Status:
COMPLETED
OPTImization of the Dose of tacroliMUS by Bayesian Prediction
Lead Sponsor:
NURIA LLOBERAS BLANCH
Conditions:
KIDNEY TRANSPLANTATION
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 in...
Detailed Description
The results of the study of genetic polymorphisms performed in renal transplant patients at our hospital demonstrated the influence of CYP3A5 \* 3 and CYP3A4 \* 22 single nucleotide polymorphism (SNPs...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2020
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT03465410
Start Date
March 21 2017
End Date
September 21 2020
Last Update
January 8 2021
Active Locations (2)
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1
Hospital Universitari de la Vall d'Hebron
Barcelona, Spain
2
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Spain