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Blood-Bile Ratio Tacrolimus After Liver Transplantation

NCT03882164 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2019-03-22

No results posted yet for this study

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

Blood-Bile Ratio of Tacrolimus

Diagnosis of early transplanted liver dysfunction to adjust Tacrolimus dose adminstered

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-21
Primary Completion
2019-07-31
Completion
2020-05-31
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03882164 on ClinicalTrials.gov