Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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)

Study Design

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

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Treatment with Direct Acting Antiviral for HCV
4 week treatment period with glecaprevir and pibrentasvir (G/P) within 24 hours of transplant
  • Drug: Glecaprevir and Pibrentasvir
    4 weeks of treatment starting within 24 hrs of kidney transplant
    Other names:
    • Direct Acting Antiviral HCV Treatment
    • Mavyret

Recruiting Locations

Massachusetts General Hospital
Boston, Massachusetts 02114
Contact:
Margaret Thomas
617-643-6266
MVTHOMAS@mgh.harvard.edu

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Nahel Elias, MD
6177260174
Elias.Nahel@mgh.harvard.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.