Immunosuppressive After Lung TransplantationNCT01889017
Generic Immunosuppressive Drugs After Lung Transplantation
An observational study of Immunosuppressive After Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
Trial summary
Extent of use of generics immunosuppressive drugs in clinical practice after lung transplantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunosuppressive After Lung Transplantation
- What is being tested?
- patient questionnaire (tablet pc based)
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2013to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients after lung transplantation (single, double or combined) with an immunosuppressive therapy with tacrolimus or ciclosporin
Who may be able to join
- patients after lung transplantation (single, double or combined)
- informed consent
- patient with an immunosuppressive therapy with tacrolimus or ciclosporin
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover, Lower Saxony, 30625
Imke Zinowsky, 0049-5115325841
Jens Gottlieb, MD
About this study
Official title: 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
Read the 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.
- Being tested
- patient questionnaire (tablet pc based)
- Keywords
- generic immunosuppressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient questionnaire (tablet pc based)Other
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of use of generic immunosuppressive drugs
Measured: baseline
Secondary outcomes (4)
Calcineurin inhibitor through levels
Frequency of calcineurin inhibitor through levels in target range between generic and original immunosuppressive drugs during last 6 months
Measured: baseline, retrospective 6 months
Dose of calcineurin inhibitors
Dose of calcineurin inhibitors between generic and original immunosuppressive drugs at questionnaire
Measured: baseline
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.
Measured: baseline
Satisfaction with immunosuppression
Satisfaction with immunosuppression between generic and original immunosuppressive drugs will be measured by a 5-point Likert scale.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immunosuppressive After Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Fuehner, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889017
- Sponsor's protocol ID
- V 1.0 22/05/2013
- Status last verified
- Jun 2013
- First submitted
- 26 Jun 2013
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Drick N, Seeliger B, Fuge J, Tudorache I, Greer M, Welte T, Haverich A, Gottlieb J. Self-reported non-adherence to immunosuppressive medication in adult lung transplant recipients-A single-center cross-sectional study. Clin Transplant. 2018 Apr;32(4):e13214. doi: 10.1111/ctr.13214. Epub 2018 Feb 23.
PubMed 29380445
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Generic Immunosuppressive Drugs After Lung Transplantation - a Crosssectional Observational Study by Patient Questionnaire
- ClinicalTrials.gov ID
- NCT01889017
- Acronym / sponsor ID
- V 1.0 22/05/2013
- Keywords
- generic immunosuppressive
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 28 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients after lung transplantation (single, double or combined) with an immunosuppressive therapy with tacrolimus or ciclosporin
Key inclusion criteria (3 listed)
- patients after lung transplantation (single, double or combined)
- informed consent
- patient with an immunosuppressive therapy with tacrolimus or ciclosporin
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient questionnaire (tablet pc based) | Other | – |
Primary outcome
Frequency of use of generic immunosuppressive drugs
Time frame: baseline
4 secondary outcomes
Calcineurin inhibitor through levels
Time frame: baseline, retrospective 6 months
Dose of calcineurin inhibitors
Time frame: baseline
Therapy adherence
Time frame: baseline
Satisfaction with immunosuppression
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2013.
- Derived from this study: PubMed 29380445Drick N, Seeliger B, Fuge J, Tudorache I, Greer M, Welte T, Haverich A, Gottlieb J. Self-reported non-adherence to immunosuppressive medication in adult lung transplant recipients-A single-center cross-sectional study. Clin Transplant. 2018 Apr;32(4):e13214. doi: 10.1111/ctr.13214. Epub 2018 Feb 23.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunosuppressive After Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jens Gottlieb, MD (0049511-532 ext. 4601, gottlieb.jens@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of use of generic immunosuppressive drugs (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01889017, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2013.