Generic Immunosuppressive Drugs After Lung Transplantation

Hannover Medical School (MHH)

Status: Unknown

Conditions: Immunosuppressive After Lung Transplantation

Treatments: Other: patient questionnaire (tablet pc based)

Study type: Observational

Funder types: Other

Identifiers

NCT01889017

V 1.0 22/05/2013

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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