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

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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Recruitment Status : Withdrawn (did not move forward with IRB approval, competing study)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

Tracking Information
First Submitted Date  ICMJE August 2, 2018
First Posted Date  ICMJE August 9, 2018
Last Update Posted Date June 3, 2019
Estimated Study Start Date  ICMJE February 15, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03623568 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2018)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant
Official Title  ICMJE Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Kidney Failure
  • Kidney Diseases
  • Hepatitis C
Intervention  ICMJE Drug: glecaprevir/pibrentasvir tablets
12 weeks of treatment with Mavyret
Other Name: Mavyret
Study Arms  ICMJE Experimental: Treatment with Mavyret (glecaprevir/pibrentasvir) for HCV
12 weeks of treatment with Mavyret
Intervention: Drug: glecaprevir/pibrentasvir tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 30, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 6, 2018)
25
Estimated Study Completion Date  ICMJE April 15, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03623568
Other Study ID Numbers  ICMJE 2018P001077
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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.
Responsible Party Raymond T. Chung, MD, Massachusetts General Hospital
Study Sponsor  ICMJE Raymond T. Chung, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Raymond T Chung, MD Massachusetts General Hospital
PRS Account Massachusetts General Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP