ClinicalTrials.gov
ClinicalTrials.gov Menu

Generic Immunosuppressive Drugs After Lung Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):
Thomas Fuehner, Hannover Medical School

Brief Summary:
Extent of use of generics immunosuppressive drugs in clinical practice after lung transplantation

Condition or disease Intervention/treatment
Immunosuppressive After Lung Transplantation Other: patient questionnaire (tablet pc based)

Detailed Description:

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
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Frequency of use of generic immunosuppressive drugs [ Time Frame: baseline ]

Secondary Outcome Measures :
  1. 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

  2. Dose of calcineurin inhibitors [ Time Frame: baseline ]
    Dose of calcineurin inhibitors between generic and original immunosuppressive drugs at questionnaire

  3. 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.

  4. Satisfaction with immunosuppression [ Time Frame: baseline ]
    Satisfaction with immunosuppression between generic and original immunosuppressive drugs will be measured by a 5-point Likert scale.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients after lung transplantation (single, double or combined) with an immunosuppressive therapy with tacrolimus or ciclosporin
Criteria

Inclusion Criteria:

  • patients after lung transplantation (single, double or combined)
  • informed consent
  • patient with an immunosuppressive therapy with tacrolimus or ciclosporin

Exclusion Criteria:

  • immunosuppressive therapy without calcineurin inhibitors
  • need for isolation (Colonization with multi. or pan resistant organisms e.g. methicillin-resistant staph. aureus[MRSA), B. cenocepacia)
  • limited German language skills or other reasons which might impair patient communication or computer handling

Information from the National Library of Medicine

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


Contacts
Contact: Jens Gottlieb, MD 0049511-532 ext 4601 gottlieb.jens@mh-hannover.de
Contact: Imke Zinowsky 0049511-532 ext 5841 zinowsky.imke@mh-hannover.de

Locations
Germany
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         
Sponsors and Collaborators
Hannover Medical School

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Fuehner, MD, Hannover Medical School
ClinicalTrials.gov Identifier: NCT01889017     History of Changes
Other Study ID Numbers: V 1.0 22/05/2013
First Posted: June 28, 2013    Key Record Dates
Last Update Posted: July 16, 2013
Last Verified: June 2013

Keywords provided by Thomas Fuehner, Hannover Medical School:
generic immunosuppressive

Additional relevant MeSH terms:
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs