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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03882164
Other study ID # PoliclinicoUAG-LTU
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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