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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004121-33 | EudraCT Number |
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The purpose of this study is to assess relationship between tacrolimus concentrations determined via whole blood MITRA assay method with those determined using the established and validated whole blood venepuncture method using samples taken from liver and kidney transplant participants.
This will be a bioanalytical assay method cross-validation study using blood samples donated by liver or kidney transplant participants. Participants will have been on a stable dose of Advagraf and deemed clinically stable for a period of 3-6 months and attend a routine out-patient follow-up visit to receive their usual oral dose of commercial Advagraf. Participants will be asked to provide 1 whole blood venepuncture sample and 1 whole blood finger prick MITRA sample at pre-dose and at approximately 1 and 3 hours post-dose. Participants will be kept at the study site for an extra 1 hour to ensure post-sampling safety and will be discharged thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver or kidney transplant participants of Advagraf | Other | Transplant participants will provide 1 whole blood venepuncture sample and 1 whole blood finger prick MITRA sample at pre-dose of participant's usual oral dose of commercial Advagraf and at approximately 1 and 3 hours post-dose. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of blood concentrations of tacrolimus | Tacrolimus concentrations will be determined from the dried whole blood samples collected via finger prick into MITRA cartridge and in whole blood taken by venipuncture. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Research Physician | Astellas Pharma Europe Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site FR33002 | Toulouse | France | ||||
| Site FR33001 |
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| Villejuif |
| France |
| Site UK44002 | Cambridge | United Kingdom |
| Site UK44001 | London | United Kingdom |
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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