Generic Immunosuppressive Drugs After Lung Transplantation

• Conditions: Immunosuppressive After Lung Transplantation

• Registration Number: NCT01889017
• Lead Sponsor: Hannover Medical School

Brief Summary

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

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 Timeline

• Status Verified: 2013-06
• Study First Submitted: 2013-06-26
• Study First Submitted QC: 2013-06-26
• Study First Posted: 2013-06-28
• Study Start: 2013-07
• Last Update Submitted: 2013-07-15
• Last Update Posted: 2013-07-16
• Primary Completion: 2014-03
• Study Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of use of generic immunosuppressive drugs	baseline

Secondary Outcome Measures

Name	Time	Method
Calcineurin inhibitor through levels	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	baseline	Dose of calcineurin inhibitors between generic and original immunosuppressive drugs at questionnaire
Therapy adherence	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	baseline	Satisfaction with immunosuppression between generic and original immunosuppressive drugs will be measured by a 5-point Likert scale.

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hanover, Lower Saxony, Germany