Mitra v Fingerprick Tacrolimus Creatinine

NCT03601208 | Unknown

• 1 other identifier: 18RE007
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Transplant;Failure,Kidney

Outcome Measures

Primary Outcomes (1)

• 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).

  3 months

Study Arms (1)

Blood sample

EXPERIMENTAL

Venepuncture vs fingerprick test using Mitra volumetric absorptive microsampling (VAMs)

Diagnostic Test: Mitra

Interventions

Mitra DIAGNOSTIC_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)

Blood sample

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Kidney transplant recipients. Taking tacrolimus

You may not qualify if:

• Unable to consent

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Central Study Contacts

Jon J Kim, MD

CONTACT

01159249924; jonjin.kim@nuh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 26, 2018
• Study Start: August 1, 2018
• Primary Completion: October 1, 2018
• Study Completion: January 1, 2019
• Last Updated: August 8, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share