Kidney Transplant Rejection Clinical Trial
Official title:
Utilising Volumetric Absorptive Microsampling (VAMS®) Technology to Monitor Tacrolimus and Creatinine Concentrations in Adult Renal Transplant Patients
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | November 30, 2024 |
Est. primary completion date | August 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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'. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Lancashire Teaching Hospitals NHS Foundation Trust | Preston | Lancashire |
Lead Sponsor | Collaborator |
---|---|
Lancashire Teaching Hospitals NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Tacrolimus in Capillary Blood Samples | That Tacrolimus is within range: 10-20ng/ml | 6 months | |
Primary | Creatinine in Capillary Blood Samples | That Creatinine is within range: 52.2 - 119.3 micromoles/L | 6 months | |
Secondary | Tacrolimus is concordant with venous blood sample | Results match standard venous results for Tacrolimus and is within range:10-20ng/ml then use of VAMS will be implemented into routine clinical practice for monitoring renal patients post transplant. | 6 months | |
Secondary | Creatinine is concordant with venous blood sample | Results match standard venous results for Creatinine and is within range: 52.2 - 119.3 micromoles/L. | 6 months |
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