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Kidney Transplants in Hepatitis C Negative Recipients With Hepatitis C Viremic Donors

Sponsor
Johns Hopkins University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04575896
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
25.3
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 2 weeks post-renal transplant.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 2 weeks post-renal transplant. The participant will continue to be tested for Hepatitis C for 12 weeks post-treatment.

The primary hypothesis is that prophylactic treatment with glecaprevir/pibrentasvir before and after transplant will prevent the establishment of HCV infection in the recipients of kidneys from HCV-infected deceased donors. Based on the success of preliminary studies, the objective of the study is to evaluate the safety and efficacy of 2 weeks of G-P as prophylaxis for HCV D+/R- kidney transplant.

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open-label, Non-randomized Pilot Study to Determine the Safety and Efficacy of Two Weeks of Fixed-dose Glecaprevir and Pibrentasvir as Pre- and Post-exposure Prophylactic Therapy
Actual Study Start Date :
Nov 20, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Deceased donor HCV RNA PCR+

Participants who receive a kidney from HCV RNA PCR + deceased donor will receive glecaprevir/pibrentasvir 300 mg/120 mg once daily by mouth for 2 weeks

Drug: Glecaprevir/pibrentasvir
Glecaprevir/pibrentasvir 300mg/120mg once daily by mouth for 2 weeks post-transplant.
Other Names:
  • Mavyret

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Viral Response as assessed by number of participants with undetectable hepatitis C RNA [12 weeks after completing therapy]

      This is the number of participants with undetectable hepatitis C RNA in the blood at 12 weeks after stopping treatment (Number of kidney transplant recipients with HCV RNA < Lower Limit Of Quantification (LLOQ)).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Recipient Inclusion Criteria:

    • Participants ≥ 18 years old

    • On the deceased donor kidney waitlist at Johns Hopkins Hospital

    • Awaiting a first or second kidney transplant

    • No available living kidney donors

    • On hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease (CKD) defined as a glomerular filtration rate <15 ml/min for ≥ past 90 days

    • HCV-uninfected (by both antibody and RNA PCR) and without any behavioral risk factors for contracting HCV other than being on hemodialysis

    • Calculated panel reactive anti-human leukocyte antigens (anti-HLA) antibody (flow cPRA) below 80%

    Recipient Exclusion Criteria:

    • Plan to receive a multi-organ transplant

    • Plan to receive a dual kidney transplant (including en bloc)

    • History of prior solid organ transplant other than first kidney transplant

    • Participating in another study that involves an intervention or investigational product

    • Plan to receive a blood type incompatible kidney

    • History of human immunodeficiency (HIV), hepatitis C (HCV), or active hepatitis B (HBV) infection, defined as being on active antiviral treatment for HBV, detectable hepatitis B surface Ag or detectable hepatitis B DNA

    • Unable to safely substitute or discontinue a medication that is contraindicated with the study medication

    • Psychiatric or physical illness that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Hospital Baltimore Maryland United States 21205

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

    • Principal Investigator: Niraj Desai, MD, Johns Hopkins University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT04575896
    Other Study ID Numbers:
    • IRB00237097
    First Posted:
    Oct 5, 2020
    Last Update Posted:
    Dec 9, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis
    Kidney Failure, Chronic

    Study Results

    No Results Posted as of Dec 9, 2021