Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples

Cascadion™ SM Immunosuppressants Panel, Stability of Tacrolimus, Cyclosporine A, Everolimus and Sirolimus in Whole Blood Patient Samples

This is a prospective, observational evaluation study to assess the stability of the analytes tacrolimus, cyclosporine A, everolimus and sirolimus measured with Cascadion™ SM Immunosuppressants Panel. Study is pre-market evaluation for the regions where Cascadion™ SM Immunosuppressants Panel is not on the market yet and post-market evaluation where it is.

To assess the stability of tacrolimus, cyclosporine A, everolimus and sirolimus in patient whole blood samples after they are collected, processed and subjected to various storage conditions or freeze-thaw cycles that represent common sample handling conditions in the commercial clinical laboratory setting.

Study subjects will undergo one venous sample collection where 30 mL of blood is drawn.

Study Overview

• Status: Completed
• Conditions: Transplantation Drugs Stability
• Intervention / Treatment: Procedure: Blood sampling

• Study Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Italy
  • Turin, Italy, 10126
    • AOU Città della Salute e della Scienza di Torino/S.C Biochimica Clinica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subject's using following immunosuppressants drugs accordingly with organ transplantation

1. Kidney, liver or heart transplant patient using tacrolimus or cyclosporine A
2. Kidney or liver transplant patient using everolimus
3. Kidney transplant patient using sirolimus

Description

Inclusion Criteria:

1. Age ≥18 years
2. Ability to sign informed consent form

3. At least one of the following

   1. Kidney, liver or heart transplant patient using tacrolimus or cyclosporine A
   2. Kidney or liver transplant patient using everolimus
   3. Kidney transplant patient using sirolimus

Exclusion Criteria:

1. Inability to provide informed consent
2. Pregnancy or breastfeeding
3. Likely to believe that the sample collection procedure will pose an unusually high risk for subject's physical or mental health or their comfort

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient blood sample collection; 30 mL of whole blood collected from eligible patients in one sampling	Procedure: Blood sampling; Blood sampling from all eligible transplantation patients according to the protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance criteria for claiming the patient samples storage stability	Stability of cyclosporine A, tacrolimus, everolimus and sirolimus in patient whole blood samples will be tested at +15-25°C up to 4 days, at +2-8°C up to 15 days and at -20±5°C up to 31 days. Relative bias at each time point to T0 baseline is calculated for each patient sample separately. The grand average relative bias across all samples, and the associated 95% confidence interval, must be within -15% and +15%.	5 months

Collaborators and Investigators

• Sponsor: Thermo Fisher Scientific Oy
• Collaborators: ICON plc
• Investigators: Study Director: Sanna Anttonen, Thermo Fisher Scientific, Inc

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2022
• Primary Completion (Actual): July 26, 2022
• Study Completion (Actual): July 26, 2022

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CA1803-STSS-PRO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No