Tacrolimus Microsampling (VAMS)

Development of an Assay for Tacrolimus Blood Trough Measurement in Pediatric Heart Transplant Patients Using Volumetric Absorptive Microsampling (VAMS) and Stable-Labeled Isotope Dilution Tandem Mass Spectrometry.

This is a feasibility study at a single site, Cincinnati Children's Hospital Medical Center. Patients who have undergone heart transplantation who meet eligibility requirements will be approached to participate in the study. The purpose of this study is to establish a reliable, home-based method for collecting samples as well as a standardized method for use of small-volume samples on both inpatients and outpatients.

Study Overview

• Status: Completed
• Conditions: Validate Volumetric Absorptive Microsampling (VAMS) Assay
• Intervention / Treatment: Device: Mitra Microsampler

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Pediatric, adolescent, or young adult patients ≥1 and ≤21 years of age

   1. Aim 1: All patients presenting for routine post-transplant care including, but not limited to: cardiac catheterization, cardiac biopsy, inpatient admission, or outpatient visits
   2. Aim 2: outpatient
2. Currently taking tacrolimus

Exclusion Criteria:

1. Non-English-speaking patients
2. Unable to access overnight delivery services (Aim 2 only)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aim 1; All patients presenting for routine post-transplant care including, but not limited to: cardiac catheterization, cardiac biopsy, inpatient admission, or outpatient visits. A convenience sample of 25 inpatient samples will be collected for Aim 1. Although the assay developed by the MSCF will be validated for accuracy, the purpose of Aim 1 is to test "real world" application of the Mitra Microsampler tubes against the gold standard of blood collected by venipuncture in a controlled setting. To accomplish this, consecutive inpatient heart transplant patients will be enrolled. That sample will be collected at the same time (+/- 15 minutes) as a clinically-indicated, appropriately-timed venipuncture for measurement of a tacrolimus trough and prior to the subject taking tacrolimus so as to represent a trough.	Device: Mitra Microsampler; an FDA Class I medical device for direct specimen collection of blood or other biological fluids
Experimental: Aim 2; Outpatient. A convenience sample of 25 outpatients collecting 1-2 samples will be collected for Aim 2. For those who agree to participate, the parent/patient will be taught by a member of the team on how to use the Microsampler to collect blood from a finger stick. They will be provided with a kit for collection of up to 2 samples and will also be provided with appropriate shipping materials to return samples to CCHMC. Participants will then be instructed to collect a sample in the Mitra Microsampler via fingerstick. In addition to the process of collecting the sample in Aim 2, appropriately-aged participants and/or families will be asked to fill out a brief survey regarding sample collection. This will include questions about the ease or difficulty of performing the steps and tolerability of the procedure relative to past experiences with values obtained by venipuncture.	Device: Mitra Microsampler; an FDA Class I medical device for direct specimen collection of blood or other biological fluids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of +/-10%	A VAMS-based tacrolimus trough values will be accurate +/-10% when compared with standard whole blood values achieved via venipuncture.	18-24 months from start of enrollment

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Investigators: Principal Investigator: Thomas C Ryan, Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2019
• Primary Completion (Actual): January 3, 2022
• Study Completion (Actual): July 28, 2022

Study Registration Dates

• First Submitted: March 17, 2021
• First Submitted That Met QC Criteria: March 19, 2021
• First Posted (Actual): March 22, 2021

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 19, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2019-0943

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes