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

NCT05274308 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2022-10-07

No results posted yet for this study

Summary

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.

Conditions

  • Transplantation Drugs Stability

Interventions

PROCEDURE

Blood sampling

Blood sampling from all eligible transplantation patients according to the protocol

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Thermo Fisher Scientific Oy

    lead INDUSTRY

Principal Investigators

  • Sanna Anttonen · Thermo Fisher Scientific, Inc

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-07
Primary Completion
2022-07-26
Completion
2022-07-26

Countries

  • Italy

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05274308 on ClinicalTrials.gov