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mTOR inhibitor

Everolimus Conversion Arm for Liver Transplant

Phase 2
Waitlist Available
Led By Tomoaki Kato, MD
Research Sponsored by Tomoaki Kato
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

The purpose of this study is to evaluate the efficacy of an everolimus conversion (EVR) protocol as compared to the standard tacrolimus (TAC) based protocol in liver transplant recipients, as determined by renal function, rejection rates, and progression to fibrosis (in HCV positive subjects). Additionally, safety profile and tolerability of these regimens will be assessed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in estimated Glomerular Filtration Rate (eGFR)
Composite Efficacy Failure Rate
Incidence of Hepatocellular Carcinoma (HCC) Recurrence
+1 more

Side effects data

From 2017 Phase 4 trial • 60 Patients • NCT02096107
20%
Hospitalization
20%
Immunosuppression held or modified
10%
Infections
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care
Low Intensity Tacrolimus

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Everolimus Conversion ArmExperimental Treatment1 Intervention
Everolimus will be initiated within 24 hours of baseline at a dose of 1 mg po BID (2 mg/day). Therapeutic Drug Monitoring will be performed throughout the study. Tacrolimus should be eliminated when the everolimus target range has been reached. Complete tacrolimus elimination will not occur earlier than 90 days post transplant and no later than 120 days post transplant. Enteric coated mycopenolic acid will be maintained for the duration of the study. Oral corticosteroids may not be eliminated sooner than 180 days post transplantation. Everolimus doses will be adjusted based on local lab results of everolimus trough levels.
Group II: Standard Tacrolimus Immunosuppresion ArmActive Control1 Intervention
Subjects will be maintained on standard maintenance immunosuppression per local protocol, consisting of a tacrolimus plus enteric coated mycophenolic acid. Oral corticosteroids may not be eliminated sooner than 180 days post transplantation. Tacrolimus doses will be adjusted based on local lab results of tacrolimus trough levels.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
FDA approved

Find a Location

Who is running the clinical trial?

Tomoaki KatoLead Sponsor
Tomoaki Kato, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
6 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Everolimus Post Orthotopic Liver Transplant
Tomoaki Kato 2013. "Everolimus Post Orthotopic Liver Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01998789.
All > Liver Transplant > Afinitor
~4 spots leftby Apr 2025
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