Kidney Transplant RejectionNCT06445205
Utilising Volumetric Absorptive Microsampling (VAMS) Technology to Monitor Tacrolimus and Creatinine
An observational study of Kidney Transplant Rejection and Kidney Replacement, run by Lancashire Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplant Rejection, Kidney Replacement
- What is being tested?
- Mitra® device with VAMS® (volumetric absorptive microsampling) technology
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Feb 2024to 30 Nov 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult renal transplant patients (>18 years old) taking tacrolimus as an immunosuppressant
Who may be able to join
- 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
Who cannot join
- 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'.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, Lancashire, PR2 9HT
About this study
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.
Read more
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.
Read the 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 manufacturer's instructions. Two venous blood samples will be collected from the patients by venepuncture by trained phlebotomists/nurses. 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-MS/MS). 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-MS/MS 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-MS/MS 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.
- Conditions
- Kidney Transplant Rejection, Kidney Replacement
- Being tested
- Mitra® device with VAMS® (volumetric absorptive microsampling) technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitra® device with VAMS® (volumetric absorptive microsampling) technologyDiagnostic test
Capillary blood sample
| Study group | Role | What they receive |
|---|---|---|
| Sample collection | Sample collection via standard phlebotomy as well as point-or-care Mitra device. Receives: Diagnostic Test: Mitra® device with VAMS® (volumetric absorptive microsampling) technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tacrolimus in Capillary Blood Samples
That Tacrolimus is within range: 10-20ng/ml
Measured: 6 months
Creatinine in Capillary Blood Samples
That Creatinine is within range: 52.2 - 119.3 micromoles/L
Measured: 6 months
Secondary outcomes (2)
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.
Measured: 6 months
Creatinine is concordant with venous blood sample
Results match standard venous results for Creatinine and is within range: 52.2 - 119.3 micromoles/L.
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 posted6 Jun 2024
- Study start13 Feb 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Why it stopped: Chief Investigator not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Transplant RejectionStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lancashire Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kina Bennett, PhD, Study chair, Lancashire Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445205
- Sponsor's protocol ID
- 322562
- Other IDs
- 22/PR/1599
- Status last verified
- May 2024
- First submitted
- 31 May 2024
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilising Volumetric Absorptive Microsampling (VAMS®) Technology to Monitor Tacrolimus and Creatinine Concentrations in Adult Renal Transplant Patients
- ClinicalTrials.gov ID
- NCT06445205
- Acronym / sponsor ID
- 322562
- Conditions
- Kidney Transplant Rejection, Kidney Replacement
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Chief Investigator not available
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Lancashire Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 13 Feb 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 6 Jun 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.
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.
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 manufacturer's instructions. Two venous blood samples will be collected from the patients by venepuncture by trained phlebotomists/nurses. 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-MS/MS). 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-MS/MS 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-MS/MS 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sample collection | – | Diagnostic Test: Mitra® device with VAMS® (volumetric absorptive microsampling) technologySample collection via standard phlebotomy as well as point-or-care Mitra device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult renal transplant patients (>18 years old) taking tacrolimus as an immunosuppressant
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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'.
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® device with VAMS® (volumetric absorptive microsampling) technologyCapillary blood sample | Diagnostic test | Sample collection |
Primary outcome
Tacrolimus in Capillary Blood Samples
Time frame: 6 months
That Tacrolimus is within range: 10-20ng/ml
Creatinine in Capillary Blood Samples
Time frame: 6 months
That Creatinine is within range: 52.2 - 119.3 micromoles/L
2 secondary outcomes
Tacrolimus is concordant with venous blood sample
Time frame: 6 months
Creatinine is concordant with venous blood sample
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- 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.
Kina Bennett, PhD study chair
Lancashire Teaching Hospitals NHS Foundation 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 Kidney Transplant Rejection and Kidney Replacement, run by Lancashire Teaching Hospitals NHS Foundation 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 4 inclusion and 2 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: paused, as of the sponsor's last update on 8 Apr 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?
Results are not available in the source record.
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?
Tacrolimus in Capillary Blood Samples (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Apr 2025.