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Mitra v Fingerprick Tacrolimus Creatinine

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ClinicalTrials.gov Identifier: NCT03601208
Recruitment Status : Unknown
Verified June 2018 by Nottingham University Hospitals NHS Trust.
Recruitment status was:  Not yet recruiting
First Posted : July 26, 2018
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
Nottingham University Hospitals NHS Trust

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment Phase
Transplant;Failure,Kidney Diagnostic Test: Mitra Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Standard Venous Sampling for Measurement of Tacrolimus and Creatinine Versus Fingerprick Mitra® Volumetric Absorptive Microsampling in Adult Renal Transplant Recipients
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arms and Interventions
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Arm Intervention/treatment
Experimental: Blood sample
Venepuncture vs fingerprick test using Mitra volumetric absorptive microsampling (VAMs)
 Diagnostic Test: Mitra
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)


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Kidney transplant recipients. Taking tacrolimus

Exclusion Criteria:

Unable to consent

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03601208


Contacts
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Contact: Jon J Kim, MD 01159249924 jonjin.kim@nuh.nhs.uk

Sponsors and Collaborators
Nottingham University Hospitals NHS Trust
More Information
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Responsible Party: Nottingham University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03601208    
Other Study ID Numbers: 18RE007
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Renal Insufficiency
Kidney Diseases
Urologic Diseases