Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06445205
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-31
Brief Title:
Utilising Volumetric Absorptive Microsampling VAMS Technology to Monitor Tacrolimus and Creatinine
Sponsor:
Lancashire Teaching Hospitals NHS Foundation Trust
Organization:
Lancashire Teaching Hospitals NHS Foundation Trust
Study Overview
Official Title:
Utilising Volumetric Absorptive Microsampling VAMS Technology to Monitor Tacrolimus and Creatinine Concentrations in Adult Renal Transplant Patients
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
Tacrolimus is a medicine given to try and stop rejection of a new kidney after transplant surgery If too much taken the kidney may be damaged If not enough taken the risk of rejection is increased Creatinine is a waste product made by the muscles and is normally removed from the body by the kidneys If kidney function gets worse the creatinine level in the blood goes up and means the new new kidney is not working properly It is important to monitor levels of tacrolimus and creatinine regularly to keep the kidney as healthy as possible Regular monitoring also aids with balancing the amount of tacrolimus that patients need to take
The COVID-19 pandemic led to changes in the delivery of transplant services One such changes was a move to the use of point-of-care and at home devices
The study involves the set-up a new method in an NHS laboratory to test tacrolimus and creatinine levels in blood collected in the normal blood tubes and to compare the results with this new collection device to see if the results are the same
If the results match patients will continue to collect a blood sample using the new devices and send it to the laboratory This will save both patients and the NHS time and money as they will not have to travel to a hospital to have their bloods taken
The COVID-19 pandemic led to changes in the delivery of transplant services One such changes was a move to the use of point-of-care and at home devices
The study involves the set-up a new method in an NHS laboratory to test tacrolimus and creatinine levels in blood collected in the normal blood tubes and to compare the results with this new collection device to see if the results are the same
If the results match patients will continue to collect a blood sample using the new devices and send it to the laboratory This will save both patients and the NHS time and money as they will not have to travel to a hospital to have their bloods taken
Detailed Description:
A minimum of 50 adult renal transplant patients 18 years old taking tacrolimus as an immunosuppressant will be recruited when attending their routine outpatient follow up appointment or if selected as eligible by the Renal Consultants and transplant nurses Written consent will be obtained from all participants
Patients attending blood clinic to have their routine blood samples taken will also have a finger prick and a small amount of blood 10µl will be collected by volumetric absorptive micro sampling VAMS using the Mitra device Neoteryx according to manufacturers instructions Two venous blood samples will be collected from the patients by venepuncture by trained phlebotomistsnurses A 4ml EDTA and a 4ml serum gel sample to measure tacrolimus and renal function as part of routine care Tacrolimus and creatinine are measured in venous blood samples as part of routine patient care therefore these will be processed as normal and results reported The paired capillary samples collected using the Mitra device will be batched and run when appropriate by liquid chromatography-mass spectrometry LC-MSMS Mitra devices will be stored at -20 degree Celsius prior to analysis
Venous EDTA whole blood samples collected by venepuncture and capillary whole blood samples collected by VAMS will be analysed for tacrolimus using a validated LC-MSMS assay in routine clinical use in the lab using the Waters ACQUITY UPLC system and Xevo TQD MS Capillary whole blood samples collected by VAMS and serum samples will be analysed for creatinine using an LC-MSMS method which will be developed in house For the method comparison serum samples collected by venepuncture will be analysed for creatinine using an enzymatic method on the Roche platform All sample analysis will be performed in an ISO 15189 accredited laboratory
Patients attending blood clinic to have their routine blood samples taken will also have a finger prick and a small amount of blood 10µl will be collected by volumetric absorptive micro sampling VAMS using the Mitra device Neoteryx according to manufacturers instructions Two venous blood samples will be collected from the patients by venepuncture by trained phlebotomistsnurses A 4ml EDTA and a 4ml serum gel sample to measure tacrolimus and renal function as part of routine care Tacrolimus and creatinine are measured in venous blood samples as part of routine patient care therefore these will be processed as normal and results reported The paired capillary samples collected using the Mitra device will be batched and run when appropriate by liquid chromatography-mass spectrometry LC-MSMS Mitra devices will be stored at -20 degree Celsius prior to analysis
Venous EDTA whole blood samples collected by venepuncture and capillary whole blood samples collected by VAMS will be analysed for tacrolimus using a validated LC-MSMS assay in routine clinical use in the lab using the Waters ACQUITY UPLC system and Xevo TQD MS Capillary whole blood samples collected by VAMS and serum samples will be analysed for creatinine using an LC-MSMS method which will be developed in house For the method comparison serum samples collected by venepuncture will be analysed for creatinine using an enzymatic method on the Roche platform All sample analysis will be performed in an ISO 15189 accredited laboratory
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 22PR1599 | OTHER | Health research Authority | None |