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

Primary Purpose

Kidney Failure, Kidney Diseases, Hepatitis C

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

glecaprevir/pibrentasvir tablets

About this trial

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

Eligibility Criteria

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

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.

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with Mavyret (glecaprevir/pibrentasvir) for HCV

Arm Description

12 weeks of treatment with Mavyret

Outcomes

Primary Outcome Measures

Undetectable HCV RNA in blood

Negative HCV viral RNA at 12 weeks after the last dose of treatment as determined by blood test

Secondary Outcome Measures

Safety (based on number of adverse events and out of range lab values) of DAA therapy in patients undergoing kidney transplantation)

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

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.

Full Information

NCT ID

NCT03623568

First Posted

August 2, 2018

Last Updated

May 30, 2019

Sponsor

Raymond T. Chung, MD

1. Study Identification

Unique Protocol Identification Number

NCT03623568

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Withdrawn

Why Stopped

did not move forward with IRB approval, competing study

Study Start Date

February 15, 2019 (Anticipated)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

April 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Raymond T. Chung, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure, Kidney Diseases, Hepatitis C

Keywords

CKD, HCV, Hepatitis C, 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

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment with Mavyret (glecaprevir/pibrentasvir) for HCV

Arm Type

Experimental

Arm Description

12 weeks of treatment with Mavyret

Intervention Type

Drug

Intervention Name(s)

glecaprevir/pibrentasvir tablets

Other Intervention Name(s)

Mavyret

Intervention Description

12 weeks of treatment with Mavyret

Primary Outcome Measure Information:

Title

Undetectable HCV RNA in blood

Description

Negative HCV viral RNA at 12 weeks after the last dose of treatment as determined by blood test

Time Frame

12 weeks post treatment

Secondary Outcome Measure Information:

Title

Safety (based on number of adverse events and out of range lab values) of DAA therapy in patients undergoing kidney transplantation)

Description

Time Frame

12 weeks post treatment

Title

Tolerability (based on number of adverse events and out of range lab values) of DAA therapy in patients undergoing kidney transplantation

Description

Time Frame

12 Weeks post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Raymond T Chung, 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

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anticipate to share coded data with collaborators

IPD Sharing Time Frame

Anticipate data would be available to share within 6 months after the final patient completes the study.

IPD Sharing 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.

Learn more about this trial

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

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