Ignite Creation Date:
2024-10-25 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585293
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-23
Brief Title:
Comparability of Fingerprick vs Venous Blood for Tacrolimus Monitoring
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Developing an LC-MSMS Method for Measurement of Tacrolimus and Creatinine Concentration From Finger-prick Blood Collected Using the Mitra Device
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Organ transplant rejection occurs when the immune system attacks the transplanted organ To prevent rejection transplant-patients are given immunosuppressant drugs which can suppress the immune system from attacking the transplanted organ Patients who have had a kidney-transplant take immunosuppressant drugs such as tacrolimus but the dosage must be closely monitored through regular blood tests to avoid complications like organ failure and kidney damage The current practice at Nottingham University Hospitals NHS Trust is that kidney-transplant patients being monitored for tacrolimus have regular blood samples taken by venepuncture vein and the samples are sent to the laboratory to be measured using liquid chromatography-tandem mass spectrometry LC-MSMS a technique used in chemistry to identify and quantify substances in a sample Patients will also often have their blood-creatinine measured to get an idea of kidney health Visits to the GPhospital for this type of blood collection can be disruptive to a patients daily life and stretches resources of the NHS An alternative blood sample collection process involves the use of a hand-held blood collecting device called a Mitra device designed to allow patients to collect samples at home through a finger-prick and send them by post for analysis This method is especially beneficial for those who find hospital visits challenging or venepuncture painful
This study aims to develop an LC-MSMS method for measurement of tacrolimus and creatinine using finger-prick samples collected on the Mitra device To do this kidney-transplant patients who are having routine venepuncture to measure tacrolimus and creatinine will simultaneously have a finger-prick sample collected using the Mitra device Both the venepuncture sample and finger-prick samples will be analysed using existing LC-MSMS technology to determine tacrolimus and creatinine values The LC-MSMS analysis method for the finger-prick samples collected using the Mitra device will be optimised and then results obtained using this method will be compared to the results obtained from venepuncture-collected samples to ensure consistency of results Agreement of results between the two analysis methods will confirm the suitability of LC-MSMS method for the measurement of tacrolimus and creatinine using samples collected using the Mitra device
This study aims to develop an LC-MSMS method for measurement of tacrolimus and creatinine using finger-prick samples collected on the Mitra device To do this kidney-transplant patients who are having routine venepuncture to measure tacrolimus and creatinine will simultaneously have a finger-prick sample collected using the Mitra device Both the venepuncture sample and finger-prick samples will be analysed using existing LC-MSMS technology to determine tacrolimus and creatinine values The LC-MSMS analysis method for the finger-prick samples collected using the Mitra device will be optimised and then results obtained using this method will be compared to the results obtained from venepuncture-collected samples to ensure consistency of results Agreement of results between the two analysis methods will confirm the suitability of LC-MSMS method for the measurement of tacrolimus and creatinine using samples collected using the Mitra device
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None