MedTrace Logo

The New LC-MS/MS Method for Determination of Unbound Tacrolimus in Plasma

NCT04657562 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 380

Last updated 2022-04-22

No results posted yet for this study

Summary

Tacrolimus (TAC) is characterized by a narrow therapeutic window, as well as high inter- and intra-individual variability in pharmacokinetics. Both under- and overexposure may lead to severe adverse effects. Therapeutic drug monitoring (TDM) is an essential element of post-transplant patient care. Most transplantation centers use C0 to adjust TAC dosage. Some controversies remain about relationship between C0 and clinical outcome.

It is generally accepted that only protein-unbound drug molecules can cross cellular membranes, which imply that TDM of free tacrolimus fraction may be of paramount importance and improve clinical management of organ recipients.

Whole blood TAC concentrations and dose requirements are strongly associated with CYP3A5 polymorphism. Routine CYP3A5 genotyping on the waiting lists might be useful to guide tacrolimus dosing.

This interdisciplinary project tackles the research problem from three angles - biochemistry, genetics and clinical observation. The primary goal of the study is to evaluate clinical usefulness of different TDM protocols in patients after kidney and liver transplantation.

Conditions

  • Immunosuppression
  • Kidney Transplant Rejection
  • Kidney Transplant; Complications
  • Liver Transplant Rejection
  • Liver Transplant; Complications
  • Metabolism Medication Toxicity
  • Genetic Predisposition

Interventions

DRUG

Tacrolimus

Prevention of rejection in kidney or liver transplant: a standard immunosuppressive therapy according to international protocols.

DIAGNOSTIC_TEST

Unbound tacrolimus measurement

Unbound tacrolimus measurement in plasma ultrafiltrate.

DIAGNOSTIC_TEST

CYP3A4 and CYP3A5 genotyping

DNA purification and genotyping

Sponsors & Collaborators

  • Medical University of Warsaw

    collaborator OTHER

  • National Science Centre, Poland

    lead OTHER_GOV

Principal Investigators

  • Karola Warzyszyńska, MD · Department of General and Transplant Surgery, Medical University of Warsaw

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2022-12-31
Completion
2023-05-31
FDA Drug
Yes

Countries

  • Poland

Study Locations

More Related Trials

Entities

Drugs

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 NCT04657562 on ClinicalTrials.gov