Generic Immunosuppressive Drugs After Lung Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Bayesian Dose Adjustment of Immunosuppressants After Lung Transplantation

NCT00975663

Lung and Heart-lung Transplantation

TERMINATED PHASE4

Comparing Efficacy & Safety of Tacrolimus & MMF With/Without Induction in the Elderly Following Kidney Transplantation.

NCT00296309

Kidney Transplantation

COMPLETED PHASE3

Immune Status in Solid Organ Transplantation

NCT01070901

Organ Transplants

COMPLETED

Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation

NCT00402532

Lung Transplantation

COMPLETED PHASE3

Pilot Study of Immunosuppression Drug Weaning in Liver Recipients Exhibiting Biomarkers of High Likelihood of Tolerance

NCT01445236

Liver Transplantation

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immunosuppressive After Lung Transplantation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

patient questionnaire (tablet pc based)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No