Kidney Transplants in Hepatitis C Negat… | Clinical Trial

Key information

Conditions

End Stage Renal Disease Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Kidney Diseases Kidney Failure, Chronic Liver Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glecaprevir/Pibrentasvir

Drug

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

Other names: Mavyret

Primary outcomes

Viral Response as Assessed by Number of Participants With Undetectable Hepatitis C RNA

Time frame: 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)).

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study 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

Important dates

Study start: 2020
Primary completion: 2023
Study completion: 2023
First posted: Oct 5, 2020
Registry last updated: Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed