Rezafungin Prophylaxis in Liver Transplant

NCT06774144 | Enrolling By Invitation Phase 3 FDA Drug

• 1 other identifier: STUDY24080165
• Study Type: interventional
• Target: 385
• Locations: 1 country
• Sites: 1

Brief Summary

This is an interventional study to evaluate the efficacy of rezafungin, a new echinocandin, for the prevention of invasive fungal infections (IFIs) after liver transplantation. Patients who receive rezafungin will be compared to a similar group of patients who underwent liver transplantation in the preceding two years for the incidence of IFIs.

Conditions

Liver Transplant Infection; Fungal Infection

Keywords

rezafungin; liver transplant; prophylaxis

Outcome Measures

Primary Outcomes (2)

• Incidence of proven and probable IFIs

  Incidence of proven and probable IFIs within 90 days post-transplant

  90 days post-transplant

• Incidence of proven and probable breakthrough IFI

  Incidence of breakthrough IFI while on specific antifungal prophylaxis

  While receiving rezafungin, voriconazole, or fluconazole

Secondary Outcomes (7)

• Fungal-free survival

  90 days and 6 months post-transplant

• Fungal colonization

  90 days and 6 months post-transplant

• Graft rejection

  90 days and 6 months post-transplant

• Graft loss

  90 days 6 months post-transplant

• All-cause mortality

  90 days 6 months post-transplant

Other Outcomes (2)

• Pharmakokinectics (PK) of rezafungin

  Up to 4 weeks post-transplant

• Stool microbiota composition

  Within 6 months post-transplant

Study Arms (3)

Prospective Intervention Cohort

EXPERIMENTAL

Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV once weekly for a total duration of 4 weeks

Drug: Rezafungin

Prospective Control Cohort

ACTIVE COMPARATOR

Patients who receive fluconazole/voriconazole or no antifungal prophylaxis as part of UPMC's risk-based antifungal prophylaxis standard of care after liver transplant

Drug: Standard of care antifungal prophylaxis

Historical Control Group

ACTIVE COMPARATOR

Patients at risk for IFI who received fluconazole/voriconazole for antifungal prophylaxis after liver transplant in the two years preceding the study

Drug: Standard of care antifungal prophylaxis

Interventions

Rezafungin DRUG

Rezafungin 400 mg IV once within 24 hours of liver transplant, followed by 200 mg IV weekly for 4 weeks.

Prospective Intervention Cohort

Standard of care antifungal prophylaxis DRUG

UPMC uses a tiered approach to antifungal prophylaxis, based on risk factors for IFI. Fluconazole is used for recipients with risk factors for yeast infections: choledochojejunostomy, prolonged transplant time, receipt of \>40 units of blood products within 24 hours of transplant, and Candida colonization or infection within 3 months prior to transplant. Voriconazole is used for recipients with risk factors for mould infections: re-transplantation, renal failure requiring renal replacement therapy, fulminant hepatic failure as indication for transplant, intra-abdominal/thoracic re-exploration within the first month after transplant. No prophylaxis is given if there are no risk factors for yeast or mould infections.

Also known as: Fluconazole, voriconazole, or no prophylaxis

Historical Control Group; Prospective Control Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Liver transplant recipient
• years of age or older
• ≥1 risk factor(s) for IFI: living donor transplant, retransplantation, complicated operations (based on duration of transplant and number of blood products required in the peri-transplant period), choledochojejunostomy anastomosis, or peri-operative Candida colonization, recent Candida infection, renal replacement therapy post-transplant, and reoperation within the first 90 days of transplant.

You may not qualify if:

• Participants who are perceived not to survive past 7 days after transplant
• Participants who elect not to participate in the prospective trial
• Participants who had active candidiasis at the time of transplant
• Participants with a history of allergy to an echinocandin
• Participants who are pregnant.

Sponsors & Collaborators

• Fernanda P Silveira, MD, MS: lead
• Melinta Therapeutics: collaborator

Study Sites (1)

UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Mycoses

Interventions

Rezafungin; Fluconazole; Voriconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Fernanda Silveira

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Model Details: Interventional, open-label, single center study with concurrent and historical controls

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: January 14, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)