Blood-Bile Ratio Tacrolimus After Liver Transplantation

Immunosuppression Clinical Trial

— BBRT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03882164
• Other study ID #: PoliclinicoUAG-LTU
• Status: Active, not recruiting
• Start date: February 21, 2019
• Est. completion date: May 2020

Study information

• Verified date: March 2019
• Source: Policlinico Universitario Agostino Gemelli
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: May 2020
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age =18 years

• History of recent liver transplant (less than 10 days)

• Placement of kehr tube in the biliary tract during liver transplant

• Immunosuppressive therapy with Tacrolimus

• Functioning of kehr tube

Exclusion Criteria:

• Age - Age =18 years

• History of liver transplant for more than 10 days

• Liver transplant without positioning of kehr tube

• Immunosuppressive therapy with a drug different from Tacrolimus

• No functioning of kehr tube18 years

• History of liver transplant for more than 10 days

• Liver transplant without positioning of kehr tube

• Immunosuppressive therapy with a drug different from Tacrolimus

• No functioning of kehr tube

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• Blood-Bile Ratio of Tacrolimus
Diagnosis of early transplanted liver dysfunction to adjust Tacrolimus dose adminstered

Locations

Country	Name	City	State
Italy	Marco Maria Pascale	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
Policlinico Universitario Agostino Gemelli

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analysis of early liver rejection	Evaluation of early liver rejection throught creation of a Tacrolimus blood-bile ratio	10 days
Secondary	Analysis of Tacrolimus toxicity	Evaluation of Tacrolimus toxicity throught blood dosage of the drug	10 days