BBRT: Blood-Bile Ratio Tacrolimus After Liver Transplantation

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Unknown status

CT.gov ID

NCT03882164

Collaborator

(none)

Enrollment

Location

14.3

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Liver Transplant; Complications Immunosuppression Transplant Failure Transplant; Complication, Rejection	Diagnostic Test: Blood-Bile Ratio of Tacrolimus

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

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

55 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 21, 2019

Anticipated Primary Completion Date :

Jul 1, 2019

Anticipated Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Rejection Patient undergone liver transplant with diagnosis of rejection within 10 days	Diagnostic Test: Blood-Bile Ratio of Tacrolimus Diagnosis of early transplanted liver dysfunction to adjust Tacrolimus dose adminstered
No-Rejection Patient undergone liver transplant wothout diagnosis of rejection within 10 days

Arm

Intervention/Treatment

Rejection

Patient undergone liver transplant with diagnosis of rejection within 10 days

Diagnostic Test: Blood-Bile Ratio of Tacrolimus

Diagnosis of early transplanted liver dysfunction to adjust Tacrolimus dose adminstered

No-Rejection

Patient undergone liver transplant wothout diagnosis of rejection within 10 days

Outcome Measures

Primary Outcome Measures

Analysis of early liver rejection [10 days]
Evaluation of early liver rejection throught creation of a Tacrolimus blood-bile ratio

Secondary Outcome Measures

Analysis of Tacrolimus toxicity [10 days]
Evaluation of Tacrolimus toxicity throught blood dosage of the drug

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Marco Maria Pascale	Roma	RM	Italy	00167

Sponsors and Collaborators

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Marco Maria Pascale, Resident, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

ClinicalTrials.gov Identifier:

NCT03882164

Other Study ID Numbers:

PoliclinicoUAG-LTU

First Posted:

Mar 20, 2019

Last Update Posted:

Mar 22, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Dr. Marco Maria Pascale, Resident, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Liver transplant;

Immunosuppression;

Transplant rejection;

Additional relevant MeSH terms:

Tacrolimus

Study Results

No Results Posted as of Mar 22, 2019