ImmunosuppressionNCT06585293
Comparability of Fingerprick vs Venous Blood for Tacrolimus Monitoring
An observational study of Immunosuppression, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Immunosuppression
- What is being tested?
- Mitra Microsampling Device
- Type of treatment
- Medical device
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Jan 2025to 14 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients attending renal clinic who are receiving immunosuppressant treatment (tacrolimus) and require regular monitoring.
Who may be able to join
- Patients attending renal clinic who are receiving immunosuppressant treatment (tacrolimus) and require regular monitoring.
Who cannot join
- No exclusion criteria
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
About this study
Official title: Developing an LC-MS/MS Method for Measurement of Tacrolimus and Creatinine Concentration From Finger-prick Blood Collected Using the Mitra Device
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-MS/MS), 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 GP/hospital for this type of blood collection can be disruptive to a patient's 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-MS/MS 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-MS/MS technology to determine tacrolimus and creatinine values. The LC-MS/MS 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-MS/MS method for the measurement of tacrolimus and creatinine using samples collected using the Mitra device.
- Conditions
- Immunosuppression
- Being tested
- Mitra Microsampling Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitra Microsampling DeviceDevice
Microsampling tool for finger-prick blood collection
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of an in-house LC-MS/MS method and L4L-Analyst quantitative software for the measurement of tacrolimus and creatinine using capillary fingerprick samples collected with a Mitra device.
Validation of an in-house LC-MS/MS method for the measurement of tacrolimus and creatinine using capillary fingerprick samples collected with a Mitra device to UKAS standards, in accordance with ISO 15189, for routine clinical practice.
Measured: 6 months
Secondary outcomes (1)
Questionnaire to assess whether the new sample collection method improves patient experience
Patient satisfaction questionnaire using a 5-point likert scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2024
- Study start7 Jan 2025
- Primary completion14 Mar 2025
- Study completion14 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImmunosuppressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donna M Fullerton, PhD, FRCPath, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06585293
- Sponsor's protocol ID
- 24PA006
- Status last verified
- Jun 2025
- First submitted
- 23 Aug 2024
- Last updated
- 24 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marshall DJ, Kim JJ, Brand S, Bryne C, Keevil BG. Assessment of tacrolimus and creatinine concentration collected using Mitra microsampling devices. Ann Clin Biochem. 2020 Sep;57(5):389-396. doi: 10.1177/0004563220948886. Epub 2020 Aug 20.
PubMed 32713180
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an LC-MS/MS Method for Measurement of Tacrolimus and Creatinine Concentration From Finger-prick Blood Collected Using the Mitra Device
- ClinicalTrials.gov ID
- NCT06585293
- Acronym / sponsor ID
- 24PA006
- Conditions
- Immunosuppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 14 Mar 2025 (actual)
- Study completion
- 14 Mar 2025 (actual)
- First posted
- 5 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-MS/MS), 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 GP/hospital for this type of blood collection can be disruptive to a patient's 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-MS/MS 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-MS/MS technology to determine tacrolimus and creatinine values. The LC-MS/MS 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-MS/MS method for the measurement of tacrolimus and creatinine using samples collected using the Mitra device.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients attending renal clinic who are receiving immunosuppressant treatment (tacrolimus) and require regular monitoring.
Key inclusion criteria (1 listed)
- Patients attending renal clinic who are receiving immunosuppressant treatment (tacrolimus) and require regular monitoring.
Key exclusion criteria (1 listed)
- No exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitra Microsampling DeviceMicrosampling tool for finger-prick blood collection | Device | – |
Primary outcome
Validation of an in-house LC-MS/MS method and L4L-Analyst quantitative software for the measurement of tacrolimus and creatinine using capillary fingerprick samples collected with a Mitra device.
Time frame: 6 months
Validation of an in-house LC-MS/MS method for the measurement of tacrolimus and creatinine using capillary fingerprick samples collected with a Mitra device to UKAS standards, in accordance with ISO 15189, for routine clinical practice.
1 secondary outcome
Questionnaire to assess whether the new sample collection method improves patient experience
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Background: PubMed 32713180Marshall DJ, Kim JJ, Brand S, Bryne C, Keevil BG. Assessment of tacrolimus and creatinine concentration collected using Mitra microsampling devices. Ann Clin Biochem. 2020 Sep;57(5):389-396. doi: 10.1177/0004563220948886. Epub 2020 Aug 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna M Fullerton, PhD, FRCPath principal investigator
Nottingham University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunosuppression, run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of an in-house LC-MS/MS method and L4L-Analyst quantitative software for the measurement of tacrolimus and creatinine using capillary fingerprick samples collected with a Mitra device. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06585293, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.