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Tacrolimus Blood Concentration and Transplant-related Outcomes in Pediatric HSCT Recipients

NCT06080490 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 125

Last updated 2025-06-05

No results posted yet for this study

Summary

The goal of this retrospective observational study is to investigate any possible association among tacrolimus (TAC) blood concentrations, clinical efficacy and tolerability.

Therefore, the main questions it aims to answer are:

1. to clarify which variables, how and to what extent influence daily TAC blood concentrations in pediatric allo-hematopoietic stem cell transplantation (HSCT) recipients;
2. to investigate the incidence of graft-versus-host disease (GVHD) and graft failure according to TAC exposure.

Pediatric patients administered TAC to prevent GVHD after an allogeneic bone marrow transplantation.

Conditions

  • Graft Vs Host Disease
  • Transplant Failure
  • Stem Cell Transplant Complications

Interventions

DRUG

TAC C/D ratio

Pharmacokinetics of TAC according to possible influencing factors

Sponsors & Collaborators

  • University of Pisa

    lead OTHER

Principal Investigators

  • Natalia Maximova, MD · IRCCS Burlo Garofolo - Trieste - ITALY

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-29
Primary Completion
2024-09-29
Completion
2024-12-31
FDA Drug
Yes

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06080490 on ClinicalTrials.gov