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Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant

Primary Purpose

Renal Failure

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Failure focused on measuring hemodialysis, peritoneal dialysis, renal failure, kidney transplant

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Must meet Massachusetts General Hospital (MGH) transplant center criteria and already be listed for isolated kidney transplant
  2. No available living kidney donor
  3. 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.
  4. On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate <15mL/min/1.73m2 at the time of screening
  5. Weight ≥ 50kg
  6. Serum alanine transaminase (ALT) within normal limits

Exclusion Criteria:

  1. AB blood type
  2. Body mass index (BMI > 35
  3. History of liver disease
  4. Pregnant or nursing (lactating) women
  5. Cardiomyopathy (LV ejection fraction < 50%)
  6. Positive crossmatch or positive donor specific antibodies
  7. Human immunodeficiency virus (HIV) positive
  8. Hepatitis C virus (HCV) RNA positive
  9. Hepatitis B virus (HBV) surface antigen positive
  10. Any contraindication to kidney transplant per MGH center protocol

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elbasvir/grazoprevir for HCV+ kidney transplant recipients

Arm Description

Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).

Outcomes

Primary Outcome Measures

Number of Participants With Undetectable HCV RNA at SVR12
Sustained virologic response at 12-weeks post-treatment (SVR12), as defined by negative HCV viral load, after 12-16 weeks of elbasvir/grazoprevir treatment in patients who receive a kidney transplant from a deceased donor infected with HCV.

Secondary Outcome Measures

Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 14, 28, 56, 84, 112, 168, 252, 365
Subjects had Hepatitis C viral load assessed at each study visit. Here we looked at the proportion of subjects with undetectable serum HCV RNA at study day 7, 14, 28, 56, 84, 112, 168, 252, 365.

Full Information

First Posted
October 21, 2016
Last Updated
May 19, 2020
Sponsor
Massachusetts General Hospital
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02945150
Brief Title
Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant
Official Title
A Proof of Concept Study of Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
August 20, 2019 (Actual)
Study Completion Date
March 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Proof of concept, open-label single center study for the donation of HCV positive kidneys to HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission upon transplantation.
Detailed Description
The study objective is to determine if the administration of grazoprevir and elbasvir (with or without ribavirin) for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from a donor kidney with known HCV genotype 1 or 4 infection to a HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure
Keywords
hemodialysis, peritoneal dialysis, renal failure, kidney transplant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elbasvir/grazoprevir for HCV+ kidney transplant recipients
Arm Type
Experimental
Arm Description
Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).
Intervention Type
Drug
Intervention Name(s)
elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination)
Other Intervention Name(s)
Zepatier
Intervention Description
Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).
Primary Outcome Measure Information:
Title
Number of Participants With Undetectable HCV RNA at SVR12
Description
Sustained virologic response at 12-weeks post-treatment (SVR12), as defined by negative HCV viral load, after 12-16 weeks of elbasvir/grazoprevir treatment in patients who receive a kidney transplant from a deceased donor infected with HCV.
Time Frame
12 weeks post-treatment (24 weeks post-transplant)
Secondary Outcome Measure Information:
Title
Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 14, 28, 56, 84, 112, 168, 252, 365
Description
Subjects had Hepatitis C viral load assessed at each study visit. Here we looked at the proportion of subjects with undetectable serum HCV RNA at study day 7, 14, 28, 56, 84, 112, 168, 252, 365.
Time Frame
1 year post transplant

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must meet Massachusetts General Hospital (MGH) transplant center criteria and already be listed for isolated 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 Weight ≥ 50kg Serum alanine transaminase (ALT) within normal limits Exclusion Criteria: AB blood type Body mass index (BMI > 35 History of liver disease Pregnant or nursing (lactating) women Cardiomyopathy (LV ejection fraction < 50%) Positive crossmatch or positive donor specific antibodies Human immunodeficiency virus (HIV) positive Hepatitis C virus (HCV) RNA positive Hepatitis B virus (HBV) surface antigen positive Any contraindication to kidney transplant per MGH center protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Chung, MD
Organizational Affiliation
Massachusetts General Hospital (Partners Healthcare)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared with study sponsor and with the hopes of publication.
IPD Sharing Time Frame
Protocol will be shared for up to 1 year after the final patient has dosed.
IPD Sharing Access Criteria
Protocol will only be shared with Institutional Review Board (IRB) approved study staff and PI approved collaborators.
Citations:
PubMed Identifier
20353475
Citation
Kucirka LM, Singer AL, Ros RL, Montgomery RA, Dagher NN, Segev DL. Underutilization of hepatitis C-positive kidneys for hepatitis C-positive recipients. Am J Transplant. 2010 May;10(5):1238-46. doi: 10.1111/j.1600-6143.2010.03091.x. Epub 2010 Mar 26.
Results Reference
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Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant

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