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Extent of use of generics immunosuppressive drugs in clinical practice after lung transplantation
Solid organ transplant recipients are treated with immunosuppressive drugs to prevent rejection of their grafts. The most frequently important maintenance immunosuppressive drugs in Europe are calcineurin inhibitors.
For a number of these compounds drug patents have expired in recent years and generic formulations have entered the market. There is considerable debate regarding the efficacy and safety of generic drug substitution in solid organ recipients.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patient questionnaire (tablet pc based) | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of use of generic immunosuppressive drugs | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Calcineurin inhibitor through levels | Frequency of calcineurin inhibitor through levels in target range between generic and original immunosuppressive drugs during last 6 months | baseline, retrospective 6 months |
| Dose of calcineurin inhibitors |
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Inclusion Criteria:
Exclusion Criteria:
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patients after lung transplantation (single, double or combined) with an immunosuppressive therapy with tacrolimus or ciclosporin
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jens Gottlieb, MD | Contact | 0049511-532 | 4601 | gottlieb.jens@mh-hannover.de |
| Imke Zinowsky | Contact | 0049511-532 | 5841 | zinowsky.imke@mh-hannover.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School | Recruiting | Hanover | Lower Saxony | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29380445 | Derived | Drick N, Seeliger B, Fuge J, Tudorache I, Greer M, Welte T, Haverich A, Gottlieb J. Self-reported non-adherence to immunosuppressive medication in adult lung transplant recipients-A single-center cross-sectional study. Clin Transplant. 2018 Apr;32(4):e13214. doi: 10.1111/ctr.13214. Epub 2018 Feb 23. |
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Dose of calcineurin inhibitors between generic and original immunosuppressive drugs at questionnaire
| baseline |
| Therapy adherence | Therapy adherence between generic and original immunosuppressive drugs. Adherence will be measured by a 5 item Likert scale covering self-monitoring, generla health perception, contacts, nutrition/exercise compliance and adherence to immunosuppression. | baseline |
| Satisfaction with immunosuppression | Satisfaction with immunosuppression between generic and original immunosuppressive drugs will be measured by a 5-point Likert scale. | baseline |