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QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir (QUICK-CURE)

Primary Purpose

Kidney Failure, Hepatitis C, Kidney Disease, Chronic

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Glecaprevir and Pibrentasvir
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Kidney Failure focused on measuring Kidney Transplant, Kidney Failure, HCV, Hepatitis C

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria (Recipient)

  1. Met MGH Transplant Center criteria and already listed for kidney transplant with stage 5 CKD / ESRD (eGFR <15 ml/min/1.73m2 or on renal replacement therapy)
  2. 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
  3. No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team
  4. Able to sign informed consent

Inclusion Criteria (Deceased Donor)

  1. Detectable HCV NAT test
  2. KDPI score is less than ≤ 0.850
  3. Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation

Exclusion Criteria (Recipient)

  1. Pregnant or nursing (lactating) women
  2. HBV positivity (Ag or DNA)
  3. Any contra-indication to kidney transplantation per MGH transplant center protocol
  4. Any signs or symptoms of clinically significant chronic liver disease per transplant center physician
  5. Inability to discontinue any medication with a known drug-drug interaction as listed in the G/P package insert

Exclusion Criteria (Deceased Donor)

  1. Confirmed HIV
  2. Confirmed HBV positive (surface antigen or HBV DNA positive)
  3. Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with Direct Acting Antiviral for HCV

Arm Description

4 week treatment period with glecaprevir and pibrentasvir (G/P) within 24 hours of transplant

Outcomes

Primary Outcome Measures

SVR12
Sustained virologic response 12 weeks after completing G/P

Secondary Outcome Measures

Adverse Events
Serious and non-serious adverse events attributed to study drug and/or HCV-viremia
HCV RNA Viral Load
Assessment of HCV RNA viral load at on-treatment visits
Allograft Function
Post-transplant allograft function measured by mean eGFR over study period
Rate of Death, Graft Failure, Acute Allograft Rejection, Delayed graft function, ALT elevation
The rate of clinical safety outcomes: death, graft failure, acute allograft rejection, delayed graft functions, ALT elevations > 5x ULN

Full Information

First Posted
August 13, 2020
Last Updated
October 6, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04515797
Brief Title
QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir
Acronym
QUICK-CURE
Official Title
QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a single center study characterizing the experience of administration of 4 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 the administration of glecaprevir and pibrentasvir (G/P) for 4 weeks beginning in the immediate peri-transplant period prevents establishment of HCV infection in HCV negative recipients receiving transplanted kidneys from HCV RNA positive donors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Failure, Hepatitis C, Kidney Disease, Chronic
Keywords
Kidney Transplant, Kidney Failure, HCV, Hepatitis C

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Treatment with Direct Acting Antiviral for HCV
Arm Type
Experimental
Arm Description
4 week treatment period with glecaprevir and pibrentasvir (G/P) within 24 hours of transplant
Intervention Type
Drug
Intervention Name(s)
Glecaprevir and Pibrentasvir
Other Intervention Name(s)
Direct Acting Antiviral HCV Treatment, Mavyret
Intervention Description
4 weeks of treatment starting within 24 hrs of kidney transplant
Primary Outcome Measure Information:
Title
SVR12
Description
Sustained virologic response 12 weeks after completing G/P
Time Frame
12 weeks post-treatment (16 weeks post-transplant)
Secondary Outcome Measure Information:
Title
Adverse Events
Description
Serious and non-serious adverse events attributed to study drug and/or HCV-viremia
Time Frame
1 Year Study Period
Title
HCV RNA Viral Load
Description
Assessment of HCV RNA viral load at on-treatment visits
Time Frame
Weeks 2 and 4 of Treatment
Title
Allograft Function
Description
Post-transplant allograft function measured by mean eGFR over study period
Time Frame
1 Year Study Period
Title
Rate of Death, Graft Failure, Acute Allograft Rejection, Delayed graft function, ALT elevation
Description
The rate of clinical safety outcomes: death, graft failure, acute allograft rejection, delayed graft functions, ALT elevations > 5x ULN
Time Frame
1 Year Study Period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria (Recipient) Met MGH Transplant Center criteria and already listed for kidney transplant with stage 5 CKD / ESRD (eGFR <15 ml/min/1.73m2 or on renal replacement therapy) 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 Inclusion Criteria (Deceased Donor) Detectable HCV NAT test KDPI score is less than ≤ 0.850 Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation Exclusion Criteria (Recipient) Pregnant or nursing (lactating) women HBV positivity (Ag or DNA) Any contra-indication to kidney transplantation per MGH transplant center protocol Any signs or symptoms of clinically significant chronic liver disease per transplant center physician Inability to discontinue any medication with a known drug-drug interaction as listed in the G/P package insert Exclusion Criteria (Deceased Donor) 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nahel Elias, MD
Organizational Affiliation
Massachusetts General Hospital
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

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QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir

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