OPTImization of the Dose of tacroliMUS by Bayesian Prediction

NCT03465410 | Completed Phase 4

• 1 other identifier: OPTIMUS
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

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 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

Conditions

KIDNEY TRANSPLANTATION

Outcome Measures

Primary Outcomes (1)

• Tacrolimus plasmatic concentrations measurement

  Concentration measured at day 6, 10, 15, 30, 60 and 90 post transplant and after each Tacrolimus dose adjustment

  Day 6, 10, 15, 30, 60 and 90 post transplant

Secondary Outcomes (2)

• Time to achieve Tacrolimus therapeutic target levels

  90 days

• Number of Tacrolimus dose changes to achieve target levels

  90 days

Study Arms (2)

GROUP I Standard adjustment

ACTIVE COMPARATOR

Standard dosage of Tacrolimus

Drug: Standard dosage of Tacrolimus

GROUP II Bayesian prediction adjustment

EXPERIMENTAL

Bayesian prediction Tacrolimus dosage

Drug: Bayesian Prediction Tacrolimus dosage

Interventions

Standard dosage of Tacrolimus DRUG

Immediate release Tacrolimus (Prograf/Adoport)

Also known as: Tacrolimus

GROUP I Standard adjustment

Bayesian Prediction Tacrolimus dosage DRUG

Immediate release Tacrolimus (Prograf/Adoport)

Also known as: Tacrolimus

GROUP II Bayesian prediction adjustment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• NURIA LLOBERAS BLANCH: lead

Study Sites (2)

Hospital Universitari de la Vall d'Hebron

Barcelona, Spain

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Spain

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Núria Lloberas, PhD

  Hospital Universitari de Bellvitge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized, prospective, multicenter study

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 14, 2018
• Study Start: March 21, 2017
• Primary Completion: September 21, 2020
• Study Completion: September 21, 2020
• Last Updated: January 8, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)