Transplant;Failure,KidneyNCT03601208
Mitra v Fingerprick Tacrolimus Creatinine
A study testing Mitra in people with Transplant;Failure,Kidney, run by Nottingham University Hospitals NHS Trust.
Trial summary
Patients with kidney transplant have blood tests very often. This is normally done in hospital and using a needle inserted into the vein. Two tests are important for kidney transplant patients - creatinine to monitor the health of the kidney; and tacrolimus to measure the level of the medicine which prevents… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transplant;Failure,Kidney
- What is being tested?
- Mitra
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2018to Jan 2019
- Phase
- Interventional
- 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
Who may be able to join
- Kidney transplant recipients. Taking tacrolimus
Who cannot join
- Unable to consent
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Standard Venous Sampling for Measurement of Tacrolimus and Creatinine Versus Fingerprick Mitra® Volumetric Absorptive Microsampling in Adult Renal Transplant Recipients
Patients with kidney transplant have blood tests very often. This is normally done in hospital and using a needle inserted into the vein. Two tests are important for kidney transplant patients - creatinine to monitor the health of the kidney; and tacrolimus to measure the level of the medicine which prevents rejection. The investigators would like to compare a fingerprick microsampling method to the standard venous blood. The fingerprick test is the same done by patients with diabetes and we use a microsampling tip which looks like a cotton bud to draw up a small amount of blood. Each tip draws up exactly 10 microlitres which is two drops. The investigators want to compare the results of creatinine and tacrolimus done through the two methods. In the future, this would allow patients to do their creatinine and tacrolimus test at home. The tips dry completely and can be posted to a laboratory. We hope this will make life easier for transplant patients and also help them engage more with the care of their condition.
- Conditions
- Transplant;Failure,Kidney
- Being tested
- Mitra
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MitraDiagnostic test
When the patients have their bloods done through venepuncture, an additional 5-10mls will be taken (one EDTA bottle for tacrolimus and one serum bottle for creatinine; and two Mitra VAMs). Patients will also have a fingerprick test and 20 microlitres of blood taken using Mitra volumetric absorptive microsampling (VAMs)
| Study group | Role | What they receive |
|---|---|---|
| Blood sample | Experimental | Venepuncture vs fingerprick test using Mitra volumetric absorptive microsampling (VAMs) Receives: Diagnostic Test: Mitra |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of creatinine and tacrolimus values for Mitra VAM (test) versus venous sampling (standard).
Compare blood results for creatinine and tacrolimus using two different methods - Mitra volumetric absorptive microsamplers (VAM) versus venous blood (standard).
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startAug 2018 (estimated)
- Primary completionOct 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant;Failure,KidneyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03601208
- Sponsor's protocol ID
- 18RE007
- Status last verified
- Jun 2018
- First submitted
- 25 Jun 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Standard Venous Sampling for Measurement of Tacrolimus and Creatinine Versus Fingerprick Mitra® Volumetric Absorptive Microsampling in Adult Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT03601208
- Acronym / sponsor ID
- 18RE007
- Conditions
- Transplant;Failure,Kidney
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Aug 2018 (estimated)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 26 Jul 2018 (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.
Patients with kidney transplant have blood tests very often. This is normally done in hospital and using a needle inserted into the vein. Two tests are important for kidney transplant patients - creatinine to monitor the health of the kidney; and tacrolimus to measure the level of the medicine which prevents rejection. The investigators would like to compare a fingerprick microsampling method to the standard venous blood. The fingerprick test is the same done by patients with diabetes and we use a microsampling tip which looks like a cotton bud to draw up a small amount of blood. Each tip draws up exactly 10 microlitres which is two drops. The investigators want to compare the results of creatinine and tacrolimus done through the two methods. In the future, this would allow patients to do their creatinine and tacrolimus test at home. The tips dry completely and can be posted to a laboratory. We hope this will make life easier for transplant patients and also help them engage more with the care of their condition.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sample | Experimental | Diagnostic Test: MitraVenepuncture vs fingerprick test using Mitra volumetric absorptive microsampling (VAMs) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Kidney transplant recipients. Taking tacrolimus
Key exclusion criteria (1 listed)
- Unable to consent
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 |
|---|---|---|
| MitraWhen the patients have their bloods done through venepuncture, an additional 5-10mls will be taken (one EDTA bottle for tacrolimus and one serum bottle for creatinine; and two Mitra VAMs). Patients will also have a fingerprick test and 20 microlitres of blood taken using Mitra volumetric absorptive microsampling (VAMs) | Diagnostic test | Blood sample |
Primary outcome
Comparison of creatinine and tacrolimus values for Mitra VAM (test) versus venous sampling (standard).
Time frame: 3 months
Compare blood results for creatinine and tacrolimus using two different methods - Mitra volumetric absorptive microsamplers (VAM) versus venous blood (standard).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Mitra in people with Transplant;Failure,Kidney, run by Nottingham University Hospitals NHS Trust.
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: status not confirmed, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Jon J Kim, MD (01159249924, jonjin.kim@nuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of creatinine and tacrolimus values for Mitra VAM (test) versus venous sampling (standard). (time frame: 3 months). 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 Aug 2018.