Kidney FailurePhase 4NCT03623568
Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant
A Phase 4 study testing glecaprevir/pibrentasvir tablets in people with Kidney Failure and Kidney Diseases, run by Raymond T. Chung, MD at 1 site in United States.
Trial summary
This is a proof of concept, single center study for the donation of HCV-positive kidney to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Kidney Failure, Kidney Diseases, Hepatitis C
- What is being tested?
- glecaprevir/pibrentasvir tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2019to 15 Apr 2021
- Phase
- Phase 4
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Met MGH transplant center criteria and already listed for kidney transplant
- No available living kidney donor
- Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤ 1095 days of accrued transplant waiting time if blood type B or O.
- On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate <15mL/min/1.73m2 at the time of screening
- Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method
- Weigh at least 50kg
- Serum ALT within normal limits with no history of liver disease
- Able to sign informed consent
Who cannot join
- AB blood type
- BMI > 35
- Any liver disease in recipient
- Pregnant or nursing (lactating) women
- Known allergy or intolerance to tacrolimus that would require administration of cyclosporine rather than tacrolimus given the known drug-drug interaction between cyclosporine and Mavyret
- Cardiomyopathy (LV ejection fraction < 50%)
Show all 15Show fewer
- Albumin < 3g/dl or platelet count < 75 x 103/mL
- Positive donor specific antibodies or positive cross match deemed to be clinically relevant and increasing risk of rejection per the transplant surgeon or nephrologist
- Positive donor specific antibodies or positive cross match deemed to be clinically relevant and increasing risk of rejection per the transplant surgeon or nephrologist
- HCV RNA positive
- Hepatitis B surface antigen positive
- Any known liver disease or elevated liver transaminases
- Patients with primary focal segmental glomerulosclerosis (FSGS), FSGS recurring after previous transplant, or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or the investigator team
- Any contra-indication to kidney transplantation per MGH center protocol
- Patients on the following medications who cannot stop therapy: carbamazepine, rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant
This is a proof of concept, single center study for the donation of HCV-positive kidney to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.
Read the detailed description
The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after kidney transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCV positive donor kidney to an HCV naïve recipient.
- Conditions
- Kidney Failure, Kidney Diseases, Hepatitis C
- Being tested
- glecaprevir/pibrentasvir tablets
- Keywords
- CKD, HCV, Hepatitis C, Transplant
- Medical subject headings
- Renal Insufficiency, Kidney Diseases, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glecaprevir/pibrentasvir tabletsDrug
Also called Mavyret
12 weeks of treatment with Mavyret
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Mavyret (glecaprevir/pibrentasvir) for HCV | Experimental | 12 weeks of treatment with Mavyret Receives: Drug: glecaprevir/pibrentasvir tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable HCV RNA in blood
Negative HCV viral RNA at 12 weeks after the last dose of treatment as determined by blood test
Measured: 12 weeks post treatment
Secondary outcomes (2)
Safety (based on number of adverse events and out of range lab values) of DAA therapy in patients undergoing kidney transplantation)
Safety of Mavyret therapy in the kidney transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating out of range laboratory results as compared to baseline/pretreatment values per patient.
Measured: 12 weeks post treatment
Tolerability (based on number of adverse events and out of range lab values) of DAA therapy in patients undergoing kidney transplantation
Tolerability of Mavyret therapy in the kidney transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating out of range laboratory results as compared to baseline/pretreatment values per patient.
Measured: 12 Weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start15 Feb 2019 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion15 Apr 2021 (estimated)
Why it stopped: did not move forward with IRB approval, competing study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Raymond T. Chung, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Raymond T. Chung, MD, Massachusetts General Hospital
- Investigators
- Raymond T Chung, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623568
- Sponsor's protocol ID
- 2018P001077
- Status last verified
- May 2019
- First submitted
- 2 Aug 2018
- Last updated
- 3 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anticipate to share coded data with collaborators
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant
- ClinicalTrials.gov ID
- NCT03623568
- Acronym / sponsor ID
- 2018P001077
- Conditions
- Kidney Failure, Kidney Diseases, Hepatitis C
- Keywords
- CKD, HCV, Hepatitis C, Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: did not move forward with IRB approval, competing study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Raymond T. Chung, MDUniversity, hospital or other
- Study start
- 15 Feb 2019 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 15 Apr 2021 (estimated)
- First posted
- 9 Aug 2018 (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.
This is a proof of concept, single center study for the donation of HCV-positive kidney to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.
Detailed description
The goal of this study is to determine if preoperative dosing and sustained administration of pan-genotypic DAA therapy after kidney transplantation prevents the transmission of hepatitis C virus (HCV) infection from an HCV positive donor kidney to an HCV naïve recipient.
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 Mavyret (glecaprevir/pibrentasvir) for HCV | Experimental | Drug: glecaprevir/pibrentasvir tablets12 weeks of treatment with Mavyret |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Met MGH transplant center criteria and already listed for kidney transplant
- No available living kidney donor
- Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤ 1095 days of accrued transplant waiting time if blood type B or O.
- On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate <15mL/min/1.73m2 at the time of screening
- Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method
Key exclusion criteria (15 listed)
- AB blood type
- BMI > 35
- Any liver disease in recipient
- Pregnant or nursing (lactating) women
- Known allergy or intolerance to tacrolimus that would require administration of cyclosporine rather than tacrolimus given the known drug-drug interaction between cyclosporine and Mavyret
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 tabletsAlso: Mavyret12 weeks of treatment with Mavyret | Drug | Treatment with Mavyret (glecaprevir/pibrentasvir) for HCV |
Primary outcome
Undetectable HCV RNA in blood
Time frame: 12 weeks post treatment
Negative HCV viral RNA at 12 weeks after the last dose of treatment as determined by blood test
2 secondary outcomes
Safety (based on number of adverse events and out of range lab values) of DAA therapy in patients undergoing kidney transplantation)
Time frame: 12 weeks post treatment
Tolerability (based on number of adverse events and out of range lab values) of DAA therapy in patients undergoing kidney transplantation
Time frame: 12 Weeks post treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2019.
- Individual participant dataSharing planned: Yes. Anticipate to share coded data with collaborators
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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
1 site 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 tablets in people with Kidney Failure and Kidney Diseases, run by Raymond T. Chung, MD 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 8 inclusion and 15 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: withdrawn, as of the sponsor's last update on 3 Jun 2019. 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?
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Undetectable HCV RNA in blood (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?
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 3 Jun 2019.