Ignite Creation Date:
2024-05-06 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 12:39 PM
Study NCT ID:
NCT03425071
Status:
UNKNOWN
Last Update Posted:
2018-02-07
First Post:
2018-01-30
Brief Title:
Monitoring Concentration and Pharmacodynamic Effects of Tacrolimus in Peripheral Blood Lymphocytes of Kidney Transplant Recipients
Sponsor:
University of Sao Paulo General Hospital
Organization:
University of Sao Paulo General Hospital
Study Overview
Official Title:
Monitoring Intracellular Concentration and Pharmacodynamic Effects of Tacrolimus in Peripheral Blood T CD4 and B CD19 Lymphocytes of Kidney Transplant Recipients
Status:
UNKNOWN
Status Verified Date:
2018-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None