Clinical trial for the identification of biomarkers based on "omic" techniques (study of large amounts of data), and their inter and intra-individual variability that allow the improvement in the individualization of tacrolimus treatment in pediatric patients with renal transplantation.

Identification of "omic" biomarkers and their inter and intra-individual variability that allow improvement in the individualization of tacrolimus: uncontrolled clinical trial in pediatric patients with renal transplantation.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-002795-13-ES

Enrollment

180

Registered

2020-02-21

Start date

2020-04-23

Completion date

Unknown

Last updated

2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric patients with renal transplantation (under stable treatment with tacrolimus as immunosuppressant)

Interventions

Trade Name: Tacrolimus STADA Product Name: TACROLIMUS Pharmaceutical Form: Tablet INN or Proposed INN: TACROLIMUS CAS Number: 104987-11-3 Concentration unit: mg milligram(s) Concentration type: range

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Subjects up to 18 years of age, both sexes included. - Kidney transplants. - Stable treatment with tacrolimus, as primary immunosuppressant, at the time of inclusion in the study. Stable treatment is considered when the variations in the last 3 determinations of tacrolimus levels are less than 30%, being these determinations a minimum of one week appart. - Individuals who, previously informed, grant their consent to participate in the study. Are the trial subjects under 18? yes Number of subjects for this age range: 180 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Incapacity to understand the instructions or collaborate during the development of the study. - Estimated glomerular filtration <30 mL / min / 1.73m2. - Graft rejection or dysfunction in the previous 6 months.

Design outcomes

Primary

Measure	Time frame
Main Objective: Determination of pharmacogenomic, metabolomic, proteomic and immunological markers that may be associated with intra and interindividual pharmacokinetic variability of tacrolimus in a pediatric population with stable renal transplantation.;Secondary Objective: 1. Study the associations between the different genetic, proteomic, metabolomic and immunological variables. 2. Study the associations between the AUC and the clinical variables collected prospectively and retrospectively in the study, such as renal function, viral load for CMV, polyomavirus and Epstein Barr virus, previous episodes of graft rejection, and immunological parameters. 3. Study the associations between the different genetic, proteomic, metabolomic and immunological variables with clinical variables collected prospectively and retrospectively in the study, such as renal function, viral load for CMV, polyomavirus and Epstein Barr virus, previous episodes of graft rejection, and immunological parameters.;Primary end point(s): Pharmacokinetic analysis. It will be calculated: - AUC through calculation formulas based on abbreviated sampling schemes that have been developed by our group. - Calculation of the pharmacokinetic parameters of tacrolimus using Bayesian populations pharmacokinetic methods. Pharmacogenetic study: genotypic characterization of the enzymes involved in the concentration of tacrolimus: CYP3A5, CYP3A4, CYP3A7, p-Gp and POR. Immunological analysis: measurement by flow cytometry of the expression of the OC40, CD25 and CD40L markers. Proteomic analysis: identification and quantification of plasma proteins. Metabolomic analysis: identification and quantification of each patient's metabolome.;Timepoint(s) of evaluation of this end point: It is estimated that between July 2020 and June 2021 the pharmacogenetic, proteomic, metabolomic and immunological studies will be conducted, as well as the analysis of the results.	—

Measure

Time frame

Main Objective: Determination of pharmacogenomic, metabolomic, proteomic and immunological markers that may be associated with intra and interindividual pharmacokinetic variability of tacrolimus in a pediatric population with stable renal transplantation.;Secondary Objective: 1. Study the associations between the different genetic, proteomic, metabolomic and immunological variables. 2. Study the associations between the AUC and the clinical variables collected prospectively and retrospectively in the study, such as renal function, viral load for CMV, polyomavirus and Epstein Barr virus, previous episodes of graft rejection, and immunological parameters. 3. Study the associations between the different genetic, proteomic, metabolomic and immunological variables with clinical variables collected prospectively and retrospectively in the study, such as renal function, viral load for CMV, polyomavirus and Epstein Barr virus, previous episodes of graft rejection, and immunological parameters.;Primary end point(s): Pharmacokinetic analysis. It will be calculated: - AUC through calculation formulas based on abbreviated sampling schemes that have been developed by our group. - Calculation of the pharmacokinetic parameters of tacrolimus using Bayesian populations pharmacokinetic methods. Pharmacogenetic study: genotypic characterization of the enzymes involved in the concentration of tacrolimus: CYP3A5, CYP3A4, CYP3A7, p-Gp and POR. Immunological analysis: measurement by flow cytometry of the expression of the OC40, CD25 and CD40L markers. Proteomic analysis: identification and quantification of plasma proteins. Metabolomic analysis: identification and quantification of each patient's metabolome.;Timepoint(s) of evaluation of this end point: It is estimated that between July 2020 and June 2021 the pharmacogenetic, proteomic, metabolomic and immunological studies will be conducted, as well as the analysis of the results.

—

Secondary

Measure	Time frame
Secondary end point(s): • Cross-associations between the different genetic, proteomic, metabolomic and immunological variables with each other. • Associations between the AUC and the clinical variables collected prospectively and retrospectively (as appropriate) in the study: - Renal function - Viral load for CMV, polyomavirus and Epstein Barr virus - Previous episodes of graft rejection - Immunological parameters. • Associations between the different genetic, proteomic, metabolomic and immunological variables with clinical variables collected prospectively and retrospectively (as appropriate) in the study. - Renal function - Viral load for CMV, polyomavirus and Epstein Barr virus - Previous episodes of graft rejection - Immunological parameters;Timepoint(s) of evaluation of this end point: It is estimated that between July 2020 and June 2021 the pharmacogenetic, proteomic, metabolomic and immunological studies will be conducted, as well as the analysis of the results.	—

Measure

Time frame

Secondary end point(s): • Cross-associations between the different genetic, proteomic, metabolomic and immunological variables with each other. • Associations between the AUC and the clinical variables collected prospectively and retrospectively (as appropriate) in the study: - Renal function - Viral load for CMV, polyomavirus and Epstein Barr virus - Previous episodes of graft rejection - Immunological parameters. • Associations between the different genetic, proteomic, metabolomic and immunological variables with clinical variables collected prospectively and retrospectively (as appropriate) in the study. - Renal function - Viral load for CMV, polyomavirus and Epstein Barr virus - Previous episodes of graft rejection - Immunological parameters;Timepoint(s) of evaluation of this end point: It is estimated that between July 2020 and June 2021 the pharmacogenetic, proteomic, metabolomic and immunological studies will be conducted, as well as the analysis of the results.

—

Countries

Spain

Contacts

Public ContactLucía Martínez de Soto

Fundación de Investigación Hospital Universitario La Paz

lucia.mdsoto@gmail.com0034912071466

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026