Kidney FailurePhase 4NCT04320290
HCV + to HCV - Kidney Transplant
A Phase 4 study testing Direct Acting Antivirals in people with Kidney Failure and Hepatitis C, run by Massachusetts General Hospital.
Trial summary
This is a single center study characterizing the experience of administration of 8 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Hepatitis C
- What is being tested?
- Direct Acting Antivirals
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2020to 16 Jun 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Recipient Inclusion Criteria:
- Met MGH transplant center criteria and already listed for kidney transplant
- 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
- No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team
- Able to sign informed consent
Recipient Exclusion Criteria:
- Pregnant or nursing (lactating) women
- HBV positivity (Ag or DNA)
- Any contra-indication to kidney transplantation per center protocol
Donor Inclusion Criteria
- Detectable HCV NAT test
- KDPI score is less than ≤ 0.850
- Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation
Donor Exclusion Criteria
- Confirmed HIV
- Confirmed HBV positive (surface antigen or HBV DNA positive)
- Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)
About this study
Official title: Hepatitis C Viral Kidneys Used for Non-Viremic Recipients
This is a single center study characterizing the experience of administration of 8 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.
Read the detailed description
The goal of this study is to determine if 8 weeks of preemptive and sustained administration of pan-genotypic DAA therapy after kidney transplant prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor kidney to an HCV-naive recipient.
- Conditions
- Kidney Failure, Hepatitis C
- Being tested
- Direct Acting Antivirals
- Keywords
- Kidney Transplant, Kidney Failure, HCV, Hepatitis C
- Medical subject headings
- Renal Insufficiency, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Acting AntiviralsDrug
Also called Direct Acting Antiviral HCV Treatment
8 weeks of DAA treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Direct Acting Antiviral for HCV | Experimental | 8 weeks of treatment with HCV Direct Acting Antiviral tablet Receives: Drug: Direct Acting Antivirals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Undetectable HCV RNA
Negative HCV RNA 12 weeks after last dose of treatment
Measured: 12 weeks post-treatment
Rate of Serious and non-serious adverse events
Determine safety of HCV+ to HCV- kidney transplantation by determining rate of adverse events related to HCV viremia or DAA treatment
Measured: 1 year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start21 May 2020
- Primary completion16 Jun 2020
- Study completion16 Jun 2020
Why it stopped: New Related Protocol to be submitted
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.
- 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
- Not applicable
- Intervention model
- Single group
- 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, Nahel Elias, M.D., Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04320290
- Sponsor's protocol ID
- 2020P000374
- Status last verified
- Aug 2022
- First submitted
- 23 Mar 2020
- Last updated
- 31 Aug 2022
- 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 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatitis C Viral Kidneys Used for Non-Viremic Recipients
- ClinicalTrials.gov ID
- NCT04320290
- Acronym / sponsor ID
- 2020P000374
- Conditions
- Kidney Failure, Hepatitis C
- Keywords
- Kidney Transplant, Kidney Failure, HCV, Hepatitis C
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: New Related Protocol to be submitted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 21 May 2020 (actual)
- Primary completion
- 16 Jun 2020 (actual)
- Study completion
- 16 Jun 2020 (actual)
- First posted
- 24 Mar 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.
This is a single center study characterizing the experience of administration of 8 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.
Detailed description
The goal of this study is to determine if 8 weeks of preemptive and sustained administration of pan-genotypic DAA therapy after kidney transplant prevents the transmission of hepatitis C virus (HCV) infection from an HCV-positive donor kidney to an HCV-naive 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 Direct Acting Antiviral for HCV | Experimental | Drug: Direct Acting Antivirals8 weeks of treatment with HCV Direct Acting Antiviral tablet |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| Direct Acting AntiviralsAlso: Direct Acting Antiviral HCV Treatment8 weeks of DAA treatment | Drug | Treatment with Direct Acting Antiviral for HCV |
Primary outcome
Undetectable HCV RNA
Time frame: 12 weeks post-treatment
Negative HCV RNA 12 weeks after last dose of treatment
Rate of Serious and non-serious adverse events
Time frame: 1 year post-transplant
Determine safety of HCV+ to HCV- kidney transplantation by determining rate of adverse events related to HCV viremia or DAA 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 31 Aug 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Direct Acting Antivirals in people with Kidney Failure and Hepatitis C, run by Massachusetts General Hospital.
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: withdrawn, as of the sponsor's last update on 31 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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). The study lists 2 primary outcomes in all. 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 31 Aug 2022.