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Monitoring Concentration and Pharmacodynamic Effects of Tacrolimus in Peripheral Blood Lymphocytes of Kidney Transplant Recipients

NCT03425071 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2018-02-07

No results posted yet for this study

Summary

Therapeutic drug monitoring (TDM) of immunosuppressive drugs is used to improve the immunosuppressive effect while minimizing the toxicity related to exposition to high serum levels. Although TDM is widely used in clinical practice, a significant number of kidney transplant recipients have acute allograft rejection in the first year after transplantation. To improve the use of immunosuppressive drugs, new approaches of TDM have been developed. Monitoring drug concentrations at lymphocytes of peripheral blood is considering promising because it indicates the availability of the drug directly in the target sites of immunosuppression. The present study intends to establish the concentration profile of tacrolimus in the peripheral blood in parallel with the concentration profile inside T and B lymphocytes of peripheral blood of kidney transplant recipients, and correlates them with the expected pharmacological effects. The pharmacological effects of tacrolimus in calcineurin dependent and calcineurin independent (mitogen-activated protein kinase (MAPK) dependent) activation pathways will be assessed by measuring activated nuclear factor of activated T cells (NFAT) and p38, respectively, by flow cytometry. The expression of interleukin (IL) - 2 and IL-10 by T and B lymphocytes, respectively, will be also used to monitoring the pharmacodynamic effects of tacrolimus.

Conditions

  • Kidney Transplantation
  • Rejection

Sponsors & Collaborators

  • Maria da Luz Fernandes

    collaborator UNKNOWN

  • Paschoalina Romano

    collaborator UNKNOWN

  • Persio de Almeida Rezende Ebner

    collaborator UNKNOWN

  • Nairo Massakazu Sumita

    collaborator UNKNOWN

  • Veronica Porto Carreiro de Vasconcelos Coelho

    collaborator UNKNOWN

  • Fabiana Agena

    collaborator UNKNOWN

  • Elias David Neto

    collaborator UNKNOWN

  • Nelson Zocoler Galante

    collaborator UNKNOWN

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Nelson Z Galante, PhD · Kidney Transplantation Service - University of Sao Paulo

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-08
Primary Completion
2018-07-31
Completion
2018-12-31

Countries

  • Brazil

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 NCT03425071 on ClinicalTrials.gov