Transplantation Drugs Stability
Conditions
Brief 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.
Interventions
PROCEDUREBlood sampling
Blood sampling from all eligible transplantation patients according to the protocol
Sponsors
ICON plc
Thermo Fisher Scientific Oy
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptance criteria for claiming the patient samples storage stability | 5 months | 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%. |
Countries
Italy
Outcome results
None listed