Microsampling Assays for Immunosuppressive Drugs in Children

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Jul 26, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new way to monitor medications used in children who have received organ or stem cell transplants. The medications being studied—cyclosporine A, tacrolimus, and sirolimus—help prevent the body from rejecting the new organ or cells, but it’s important to get the right amount. Too much or too little can be harmful. The trial is comparing a new device called Tasso-M20, which takes a small drop of blood from the skin, to the traditional method of drawing blood from a vein, which can be painful for children.

To participate in the study, children under 18 years old must weigh more than 5 kg and be receiving one of these medications as part of their treatment. They should also have a scheduled blood draw for testing. Parents or guardians will need to give permission for their child to join. Throughout the study, families will share their thoughts on using the Tasso-M20 device compared to regular blood draws, helping researchers understand which method is more comfortable and effective for kids.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Males and females \<18 years of age
• • 2. Weight greater than 5 kg
• • 3. Receiving CYA, TAC, and/or SIR as standard of care
• • 4. Has scheduled/anticipated blood draw to quantify the concentration of CYA, TAC, and SIR\* for clinical indications
• • 5. Parental/guardian permission (informed consent), and subject's assent if applicable.
• Exclusion Criteria:
• • 1) Unable to provide blood samples.
• • \* Potential subjects and their parents/guardians may be approached prior to having a blood draw scheduled if they meet all other eligibility criteria.
• Sub-Study Criteria:
• • Sub-study criteria for child participants will not differ from the main study. Adult participants are required to be a parent/legal guardian of a study subject.