NCT03882164

Blood-Bile Ratio Tacrolimus After Liver Transplantation

Use of Tacrolimus Blood-bile Ratio for the Detection of Early Liver Failure After Liver Transplantation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 55 (actual)
• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Tacrolimus is the most widely used immunosuppressive drug in the prevention of rejection after solid organ transplantation. Pharmacokinetic studies in healthy volunteers and in transplanted patients have shown that this molecule is rapidly absorbed after oral administration (maximum plasma concentration after 1-2 hours), is found in the circulation bound mainly to erythrocytes and, after being metabolized by CYP3A4, is eliminated through the bile. The importance of the tacrolimus blood dosage is now widely recognized for detecting the immunosuppressive capacity reached in the individual patient or the eventual overdose of the drug. In the use of Tacrolimus after Liver Transplantation, however, it is interesting to note that the biochemical pathway for metabolism and excretion of the drug is present in the transplanted organ, the main object of immunological and functional surveillance. The excretory capacity of Tacrolimus by the liver through the bile, therefore, could be a useful tool for recognizing the early liver failure from a functional point of view, before the onset of hepatoecrosis.

Detailed description

Prospective monocentric randomized study comparing two parallel groups: liver transplanted patients with early (10 POD) organ rejection (experimental arm); liver transplanted patients without early (10 POD) organ rejection (control arm) Primary Objective: Evaluation of a correlation between the reduction of Tacrolimus biliary excretion and the early liver failure Primary Endpoint: Increase of Tacrolimus blood-bile ratio measured before the onset of laboratory hepatonecrosis Secondary Objective: Analysis of the cause of any drug-related toxicity Secondary Endpoint: correlation study between drug dosage and biliary excretion level in case of blood overdose or clinical evidence of pharmacological toxicity

Conditions

• Liver Transplant; Complications
• Immunosuppression
• Transplant Failure
• Transplant; Complication, Rejection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood-Bile Ratio of Tacrolimus	Diagnosis of early transplanted liver dysfunction to adjust Tacrolimus dose adminstered

Timeline

• Start date: 2019-02-21
• Primary completion: 2019-07-01
• Completion: 2020-05-01
• First posted: 2019-03-20
• Last updated: 2019-03-22

Locations

1 site across 1 country: Italy

Regulatory

• FDA-regulated drug study