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Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant

Primary Purpose

Renal Failure Chronic, Hepatitis C

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Zepatier
Zepatier plus Sofosbuvir
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  • Donor meets MGH transplant center criteria and already listed for isolated kidney transplant
  • No available living kidney donor
  • Recipient has ≤ 730 days of accrued transplant waiting time
  • Recipient chronic hemodialysis or peritoneal dialysis

  • Recipient must agree to birth control.

    °.Weigh ≥ 50kg

  • Serum ALT within normal limits
  • Subject's Insurance company approves payment for DAA therapy post-kidney transplant

Exclusion Criteria:

  • AB Blood type
  • HCV genotype 1
  • BMI > 35
  • Any liver disease in recipient
  • Pregnant or nursing (lactating) women
  • Known allergy or intolerance to tacrolimus that would require administration of cyclosporine
  • Albumin < 3g/dl or
  • Platelet count < 75 x 103/mL
  • Positive crossmatch or positive donor specific antibodies
  • HCV RNA positive
  • Hepatitis B surface antigen positive
  • Patients with primary focal segmental glomerulosclerosis (FSGS)
  • Any contra-indication to kidney transplantation per our center protocol

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HCV treatment - no viral resistance

HCV treatment - viral resistance

Arm Description

Based on the genotype and negative viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier

Based on the genotype and positive viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier plus Sofosbuvir

Outcomes

Primary Outcome Measures

Undetectable HCV RNA
Negative HCV viral load 12 weeks after last dose of treatment

Secondary Outcome Measures

Full Information

First Posted
March 22, 2017
Last Updated
December 18, 2018
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03093740
Brief Title
Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant
Official Title
Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Withdrew IRB application, never approved and no subjects enrolled
Study Start Date
October 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
January 31, 2021 (Anticipated)

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.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Open label single center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.
Detailed Description
The study objective is to determine if the administration of direct acting antivirals for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from donor kidney with known HCV infection (all genotypes) to an 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 Chronic, Hepatitis C
Keywords
hemodialysis, renal failure, kidney transplant

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Based on the genotype and viral resistance testing of the donor, that will be determined within the first week, we will initiate a genotype specific regimen for HCV treatment as available by prescription
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HCV treatment - no viral resistance
Arm Type
Experimental
Arm Description
Based on the genotype and negative viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier
Arm Title
HCV treatment - viral resistance
Arm Type
Experimental
Arm Description
Based on the genotype and positive viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier plus Sofosbuvir
Intervention Type
Drug
Intervention Name(s)
Zepatier
Intervention Description
Based on negative viral resistance testing of the donor treatment will be Zepatier
Intervention Type
Drug
Intervention Name(s)
Zepatier plus Sofosbuvir
Intervention Description
Based on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir
Primary Outcome Measure Information:
Title
Undetectable HCV RNA
Description
Negative HCV viral load 12 weeks after last dose of treatment
Time Frame
12 weeks post treatment

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: Donor meets MGH transplant center criteria and already listed for isolated kidney transplant No available living kidney donor Recipient has ≤ 730 days of accrued transplant waiting time Recipient chronic hemodialysis or peritoneal dialysis Recipient must agree to birth control. °.Weigh ≥ 50kg Serum ALT within normal limits Subject's Insurance company approves payment for DAA therapy post-kidney transplant Exclusion Criteria: AB Blood type HCV genotype 1 BMI > 35 Any liver disease in recipient Pregnant or nursing (lactating) women Known allergy or intolerance to tacrolimus that would require administration of cyclosporine Albumin < 3g/dl or Platelet count < 75 x 103/mL Positive crossmatch or positive donor specific antibodies HCV RNA positive Hepatitis B surface antigen positive Patients with primary focal segmental glomerulosclerosis (FSGS) Any contra-indication to kidney transplantation per our center protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond 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
No
IPD Sharing Plan Description
No current plans to share participant data

Learn more about this trial

Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant

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