Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06342505
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2024-03-26
Brief Title:
Tacrolimus in CD3 T Lymphocytes
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
The Intracellular Pharmacokinetics of Tacrolimus in CD3 T Lymphocytes
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
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:
INTACT
Brief Summary:
The goal of this study is to measure concentrations of the drug tacrolimus in both whole blood and within T lymphocytes It will also learn on the correlation between the concentration in T lymphocytes and the effects of the drug The main questions are
i What is the ratio between the tacrolimus concentration within T lymphocytes and in whole blood ii What is the correlation between tacrolimus concentrations and the effects of the drug
Participants will
Receive standard clinical care
Undergo two extra venipunctures for the collection of blood
i What is the ratio between the tacrolimus concentration within T lymphocytes and in whole blood ii What is the correlation between tacrolimus concentrations and the effects of the drug
Participants will
Receive standard clinical care
Undergo two extra venipunctures for the collection of blood
Detailed Description:
Rationale The immunosuppressive drug tacrolimus is routinely monitored after kidney transplantation by measuring the whole blood pre-dose concentration C0 However the C0 has a poor correlation with clinical events most notably the risk of acute rejection Since tacrolimus site of action is within immune cells the intracellular tacrolimus concentration in peripheral blood mononuclear cells PBMCs has recently been proposed to better represent the active concentration However several studies could not demonstrate an association between the intracellular tacrolimus concentration and acute rejection One of the possible explanations for this surprising finding is the fact the PBMC fraction is composed of several cells including lymphocytes and monocytes In this study the tacrolimus concentration in CD3 T lymphocytes will be investigated as this may be a more relevant cell population than PBMCs
Objective To prospectively measure the intracellular tacrolimus concentration in CD3 T lymphocytes in kidney transplant recipients The area under the concentration-vs-time curve AUC of the intracellular tacrolimus concentration will be determined and used for the development of a population pharmacokinetic model The pharmacokinetics of intra-CD3 tacrolimus will be compared with the whole-blood concentration and will be related to important clinical events
Study design Observational study with additional blood sampling Study population Twenty-five de novo kidney transplant recipients receiving once-daily tacrolimus- as maintenance immunosuppression
Intervention Two extra venipunctures for the collection of blood
Objective To prospectively measure the intracellular tacrolimus concentration in CD3 T lymphocytes in kidney transplant recipients The area under the concentration-vs-time curve AUC of the intracellular tacrolimus concentration will be determined and used for the development of a population pharmacokinetic model The pharmacokinetics of intra-CD3 tacrolimus will be compared with the whole-blood concentration and will be related to important clinical events
Study design Observational study with additional blood sampling Study population Twenty-five de novo kidney transplant recipients receiving once-daily tacrolimus- as maintenance immunosuppression
Intervention Two extra venipunctures for the collection of blood
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