Tacrolimus Microsampling

Not Applicable

Completed

• Conditions: Validate Volumetric Absorptive Microsampling (VAMS) Assay

• Registration Number: NCT04810143
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-07
• Study First Submitted: 2021-03-17
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-22
• Primary Completion: 2022-01-03
• Study Completion: 2022-07-28
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-19
• Last Update Posted: 2022-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cincinnati Children's Hospital; 🇺🇸 Cincinnati, Ohio, United States