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Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03623568
Recruitment Status : Withdrawn (did not move forward with IRB approval, competing study)
First Posted : August 9, 2018
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Raymond T. Chung, MD, Massachusetts General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Kidney Failure Kidney Diseases Hepatitis C Drug: glecaprevir/pibrentasvir tablets Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant
Estimated Study Start Date : February 15, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment with Mavyret (glecaprevir/pibrentasvir) for HCV
12 weeks of treatment with Mavyret
Drug: glecaprevir/pibrentasvir tablets
12 weeks of treatment with Mavyret
Other Name: Mavyret




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    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.

  2. 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 ]
    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.



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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%)
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03623568


Locations
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United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Raymond T. Chung, MD
Investigators
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Principal Investigator: Raymond T Chung, MD Massachusetts General Hospital

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Responsible Party: Raymond T. Chung, MD, Director of Hepatology, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03623568     History of Changes
Other Study ID Numbers: 2018P001077
First Posted: August 9, 2018    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anticipate to share coded data with collaborators
Supporting Materials: Study Protocol
Time Frame: Anticipate data would be available to share within 6 months after the final patient completes the study.
Access Criteria: Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Raymond T. Chung, MD, Massachusetts General Hospital:
CKD
HCV
Hepatitis C
Transplant

Additional relevant MeSH terms:
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Hepatitis
Hepatitis C
Kidney Diseases
Renal Insufficiency
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Urologic Diseases
Antiviral Agents
Anti-Infective Agents