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

NCT06445205 · Status: SUSPENDED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2025-04-08

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

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

Capillary blood sample

Sponsors & Collaborators

  • Lancashire Teaching Hospitals NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Kina Bennett, PhD · Lancashire Teaching Hospitals NHS Foundation Trust

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-13
Primary Completion
2026-08-31
Completion
2026-11-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06445205 on ClinicalTrials.gov