OPTImization of the Dose of tacroliMUS by Bayesian Prediction

• Status: Completed
• Trial end date: 2020-09-21
• Target enrollment: 0
• Participant gender: All

Summary

The pharmacokinetics of tacrolimus (TAC) are characterized by high inter- and intra-individual variability with narrow therapeutic range. Currently, the limiting point of Tac drug monitoring is the inability to individualize doses during the first few days after transplantation. Our group developed a population pharmacokinetic model (PPK) identifying CYP3A4 * 22 and CYP3A5 * 3 polymorphisms and hematocrit as explanatory variables of the observed variability in pre-dose (Co) concentrations. According to this model, the proportion of patients that do not reach the therapeutic target is 40

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NURIA LLOBERAS BLANCH
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Kidney transplant recipients, from cadaveric and living donor.

• Patients that are going to receive immediate release Tacrolimus (Prograf/Adoport) as part of immunosuppressive treatment.

• Concomitant immunosuppression with Mycophenolate mofetil/Mycophenolic acid and steroids.

• Induction with Basiliximab is permitted.

• Subjects able to provide written informed consent.

• Female subjects of child-bearing potential must have a negative serum pregnancy test and must be practicing an effective, reliable, and medically approved contraceptive regimen during the study.

Exclusion Criteria:

• Subjects treated with drugs that can potentially interfere with Tacrolimus, especially CYP3A4 inhibitors (telaprevir, boceprevir, ritonavir, ketoconazole, voriconazole, itraconazole, telithromycin or clarithromycin) or CYP3A4 inductors (rifampicin or rifabutine).

• Subjects that receive induction treatment with Thymoglobulin or rituximab.

• Subjects participating in another investigational study within 30 days before inclusion.

• Subjects with hepatopathy.

• Subject or donor with a history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin .

• Female subjects who are pregnant or breast feeding.

• Subjects receiving an ABO incompatible kidney.

• Subjects have Donor Specific Antibodies.

• Recipients of an allograft with ischemic cold time > or = 24 hours.

• Subjects with a history of active hepatitis C virus (HCV-RNA positive) and/or hepatitis B virus (DNA-HBV or HBsAg positive) infection.

• Subjects with a history of human immunodeficiency virus (HIV-Ab positive) infection.

• Subjects with psychiatric or physical illness that could interfere with the ability of the subject to participate in the study.