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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04575896
• Other study ID #: IRB00237097
• Status: Completed
• Phase: Phase 4
• Start date: November 20, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 1, 2023
• Est. primary completion date: November 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• End Stage Renal Disease
• Hepatitis
• Hepatitis A
• Hepatitis C
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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-L — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)).	12 weeks after completing therapy