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End Stage Renal DiseasePhase 4NCT04614142

Single Patient Protocol for Donor HCV-positive to Recipient HCV-negative Kidney Transplant in a Patient at Risk for Loss of Dialysis Access

A Phase 4 study testing Glecaprevir / Pibrentasvir Oral Tablet [Mavyret] in people with End Stage Renal Disease and Chronic Hepatitis c, run by Massachusetts General Hospital at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a single patient, single center study evaluating if administration of pan-genotypic DAA therapy on day 3 (+/- 2 days) post-kidney transplant prevents 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 34 to 44 years, women only
Conditions the study is for
End Stage Renal Disease, Chronic Hepatitis c
What is being tested?
Glecaprevir / Pibrentasvir Oral Tablet [Mavyret]
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
13 Nov 2020to 4 Aug 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 34 to 44 years
  • Women only
  • No healthy volunteers
  • Adult

Donor Inclusion Criteria:

  • Detectable HCV Antibody Positivity
  • KDPI score is less than ≤ 0.650
  • Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation at MGH

Donor exclusion criteria

  • Donor has been known to have previously received and failed HCV treatment with a direct-acting antiviral agent
  • Confirmed HIV
  • Confirmed HBV positive (surface antigen or HBV DNA positive)
  • Kidney anatomical damage or significant pathology noted during recovery
  • Significant liver disease or signs of liver decompensation (splenomegaly, ascites) noted during recovery (advanced fibrosis or cirrhosis)
  • Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection)

Recipient Inclusion/Exclusion Criteria

  • Previously enrolled in IRB 2016P002051 and experienced primary graft nonfunction due to renal vein thrombosis and acute thrombotic microangiopathy
  • Willing and able to sign informed consent

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

Other trials in United States

About this study

This is a single patient, single center study evaluating if administration of pan-genotypic DAA therapy on day 3 (+/- 2 days) post-kidney transplant prevents the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient.

Read the detailed description

The patient selected for this study previously received a kidney transplant under protocol 2016P002051. Unfortunately, she experienced primary graft nonfunction due to a renal vein thrombus and acute thrombotic microangiopathy and the transplanted HCV+ kidney was removed. She continued glecaprevir and pibrentasvir for the full course (8 weeks of treatment) and was cured of HCV. However, she continues on dialysis requiring ongoing, albeit low dose, immunosuppression after her failed transplant. This causes increased risk of infection and other dialysis-related morbidity. Futhermore, she is at risk of access loss due to multiple failed fistula attempts and prior dialysis catheter line thrombosis. Of note, she also failed a trial of peritoneal dialysis due to development of a large pleural effusion (a known treatment-limiting complication of peritoneal dialysis). Thus, this young patient, is at risk of losing dialysis access which could lead to death. The MGH transplant team has now decided that she could be retransplanted with alterations in peri-transplant anticoagulation and immunosuppression (eculizumab) that they are confident should decrease her risk of peri-transplant thrombosis and recurrent TMA. Thus, we desire to expedite her access to re-transplant. Through this protocol, this recipient will be given the opportunity to accept a kidney that is HCV antibody positive and nucleic acid test (NAT) negative or HCV NAT positive and will be treated with oral glecaprevir (300mg)/pibrentasvir (120mg) (G/P, MavyretTM) on day 3 (+/- 2 days) post-kidney transplant to prevent the transmission of HCV infection at the time of transplant. Our goal is to provide access to kidney transplantation as soon as possible, with a donor of any genotype of infection, with elimination of the potential HCV infection by therapy used on day 3 (+/- 2 days) in the case of HCV NAT+ transplant and surveillance and reactive therapy in the case of HCV antibody positive NAT- transplant.

Being tested
Glecaprevir / Pibrentasvir Oral Tablet [Mavyret]
Keywords
kidney transplantation, hepatitis C, end stage renal disease
Medical subject headings
Kidney Failure, Chronic, Hepatitis C, Chronic, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glecaprevir / Pibrentasvir Oral Tablet [Mavyret]Drug

    The subject will begin an 8 week course of therapy with glecaprevir (100mg) / pibrentasvir (40mg) starting on day 3 (+/- 2 days) post-kidney transplantation from a hepatitis C positive donor.

Study groups in NCT04614142
Study groupRoleWhat they receive
Experimental: Glecaprevir/pibrentasvir for HCV+ kidney transplant recipientExperimentalGlecaprevir (100mg) / pibrentasvir (40mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor. Subject will receive first dose on day 3 (+/- 2 days) post-kideny transplantation and continue daily for 8 weeks.
Receives: Drug: Glecaprevir / Pibrentasvir Oral Tablet [Mavyret]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hepatitis C viral load (RNA)

    Negative hepatitis C viral load (RNA) tested using PCR at 12 weeks post-treatment (SVR12)

    Measured: 20 weeks post-transplant (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.

  1. First posted3 Nov 2020
  2. Study start13 Nov 2020
  3. Primary completion4 Aug 2021
  4. Study completion4 Aug 2021

Why it stopped: Single patient the protocol was written for consented to another study.

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04614142
Sponsor's protocol ID
2020P003265
Status last verified
Mar 2022
First submitted
28 Oct 2020
Last updated
8 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Data will not be shared outside of the research team.

Publications

  • Goldberg DS, Abt PL, Blumberg EA, Van Deerlin VM, Levine M, Reddy KR, Bloom RD, Nazarian SM, Sawinski D, Porrett P, Naji A, Hasz R, Suplee L, Trofe-Clark J, Sicilia A, McCauley M, Farooqi M, Gentile C, Smith J, Reese PP. Trial of Transplantation of HCV-Infected Kidneys into Uninfected Recipients. N Engl J Med. 2017 Jun 15;376(24):2394-2395. doi: 10.1056/NEJMc1705221. Epub 2017 Apr 30. No abstract available.

    PubMed 28459186

  • Reau N, Kwo PY, Rhee S, Brown RS Jr, Agarwal K, Angus P, Gane E, Kao JH, Mantry PS, Mutimer D, Reddy KR, Tran TT, Hu YB, Gulati A, Krishnan P, Dumas EO, Porcalla A, Shulman NS, Liu W, Samanta S, Trinh R, Forns X. Glecaprevir/Pibrentasvir Treatment in Liver or Kidney Transplant Patients With Hepatitis C Virus Infection. Hepatology. 2018 Oct;68(4):1298-1307. doi: 10.1002/hep.30046. Epub 2018 Jul 25.

    PubMed 29672891

  • Durand CM, Bowring MG, Brown DM, Chattergoon MA, Massaccesi G, Bair N, Wesson R, Reyad A, Naqvi FF, Ostrander D, Sugarman J, Segev DL, Sulkowski M, Desai NM. Direct-Acting Antiviral Prophylaxis in Kidney Transplantation From Hepatitis C Virus-Infected Donors to Noninfected Recipients: An Open-Label Nonrandomized Trial. Ann Intern Med. 2018 Apr 17;168(8):533-540. doi: 10.7326/M17-2871. Epub 2018 Mar 6.

    PubMed 29507971

  • Sise ME, Goldberg DS, Kort JJ, Schaubel DE, Alloway RR, Durand CM, Fontana RJ, Brown RS Jr, Friedewald JJ, Prenner S, Landis JR, Fernando M, Phillips CC, Woodle ES, Rike-Shields A, Sherman KE, Elias N, Williams WW, Gustafson JL, Desai NM, Barnaba B, Norman SP, Doshi M, Sultan ST, Aull MJ, Levitsky J, Belshe DS, Chung RT, Reese PP. Multicenter Study to Transplant Hepatitis C-Infected Kidneys (MYTHIC): An Open-Label Study of Combined Glecaprevir and Pibrentasvir to Treat Recipients of Transplanted Kidneys from Deceased Donors with Hepatitis C Virus Infection. J Am Soc Nephrol. 2020 Nov;31(11):2678-2687. doi: 10.1681/ASN.2020050686. Epub 2020 Aug 25.

    PubMed 32843477

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Glecaprevir / Pibrentasvir Oral Tablet [Mavyret] in people with End Stage Renal Disease and Chronic 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?

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 8 Mar 2022. 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?

Hepatitis C viral load (RNA) (time frame: 20 weeks post-transplant (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 NCT04614142, which also lists 4 linked publications.

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 8 Mar 2022.

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