Microsampling Assays for Immunosuppressive Drugs in Children

NCT04989686 | Completed

• 2 other identifiers: 22-0204105R21HD106103-02
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immunosuppression

Keywords

microsampling; cyclosporine A; tacrolimus; sirolimus; Tasso-M20

Outcome Measures

Primary Outcomes (3)

• Clinical validation of microsampling assay of Tacrolimus

  Capillary whole blood specimens will be obtained via the Tasso M-20 sampling device to determine validity of the assay compared to venous blood samples (gold standard and used clinically) in measuring Tacrolimus concentration levels.

  up to 20 months

• Clinical validation of microsampling assay of Sirolimus

  Capillary whole blood specimens will be obtained via the Tasso M-20 sampling device to determine validity of the assay compared to venous blood samples (gold standard and used clinically) in measuring Sirolimus concentration levels.

  up to 20 months

• Clinical validation of microsampling assay of Cyclosporine A

  Capillary whole blood specimens will be obtained via the Tasso M-20 sampling device to determine validity of the assay compared to venous blood samples (gold standard and used clinically) in measuring Cyclosporin A concentration levels.

  up to 20 months

Secondary Outcomes (6)

• Stability of blood samples which contains immunosuppressive drug Tacrolimus under conditions of shipping

  up to 20 months

• Stability of blood samples obtained which contains immunosuppressive drug Sirolimus under conditions of shipping

  up to 20 months

• Stability of blood samples containing immunosuppressive drug Cyclosporine A under conditions of shipping

  up to 20 months

• Stability of blood samples which contains immunosuppressive drug Tacrolimus under conditions of storage

  up to 20 months

• Stability of blood samples which contains immunosuppressive drug Sirolimus under conditions of storage

  up to 20 months

Other Outcomes (2)

• Usability of the two methods of blood collection

  up to 20 months

• Acceptability of the two methods of blood collection

  up to 20 months

Study Arms (3)

Cyclosporine A

1. Males and females \<18 years of age 2. Weight greater than 5 kg 3. Receiving cyclosporine A as the standard of care 4. Has scheduled/anticipated blood draw to quantify the concentration of cyclosporine A for clinical indications 5. Parental/guardian permission (informed consent), and subject's assent if applicable.

Other: Microsampling

Tacrolimus

1. Males and females \<18 years of age 2. Weight greater than 5 kg 3. Receiving tacrolimus as the standard of care 4. Has scheduled/anticipated blood draw to quantify the concentration of tacrolimus for clinical indications 5. Parental/guardian permission (informed consent), and subject's assent if applicable.

Other: Microsampling

Sirolimus

1. Males and females \<18 years of age 2. Weight greater than 5 kg 3. Receiving sirolimus as the standard of care 4. Has scheduled/anticipated blood draw to quantify the concentration of sirolimus for clinical indications 5. Parental/guardian permission (informed consent), and subject's assent if applicable.

Other: Microsampling

Interventions

Microsampling OTHER

Volumetric absorptive microsampling (VAMS) with Tasso-M20 devices allows for the accurate and precise collection of a fixed small volume of blood from a capillary needle without the need for phlebotomy.

Cyclosporine A; Sirolimus; Tacrolimus

Eligibility Criteria

• Age: Up to 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children receiving immunosuppressive therapy and scheduled/anticipated blood draw to quantify the concentration of the immunosuppressive drugs (CYA, TAC, and SIR) for clinical indications.

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.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Hospital of Phildelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (24)

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  BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Investigators will plan to enroll up to 150 subjects to obtain 120 evaluable subjects (CYA: 40 subjects, SIR: 40 subjects, and TAC: 40 subjects). Two blood samples for up to five blood tests will be drawn simultaneously. 1. Sample Collection 1 will be obtained from venous or arterial blood. 1. Blood test 1: TDM measure of the immunosuppressive drug 2. Blood test 2: Hemoglobin/hematocrit measurement (if not obtained as the standard of care within 12 hours prior or simultaneous with TDM measure will be obtained as a research collection) 2. Sample collection 2 will be obtained from capillary blood through the Tasso-M20 device a. Blood test 3: Research indicated measurement of immunosuppressive drug concentration.

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 4, 2021
• Study Start: June 8, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2025
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)