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Mitra v Fingerprick Tacrolimus Creatinine

Primary Purpose

Transplant;Failure,Kidney

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mitra
Sponsored by
Nottingham University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Transplant;Failure,Kidney

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    June 25, 2018
    Last Updated
    August 6, 2018
    Sponsor
    Nottingham University Hospitals NHS Trust
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    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

    Learn more about this trial

    Mitra v Fingerprick Tacrolimus Creatinine

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