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This non-interventional study intends to collect epidemiological data in patients with stable kidney function after renal transplantation, who receive Tacrolimus Sandoz© according to the approved indication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renal allograft |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| In this observational study no study specific intervention is planned | Other | Patients with stable kidney function who already receive Tacrolimus Sandoz© capsules before being included in this non-interventional study, are being observed for 6 months by their attending physicians. Routine medical treatment is provided. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Adport Sandoz© trough level | Observation time: 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of Adport Sandoz© in prevention of renal graft rejection by observing serum creatinine levels | Observation time: 26 weeks | |
| Incidence of serious adverse drug reactions | Observation time: 26 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Patients after renal transplantation who are treated in the general hospital of Vienna on an outpatient basis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital | Vienna | 1090 | Austria |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Retained types of biospecimen: whole blood, serum, urine
|
| Incidence of adverse drug reactions | Observation time: 26 weeks |
| Incidence of serious adverse events | Observation time: 26weeks |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |