Utilising Volumetric Absorptive Microsampling (VAMS) Technology to Monitor Tacrolimus and Creatinine

NCT06445205 | Suspended DMC

• 2 other identifiers: 32256222/PR/1599
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant Rejection; Kidney Replacement

Outcome Measures

Primary Outcomes (2)

• Tacrolimus in Capillary Blood Samples

  That Tacrolimus is within range: 10-20ng/ml

  6 months

• Creatinine in Capillary Blood Samples

  That Creatinine is within range: 52.2 - 119.3 micromoles/L

  6 months

Secondary Outcomes (2)

• Tacrolimus is concordant with venous blood sample

  6 months

• Creatinine is concordant with venous blood sample

  6 months

Study Arms (1)

Sample collection

Sample collection via standard phlebotomy as well as point-or-care Mitra device.

Diagnostic Test: Mitra® device with VAMS® (volumetric absorptive microsampling) technology

Interventions

Mitra® device with VAMS® (volumetric absorptive microsampling) technology DIAGNOSTIC_TEST

Capillary blood sample

Sample collection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult renal transplant patients (\>18 years old) taking tacrolimus as an immunosuppressant

You may qualify if:

• Post renal transplant patients taking tacrolimus
• having regular bloods taken for tacrolimus and renal function testing.
• Patients must be taking tacrolimus as part of their immunosuppressive regimen.
• They must be over 18 years of age

You may not qualify if:

• Patients under the age of 18 (the study is for adults only).
• Vulnerable adults who are deemed unable to give consent themselves - If applicable, this can be assessed using the Trust clinical tool 'Assessment of Mental Capacity'.

Sponsors & Collaborators

• Lancashire Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, Lancashire, PR2 9HT, United Kingdom

Location

Study Officials

• Kina Bennett, PhD

  Lancashire Teaching Hospitals NHS Foundation Trust

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 6, 2024
• Study Start: February 13, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 8, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)