Generic Immunosuppressive Drugs After Lung Transplantation

Immunosuppressive After Lung Transplantation Clinical Trial

Official title:

Generic Immunosuppressive Drugs After Lung Transplantation - a Crosssectional Observational Study by Patient Questionnaire

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01889017
• Other study ID #: V 1.0 22/05/2013
• Status: Recruiting
• Phase: N/A
• First received: June 26, 2013
• Last updated: July 15, 2013
• Start date: July 2013
• Est. completion date: September 2014

Study information

• Verified date: June 2013
• Source: Hannover Medical School
• Contact: Jens Gottlieb, MD
• Phone: 0049511-532
• Email: gottlieb.jens[@]mh-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Immunosuppressive After Lung Transplantation

Intervention

Other:
• patient questionnaire (tablet pc based)

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hanover	Lower Saxony

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of use of generic immunosuppressive drugs		baseline	No
Secondary	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	Yes
Secondary	Dose of calcineurin inhibitors	Dose of calcineurin inhibitors between generic and original immunosuppressive drugs at questionnaire	baseline	No
Secondary	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	No
Secondary	Satisfaction with immunosuppression	Satisfaction with immunosuppression between generic and original immunosuppressive drugs will be measured by a 5-point Likert scale.	baseline	No