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.

Phase 1

• Conditions: Pediatric patients with renal transplantation (under stable treatment with tacrolimus as immunosuppressant); Therapeutic area: Not possible to specify

• Registration Number: EUCTR2019-002795-13-ES
• Lead Sponsor: Fundación de Investigación Hospital Universitario La Paz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-21
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 180

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified