentage of Incidence and grade of biopsy-proven rejection
All transplant recipients will have regular follow-up as routine clinical care and as such, will receive for cause biopsies per standard of care if there is a clinical suspicion of rejection. Biopsies will be read by a renal pathologist per standard of care and reported in the EPIC system. The incidence of rejection will be calculated as a percentage of the patients with diagnosed rejection on biopsy within 1 year of transplant.
Measured: Visit 1 (Day 0), Visit 16 (Day 365)
Time course to transplantation (median)
Time to transplantation will be measured from the time of listing (recorded in EPIC) to time of transplant and also time from written acknowledgment of willingness to participate in the trial to time of transplant.
Measured: Screening vist, Visit 1 (Day 0)
Percentage of Incidence HCV viremia post-transplant and after 2 weeks of treatment
Measuring serial HCV RNA Quantitative (PCR) starting immediately after transplant and continued throughout the duration of the study. A patient will be considered to be viremic when a post-transplant HCV RNA Quantitative (PCR) test is positive. The incidence of viremia after transplant will be calculated as the percent of the patients transplanted with an HCV-positive donor who subsequently developed HCV viremia (detected by RNA Quantitative (PCR) testing). The incidence of viremia after two weeks of treatment will be calculated as the percentage of the patients with detectable HCV viremia (detected by RNA Quantitative (PCR) testing) after completing 2 weeks of treatment with glecaprevir/pibrentasvir and therefore require continuation of therapy to complete an 8 week course
Measured: Visit 1 (Day 0), Visit 5 (Day 13), Visit 16 (Day 365)
Time course of exposure to development of clinically detectable viremia in those who develop viremia
Measuring serial HCV RNA Quantitative (PCR) starting immediately after transplant and continued throughout the duration of the study to find the median time to viremia with standard deviations. If the HCV RNA Quantitative (PCR) test is positive at any time point, we will calculate the time from transplant to detectable HCV RNA Quantitative (PCR).
Measured: Visit 1 (Day 0) to Visit 16 (Days 364)
Time course of clearance of viremia after treatment initiation
Measuring serial HCV RNA Quantitative (PCR) starting immediately after transplant and continued throughout the duration of the study to find the median time to clearance with standard deviations. If the HCV RNA Quantitative (PCR) test is positive at any time point, we will calculate the time to documented clearance as indicated by an undetectable HCV RNA Quantitative (PCR),
Measured: Visit 1 (Day 0) to Visit 16 (Days 364)
Percentage of Incidence of treatment failure/treatment resistant strains of HCV
If SVR12 is not achieved with either a 2 week or 8 week course of glecaprevir/pibrentasvir, it will be considered a treatment failure and resistance testing will be performed. The incidence will be reported as a percentage.
Measured: Visit 1 (Day 0), Visit 5 (Day 13), Visit 9 (Day 56)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start20 Mar 2022
- Primary completion16 May 2023
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ESRDStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bonnie Lonze, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04682509
- Sponsor's protocol ID
- 20-01386
- Status last verified
- Jun 2024
- First submitted
- 22 Dec 2020
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: This is a single center pilot study. Data will be available once published.
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Pilot Study Evaluating a Preemptive Short Course of Glecaprevir/Pibrentasvir in Hepatitis C Positive to Negative Kidney Transplantation
- ClinicalTrials.gov ID
- NCT04682509
- Acronym / sponsor ID
- 20-01386
- Conditions
- ESRD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 20 Mar 2022 (actual)
- Primary completion
- 16 May 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 23 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the feasibility of a 2 week course of glecaprevir/pibrentasvir (Mavyret) starting immediately prior to transplantation to treat hepatitis C virus (HCV) in kidney transplant recipients who receive a kidney from a donor with HCV.
Detailed description
This is a prospective, open-label, single-center, pilot study. The patient population will include 20 patients who are on the kidney transplant waitlist at NYU Langone Health, are hepatitis C virus (HCV) negative, are willing to accept an organ from an HCV positive donor, and consent to participate in this trial. Study subjects will receive a kidney transplant from a deceased donor who tested positive for HCV as confirmed by nucleic acid amplification testing (NAT) per standard of care. All study subjects will receive a two week course of preemptive therapy with glecaprevir/pibrentasvir (Mavyret®), starting on postoperative day (POD) 0 prior to the transplant. If HCV RNA is undetectable after 2 weeks of therapy, Mavyret will be discontinued and study subjects will be followed with an intensive HCV monitoring protocol. If HCV RNA is detectable after 2 weeks of therapy, Mavyret will be continued to complete a full course of 8 weeks per standard of care. All patients will undergo close monitoring and surveillance for HCV viremia post-transplant to ensure that sustained virologic response (SVR) is achieved.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Drug: Glecaprevir/pibrentasvirAll study subjects will receive glecaprevir/pibrentasvir (Mavyret®) 300/120 mg orally x 14 days, starting on POD 0 prior to transplantation of the HCV positive kidney. If HCV RNA is detectable after 2 weeks of therapy, Mavyret® will be continued to complete a full course of 8 weeks per standard of care. Safety monitoring and frequent surveillance for HCV viremia will occur for all subjects throughout the duration of the study. The kidney transplantation procedure and routine post-transplant management will be performed per standard of care. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years of age
- Listed for kidney transplantation at NYU Langone Health and willing to accept HCV positive donor organs
- Able to complete routine post-transplant visits and study visits for a minimum of 1 year after transplantation
- Women of childbearing potential must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Stategy (REMS) after transplant due to increased risk of birth defects and/or miscarriage
- Both men and women must agree to use at least one barrier method of contraception after transplant to prevent any secretion exchange
Key exclusion criteria (13 listed)
- HCV RNA positive or history of previously treated HCV
- Evidence of active hepatitis B infection or on active antiviral treatment of HBV
- HIV positivity
- Pregnant or nursing (lactacting) women
- Current use of atazanavir or rifampin
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/pibrentasvirAlso: MavyretManufacturer is AbbVie, Inc., North Chicago, IL Mavyret® is commercially available and FDA approved for the treatment of HCV genotype 1, 2, 3, 4, 5, or 6 infection in patients without cirrhosis or with compensated cirrhosis and also for the treatment of adult patients with HCV genotype 1 infection who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor. An immediate release bilayer oral tablet containing a fixed-dose combination of 100 mg of glecaprevir and 40 mg of pibrentasvir. The daily dose of glecaprevir/pibrentasvir used will be the standard FDA approved dose: 3 tablets taken once daily (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg). | Drug | Study group |
Primary outcome
Change in the Percentage of Incidence of sustained clearance of HCV (cure) 12 weeks after treatment of viremia
Time frame: Visit 2 (Day 1) , Visit 3 (Day 3) , Visit 4 (Day 7), Visit 5 (Day 13), Visit 16 (Day 365)
Measured in percentage of patients with SVR after treatment for HCV after kidney transplant. SVR will be defined as the absence of detectable HCV RNA Quantitative (PCR) testing 12 weeks after the completion of the treatment course.
8 secondary outcomes
Percentage of Overall patient and graft survival at 1 year post-transplant
Time frame: Visit 1 (Day 0), Visit 16 (Day 365)
Change in the Allograft function
Time frame: Visit 1 (Day 0), Visit 16 (Day 365)
Percentage of Incidence and grade of biopsy-proven rejection
Time frame: Visit 1 (Day 0), Visit 16 (Day 365)
Time course to transplantation (median)
Time frame: Screening vist, Visit 1 (Day 0)
Percentage of Incidence HCV viremia post-transplant and after 2 weeks of treatment
Time frame: Visit 1 (Day 0), Visit 5 (Day 13), Visit 16 (Day 365)
Time course of exposure to development of clinically detectable viremia in those who develop viremia
Time frame: Visit 1 (Day 0) to Visit 16 (Days 364)
Time course of clearance of viremia after treatment initiation
Time frame: Visit 1 (Day 0) to Visit 16 (Days 364)
Percentage of Incidence of treatment failure/treatment resistant strains of HCV
Time frame: Visit 1 (Day 0), Visit 5 (Day 13), Visit 9 (Day 56)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Individual participant dataSharing planned: No. This is a single center pilot study. Data will be available once published.
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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.
Bonnie Lonze, MD, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Glecaprevir/pibrentasvir in people with ESRD, run by NYU Langone Health at 1 site 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?
The sponsor lists 9 inclusion and 13 exclusion criteria. 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 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in the Percentage of Incidence of sustained clearance of HCV (cure) 12 weeks after treatment of viremia (time frame: Visit 2 (Day 1) , Visit 3 (Day 3) , Visit 4 (Day 7), Visit 5 (Day 13), Visit 16 (Day 365)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2024.