Generic Immunosuppressive Drugs After Lung Transplantation
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|ClinicalTrials.gov Identifier: NCT01889017|
Recruitment Status : Unknown
Verified June 2013 by Thomas Fuehner, Hannover Medical School.
Recruitment status was: Recruiting
First Posted : June 28, 2013
Last Update Posted : July 16, 2013
|Condition or disease||Intervention/treatment|
|Immunosuppressive After Lung Transplantation||Other: patient questionnaire (tablet pc based)|
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.
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||Generic Immunosuppressive Drugs After Lung Transplantation - a Crosssectional Observational Study by Patient Questionnaire|
|Study Start Date :||July 2013|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||September 2014|
- Frequency of use of generic immunosuppressive drugs [ Time Frame: baseline ]
- Calcineurin inhibitor through levels [ Time Frame: baseline, retrospective 6 months ]Frequency of calcineurin inhibitor through levels in target range between generic and original immunosuppressive drugs during last 6 months
- Dose of calcineurin inhibitors [ Time Frame: baseline ]Dose of calcineurin inhibitors between generic and original immunosuppressive drugs at questionnaire
- Therapy adherence [ Time Frame: baseline ]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.
- Satisfaction with immunosuppression [ Time Frame: baseline ]Satisfaction with immunosuppression between generic and original immunosuppressive drugs will be measured by a 5-point Likert scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01889017
|Contact: Jens Gottlieb, MD||0049511-532 ext firstname.lastname@example.org|
|Contact: Imke Zinowsky||0049511-532 ext email@example.com|
|Hannover Medical School||Recruiting|
|Hanover, Lower Saxony, Germany, 30625|
|Contact: Imke Zinowsky 0049-5115325841|
|Principal Investigator: Jens Gottlieb, MD|
|Sub-Investigator: Mark Greer, MB|
|Sub-Investigator: Felix Ringshausen, MD|