Mitra v Fingerprick Tacrolimus Creatinine
Primary Purpose
Transplant;Failure,Kidney
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mitra
Sponsored by
About this trial
This is an interventional diagnostic trial for Transplant;Failure,Kidney
Eligibility Criteria
Inclusion Criteria:
Kidney transplant recipients. Taking tacrolimus
Exclusion Criteria:
Unable to consent
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blood sample
Arm Description
Venepuncture vs fingerprick test using Mitra volumetric absorptive microsampling (VAMs)
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT03601208
First Posted
June 25, 2018
Last Updated
August 6, 2018
Sponsor
Nottingham University Hospitals NHS Trust
1. Study Identification
Unique Protocol Identification Number
NCT03601208
Brief Title
Mitra v Fingerprick Tacrolimus Creatinine
Official Title
Comparison of Standard Venous Sampling for Measurement of Tacrolimus and Creatinine Versus Fingerprick Mitra® Volumetric Absorptive Microsampling in Adult Renal Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 2018 (Anticipated)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
January 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottingham University Hospitals NHS Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transplant;Failure,Kidney
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blood sample
Arm Type
Experimental
Arm Description
Venepuncture vs fingerprick test using Mitra volumetric absorptive microsampling (VAMs)
Intervention Type
Diagnostic Test
Intervention Name(s)
Mitra
Intervention Description
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)
Primary Outcome Measure Information:
Title
Comparison of creatinine and tacrolimus values for Mitra VAM (test) versus venous sampling (standard).
Description
Compare blood results for creatinine and tacrolimus using two different methods - Mitra volumetric absorptive microsamplers (VAM) versus venous blood (standard).
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Kidney transplant recipients. Taking tacrolimus
Exclusion Criteria:
Unable to consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jon J Kim, MD
Phone
01159249924
Email
jonjin.kim@nuh.nhs.uk
12. IPD Sharing Statement
Plan to Share IPD
No
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Mitra v Fingerprick Tacrolimus Creatinine
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