Renal Failure ChronicPhase 4NCT03093740
Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant
A Phase 4 study testing Zepatier and Zepatier plus Sofosbuvir in people with Renal Failure Chronic and Hepatitis C, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Open label single 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 40 to 70 years
- Conditions the study is for
- Renal Failure Chronic, Hepatitis C
- What is being tested?
- Zepatier and Zepatier plus Sofosbuvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 31 Jan 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Donor meets MGH transplant center criteria and already listed for isolated kidney transplant
- No available living kidney donor
- Recipient has ≤ 730 days of accrued transplant waiting time
- Recipient chronic hemodialysis or peritoneal dialysis
- Recipient must agree to birth control.
- °.Weigh ≥ 50kg
- Serum ALT within normal limits
- Subject's Insurance company approves payment for DAA therapy post-kidney transplant
Who cannot join
- AB Blood type
- HCV genotype 1
- BMI > 35
- Any liver disease in recipient
- Pregnant or nursing (lactating) women
- Known allergy or intolerance to tacrolimus that would require administration of cyclosporine
Show all 13Show fewer
- Albumin < 3g/dl or
- Platelet count < 75 x 103/mL
- Positive crossmatch or positive donor specific antibodies
- HCV RNA positive
- Hepatitis B surface antigen positive
- Patients with primary focal segmental glomerulosclerosis (FSGS)
- Any contra-indication to kidney transplantation per our center protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient
Open label single 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 direct acting antivirals for 12-16 weeks after kidney transplantation prevents 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
- Zepatier, Zepatier plus Sofosbuvir
- 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.
ZepatierDrug
Based on negative viral resistance testing of the donor treatment will be Zepatier
Zepatier plus SofosbuvirDrug
Based on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir
| Study group | Role | What they receive |
|---|---|---|
| HCV treatment - no viral resistance | Experimental | Based on the genotype and negative viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier Receives: Drug: Zepatier |
| HCV treatment - viral resistance | Experimental | Based on the genotype and positive viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier plus Sofosbuvir Receives: Drug: Zepatier plus Sofosbuvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable HCV RNA
Negative HCV viral load 12 weeks after last dose of treatment
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 posted28 Mar 2017
- Study start1 Oct 2018 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jan 2021 (estimated)
Why it stopped: Withdrew IRB application, never approved and no subjects enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Failure ChronicStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Based on the genotype and viral resistance testing of the donor, that will be determined within the first week, we will initiate a genotype specific regimen for HCV treatment as available by prescription
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raymond T. Chung, MD, Massachusetts General Hospital
- Investigators
- Raymond Chung, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093740
- Sponsor's protocol ID
- 2017P000301
- Status last verified
- Dec 2018
- First submitted
- 22 Mar 2017
- Last updated
- 20 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: No current plans to share participant data
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient
- ClinicalTrials.gov ID
- NCT03093740
- Acronym / sponsor ID
- 2017P000301
- Conditions
- Renal Failure Chronic, Hepatitis C
- Keywords
- hemodialysis, renal failure, kidney transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrew IRB application, never approved and no subjects enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jan 2021 (estimated)
- First posted
- 28 Mar 2017 (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.
Open label single 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 direct acting antivirals for 12-16 weeks after kidney transplantation prevents 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Based on the genotype and viral resistance testing of the donor, that will be determined within the first week, we will initiate a genotype specific regimen for HCV treatment as available by prescription
| Arm | Type | Receives |
|---|---|---|
| HCV treatment - no viral resistance | Experimental | Drug: ZepatierBased on the genotype and negative viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier |
| HCV treatment - viral resistance | Experimental | Drug: Zepatier plus SofosbuvirBased on the genotype and positive viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier plus Sofosbuvir |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Donor meets MGH transplant center criteria and already listed for isolated kidney transplant
- No available living kidney donor
- Recipient has ≤ 730 days of accrued transplant waiting time
- Recipient chronic hemodialysis or peritoneal dialysis
- Recipient must agree to birth control.
Key exclusion criteria (13 listed)
- AB Blood type
- HCV genotype 1
- BMI > 35
- Any liver disease in recipient
- Pregnant or nursing (lactating) women
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 |
|---|---|---|
| ZepatierBased on negative viral resistance testing of the donor treatment will be Zepatier | Drug | HCV treatment - no viral resistance |
| Zepatier plus SofosbuvirBased on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir | Drug | HCV treatment - viral resistance |
Primary outcome
Undetectable HCV RNA
Time frame: 12 weeks post treatment
Negative HCV viral load 12 weeks after last dose of 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 20 Dec 2018.
- Individual participant dataSharing planned: No. No current plans to share participant data
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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 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 Zepatier and Zepatier plus Sofosbuvir in people with Renal Failure Chronic and Hepatitis C, run by Massachusetts General Hospital 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 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: withdrawn, as of the sponsor's last update on 20 Dec 2018. 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 (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 20 Dec 2018.