Kidney Transplants in Hepatitis C Negative Recipients With Hepatitis C Viremic Donors
Primary Purpose
End Stage Renal Disease, Hepatitis C
Status
Active
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Glecaprevir/pibrentasvir
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease
Eligibility Criteria
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
Sites / Locations
- Johns Hopkins Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Deceased donor HCV RNA PCR+
Arm Description
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
Outcomes
Primary Outcome Measures
Viral Response as assessed by number of participants with undetectable hepatitis C RNA
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)).
Secondary Outcome Measures
Full Information
NCT ID
NCT04575896
First Posted
September 29, 2020
Last Updated
April 7, 2023
Sponsor
Johns Hopkins University
1. Study Identification
Unique Protocol Identification Number
NCT04575896
Brief Title
Kidney Transplants in Hepatitis C Negative Recipients With Hepatitis C Viremic Donors
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
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
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease, 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
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deceased donor HCV RNA PCR+
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Glecaprevir/pibrentasvir
Other Intervention Name(s)
Mavyret
Intervention Description
Glecaprevir/pibrentasvir 300mg/120mg once daily by mouth for 2 weeks post-transplant.
Primary Outcome Measure Information:
Title
Viral Response as assessed by number of participants with undetectable hepatitis C RNA
Description
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)).
Time Frame
12 weeks after completing therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niraj Desai, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32894697
Citation
Durand CM, Barnaba B, Yu S, Brown DM, Chattergoon MA, Bair N, Naqvi FF, Sulkowski M, Segev DL, Desai NM. Four-Week Direct-Acting Antiviral Prophylaxis for Kidney Transplantation From Hepatitis C-Viremic Donors to Hepatitis C-Negative Recipients: An Open-Label Nonrandomized Study. Ann Intern Med. 2021 Jan;174(1):137-138. doi: 10.7326/M20-1468. Epub 2020 Sep 8. No abstract available.
Results Reference
result
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Kidney Transplants in Hepatitis C Negative Recipients With Hepatitis C Viremic Donors
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