Generic Immunosuppressive Drugs After Lung Transplantation

July 15, 2013 updated by: Thomas Fuehner, Hannover Medical School

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Lower Saxony
      • Hanover, Lower Saxony, Germany, 30625
        • Recruiting
        • Hannover Medical School
        • Contact:
          • Imke Zinowsky
          • Phone Number: 0049-5115325841
        • Principal Investigator:
          • Jens Gottlieb, MD
        • Sub-Investigator:
          • Mark Greer, MB
        • Sub-Investigator:
          • Felix Ringshausen, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency of use of generic immunosuppressive drugs
Time Frame: baseline
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline, retrospective 6 months
Dose of calcineurin inhibitors
Time Frame: baseline
Dose of calcineurin inhibitors between generic and original immunosuppressive drugs at questionnaire
baseline
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.
baseline
Satisfaction with immunosuppression
Time Frame: baseline
Satisfaction with immunosuppression between generic and original immunosuppressive drugs will be measured by a 5-point Likert scale.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

September 1, 2014

Study Registration Dates

First Submitted

June 26, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (Estimate)

June 28, 2013

Study Record Updates

Last Update Posted (Estimate)

July 16, 2013

Last Update Submitted That Met QC Criteria

July 15, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • V 1.0 22/05/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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