Lung TransplantationPhase 3NCT00930241
Twice Daily Versus Once Daily Administration of the Tacrolimus in Lung Transplantation
A Phase 3 study testing Advagraf® and Prograf® in people with Lung Transplantation, run by Hannover Medical School at 3 sites in Germany.
Trial summary
This study is a prospective randomized trial to compare twice daily to once daily administration of the basic immunosuppressive regimen in lung transplanted patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Advagraf® and Prograf®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesGermany
- Study dates
- Jul 2009to Jul 2012
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (Pts) more than 1 year after single lung, double lung or heart/lung transplantation
- Pts treated with cyclosporin, steroids and MMF
- Pts ≥ 18 and ≤ 70 years and
- Pts with one of the following:
- pts with recurrent acute rejections (RAR)
- two or more acute rejections in 3 months (first 3 years post Tx, 6 months (> 3 years post Tx) defined by:
Show all 13Show fewer
- transbronchial biopsy > A1 (or A1 with clinical criteria below) nach ISHLT (B>1R) or
- decline of FEV1 > 10 % baseline after exclusion of infection, airway complication, effusion etc. and improvement to steroid-pulse therapy (methylprednisolone 15 mg/kg for three days) = FEV1 improvement > 10% compared to the last measurement before AR treatment
- Pts with steroid-resistant or ongoing acute rejections (OAR) defined by:
- transbronchial biopsy > A1 (or A1 with clinical criteria above) at least 4 weeks following steroid-pulse therapy (methylprednisolone 15 mg/kg for three days) or
- no FEV1 improvement (< 5% baseline) at least 14 days following ACR steroid-pulse therapy (methylprednisolone 15 mg/kg for three days) after exclusion of infection, airway complication, effusion etc. or
- Pts with new onset of BOS (nBOS) Unexplained FEV1 < 80% of baseline after exclusion of Infection, airway complication, effusion etc
- Pts with CyA associated side effects (e.g., hyperlipidaemia, hypertriglyceridemia, hypertension, hirsutism, gingival hyperplasia)
Who cannot join
- Pregnant or breast feeding women
- Pts who are not using a double-barrier method of birth control
- Pts with systemic infections
- Pts with severe diarrhea, vomiting, active ulcer
- Pts with severe liver disease or liver cirrhosis
- Pts with m-Tor inhibitors
- Pts with hypersensitivity to Tacrolimus, other macrolides or other tablet ingredients
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Department of Respiratory Medicine, Medizinische Hochschule Hannover
Hanover, 30625
Hannover Medical School, Dept. of Respiratory Medicine
Hanover, 30625
Hannover Medical School
Hanover, 30625
About this study
Official title: Prospective Randomized Trial to Compare a Twice Daily to a Once Daily Administration of the Tacrolimus in Lung Transplanted Patients
This study is a prospective randomized trial to compare twice daily to once daily administration of the basic immunosuppressive regimen in lung transplanted patients.
Read the detailed description
Prevalence data of non-compliance in solid organ transplantations fluctuate is reported in up to 39% of transplant recipients (z. B. for lung transplantations 13 - 22%; Kugler et al.). Non-compliance with immunosuppressive therapy is associated with an increased risk of late-acute rejections and the development of chronic transplant dysfunction. Chronic transplant dysfunction (bronchiolitis obliterans- syndrome-BOS) is the second most causing for organ failure after the first year following lung transplantation and often leads to re-transplantation or death. Preventative procedures for improving the compliance are simplification of the dose of the immunosuppressants (a once daily dose instead of a twice daily dose), the prescription of an immunosuppressants with less side-effects and to raise the patient´s awareness for having the greatest responsibility for the efficacy of his therapy. Prospective studies and metaanalysis revealed that the probability for a good compliance can be more than doubled at once daily administration in comparison to twice daily and the best predictor for a good compliance is an easy therapy. For this reason we want to investigate the extent of profit for our lung transplant patients receiving once daily basis immunosuppression in comparison to those who receive twice daily dose.
Hypothesis: Patients of the once daily administration group of the immunosuppressive medication will have a better compliance compared to the twice daily group (as measured by the endpoints variability and medication abstraction from the electronic devices)
- Conditions
- Lung Transplantation
- Being tested
- Advagraf®, Prograf®
- Keywords
- Lung Transplantation, Tacrolimus, Deterioration of graft function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advagraf®Drug
Advagraf® (one daily dose of Tacrolimus)
Prograf®Drug
Prograf® (two daily doses of Tacrolimus)
| Study group | Role | What they receive |
|---|---|---|
| Advagraf | Experimental | Advagraf® (one daily dose of Tacrolimus) Receives: Drug: Advagraf® |
| Prograf | Active comparator | Prograf® (two daily doses of Tacrolimus) Receives: Drug: Prograf® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of adherence as measured by Tacrolimus trough level below the target level and dispensing of less than 50% of the prescribed doses in the last three days measured electronically before this subtherapeutic drug monitoring
Measured: 6 months
Secondary outcomes (2)
Deterioration of graft function (FEV1) before and at month 12 after conversion
Measured: 6 months
Number of drug holidays (intake of less than 50% of prescribed doses in 24 hours) measured electronically
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJul 2009
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: logistic reasons (insufficient funding, technical problems with MEMS)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens T Gottlieb, M.D., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00930241
- Sponsor's protocol ID
- 5281M mono
- Status last verified
- Aug 2018
- First submitted
- 29 Jun 2009
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial to Compare a Twice Daily to a Once Daily Administration of the Tacrolimus in Lung Transplanted Patients
- ClinicalTrials.gov ID
- NCT00930241
- Acronym / sponsor ID
- 5281M mono
- Conditions
- Lung Transplantation
- Keywords
- Lung Transplantation, Tacrolimus, Deterioration of graft function
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: logistic reasons (insufficient funding, technical problems with MEMS)
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 30 Jun 2009 (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.
This study is a prospective randomized trial to compare twice daily to once daily administration of the basic immunosuppressive regimen in lung transplanted patients.
Detailed description
Prevalence data of non-compliance in solid organ transplantations fluctuate is reported in up to 39% of transplant recipients (z. B. for lung transplantations 13 - 22%; Kugler et al.). Non-compliance with immunosuppressive therapy is associated with an increased risk of late-acute rejections and the development of chronic transplant dysfunction. Chronic transplant dysfunction (bronchiolitis obliterans- syndrome-BOS) is the second most causing for organ failure after the first year following lung transplantation and often leads to re-transplantation or death. Preventative procedures for improving the compliance are simplification of the dose of the immunosuppressants (a once daily dose instead of a twice daily dose), the prescription of an immunosuppressants with less side-effects and to raise the patient´s awareness for having the greatest responsibility for the efficacy of his therapy. Prospective studies and metaanalysis revealed that the probability for a good compliance can be more than doubled at once daily administration in comparison to twice daily and the best predictor for a good compliance is an easy therapy. For this reason we want to investigate the extent of profit for our lung transplant patients receiving once daily basis immunosuppression in comparison to those who receive twice daily dose.
Hypothesis: Patients of the once daily administration group of the immunosuppressive medication will have a better compliance compared to the twice daily group (as measured by the endpoints variability and medication abstraction from the electronic devices)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Advagraf | Experimental | Drug: Advagraf®Advagraf® (one daily dose of Tacrolimus) |
| Prograf | Active comparator | Drug: Prograf®Prograf® (two daily doses of Tacrolimus) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients (Pts) more than 1 year after single lung, double lung or heart/lung transplantation
- Pts treated with cyclosporin, steroids and MMF
- Pts ≥ 18 and ≤ 70 years and
- Pts with one of the following:
- Pts with steroid-resistant or ongoing acute rejections (OAR) defined by:
Key exclusion criteria (7 listed)
- Pregnant or breast feeding women
- Pts who are not using a double-barrier method of birth control
- Pts with systemic infections
- Pts with severe diarrhea, vomiting, active ulcer
- Pts with severe liver disease or liver cirrhosis
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 |
|---|---|---|
| Advagraf®Advagraf® (one daily dose of Tacrolimus) | Drug | Advagraf |
| Prograf®Prograf® (two daily doses of Tacrolimus) | Drug | Prograf |
Primary outcome
Improvement of adherence as measured by Tacrolimus trough level below the target level and dispensing of less than 50% of the prescribed doses in the last three days measured electronically before this subtherapeutic drug monitoring
Time frame: 6 months
2 secondary outcomes
Deterioration of graft function (FEV1) before and at month 12 after conversion
Time frame: 6 months
Number of drug holidays (intake of less than 50% of prescribed doses in 24 hours) measured electronically
Time frame: 6 months
Results and safety
The study was stopped early (reason given: logistic reasons (insufficient funding, technical problems with MEMS)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
Related trials for Lung Transplantation
RecruitingPhase 1
Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies
Lung Transplantation
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
Active, not recruitingPhase 1/2
Alvelestat (MPH966), an Oral Neutrophil Elastase Inhibitor, in Bronchiolitis Obliterans Syndrome After Allogeneic Hematopoietic Stem Cell Transplantation
Chronic Graft vs Host Disease, Chronic Graft-Versus-Host Disease
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
RecruitingObservational study
Trifecta-Lung cfDNA-MMDx Study
Lung Transplantation
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.
Jens T Gottlieb, M.D. principal investigator
Hannover Medical School
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Advagraf® and Prograf® in people with Lung Transplantation, run by Hannover Medical School at 3 sites 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 13 inclusion and 7 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: stopped early, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: logistic reasons (insufficient funding, technical problems with MEMS)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of adherence as measured by Tacrolimus trough level below the target level and dispensing of less than 50% of the prescribed doses in the last three days measured electronically before this subtherapeutic drug monitoring (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2018.