Microsampling Assays for Immunosuppressive Drugs in Children

Completed

Conditions studied: Immunosuppression

In brief

Immunosuppressive therapy is used to treat and manage solid organ and bone marrow/stem cell transplants in children. However, it can be harmful if too little or too much is given. Monitoring immunosuppressive drug (cyclosporine A, tacrolimus, and sirolimus) concentrations in the blood is important to ensure that the drug is given safely and effectively, but current approaches for collecting blood from a vein are painful and often difficult in children. Investigators seek to compare a new approach for monitoring immunosuppressive drug concentrations using a novel small volume blood sampling device, called Tasso-M20, to the traditional way of collecting blood from a vein. Additionally Investigators are interested in assessing patient and family perceptions of the Tasso-M20 device being used for immunosuppressive therapy and their comfortability using the device outside of a clinical setting. The primary objective of this project is to identify the relationship between cyclosporine A (CYA), tacrolimus (TAC), and sirolimus (SIR) concentrations in the venous blood (gold-standard) and capillary whole blood obtained using the microsampling device Tasso-M20. The secondary objective of this study is to investigate the stability of CYA, TAC, and SIR in blood samples collected using the Tasso-M20 device under the conditions of shipping and storage. The sub-study objective is to thematically compare subjects' and families' perceptions of blood collection via the Tasso-M20 device and standard venous blood collection.

Key facts

Study ID

NCT04989686

Run by

Children's Hospital of Philadelphia

People needed

66

Starts

2023-06-08

Expected to finish

2025-05-01

Last updated by the study team

2025-07-14

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females <18 years of age
• Weight greater than 5 kg
• Receiving CYA, TAC, and/or SIR as standard of care
• Has scheduled/anticipated blood draw to quantify the concentration of CYA, TAC, and SIR* for clinical indications
• Parental/guardian permission (informed consent), and subject's assent if applicable.

You may not qualify if…

• 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.

Where it is running

• Children's Hospital of Phildelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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