Mitra v Fingerprick Tacrolimus Creatinine

Not Applicable

• Conditions: Transplant;Failure,Kidney
• Interventions: Diagnostic Test: Mitra

• Registration Number: NCT03601208
• Lead Sponsor: Nottingham University Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-06
• Study First Submitted: 2018-06-25
• Study First Submitted QC: 2018-07-17
• Study First Posted: 2018-07-26
• Study Start: 2018-08
• Last Update Submitted: 2018-08-06
• Last Update Posted: 2018-08-08
• Primary Completion: 2018-10
• Study Completion: 2019-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Kidney transplant recipients. Taking tacrolimus

Exclusion Criteria

Unable to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood sample	Mitra	Venepuncture vs fingerprick test using Mitra volumetric absorptive microsampling (VAMs)

Primary Outcome Measures

Name	Time	Method
Comparison of creatinine and tacrolimus values for Mitra VAM (test) versus venous sampling (standard).	3 months	Compare blood results for creatinine and tacrolimus using two different methods - Mitra volumetric absorptive microsamplers (VAM) versus venous blood (standard).