Lung TransplantationPhase 3NCT00402532
Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation
A Phase 3 study testing Everolimus and Mycophenolatmofetil in people with Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether Everolimus is effective in the treatment and prevention of chronic graft dysfunction and chronic graft rejection after lung transplantation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Everolimus and Mycophenolatmofetil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2005to Dec 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipient of Single or Bilateral Lung Transplantation
- Informed consent
- Recipients who are able to receive Everolimus at week 3 after Lung Transplantation
- women of childbearing potential must have a negative pregnancy test within 48 hours of enrolment
- women of childbearing potential must use appropriate contraceptive method at enrolment, during the study and up to 8 weeks after the end of the study
- donor must not have relevant pulmonary diseases
- donor must have oxygen partial pressure higher than 300 mmHg at FiO 1.0 and positive end-expiratory pressure of 5 cm H2O.
Who cannot join
- systemic infection of the donor
- donor: signs or symptoms of aspiration
- donor: severe pulmonary injury or contusion
- donor: malignant neoplasm of the lung
- donor: HIV positive
- recipients who receive immunosuppressive agents not used in this protocol
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- recipients who participated within 30 days before study start or are currently participating in another investigational drug trial
- HIV positive recipient
- systemic infection of the recipient
- recipients of combined/ multiple transplantations
- pregnancy of the recipient
- recipients with signs/ Symptoms of impaired wound healing of the pulmonary anastomoses
- recipients who are still on artificial respiration or who are not able to swallow tablets at week 3 after transplantation
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hannover Medical School, Division of Thoracic and Cardiovascular Surgery
Hanover, 30625
About this study
The purpose of this study is to determine whether Everolimus is effective in the treatment and prevention of chronic graft dysfunction and chronic graft rejection after lung transplantation.
- Conditions
- Lung Transplantation
- Being tested
- Everolimus, Mycophenolatmofetil
- Keywords
- Lung Transplantation, Immunosuppression, Mortality, Graft rejection, Bronchiolitis obliterans, Opportunistic infections, Nephrotoxicity
- Medical subject headings
- Bronchiolitis Obliterans, Opportunistic Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EverolimusDrug
Also called Certican
Initial dosage 2 x 0.75 mg/d
MycophenolatmofetilDrug
Also called Cellcept
Initial dosage 2 x 500 mg/d intravenous
| Study group | Role | What they receive |
|---|---|---|
| Everolimus | Active comparator | Not described Receives: Drug: Everolimus |
| Mycophenolatmofetil | Active comparator | Not described Receives: Drug: Mycophenolatmofetil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation
Measured: 2 years
Secondary outcomes (2)
Incidence and severity of Nephrotoxicity within 2 years of transplantation
Measured: 2 years
Incidence and severity of opportunistic infections within 2 years of transplantation
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startMar 2005
- Primary completionNov 2011
- Study completionDec 2011
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Responsible party
- Principal investigator, Martin Strueber, Hannover Medical School
- Investigators
- Martin Strueber, Dr., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402532
- Sponsor's protocol ID
- Ever-Lung-DE01/RAD-LungDE01
- Status last verified
- Dec 2011
- First submitted
- 20 Nov 2006
- Last updated
- 8 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation
- ClinicalTrials.gov ID
- NCT00402532
- Acronym / sponsor ID
- Ever-Lung-DE01/RAD-LungDE01
- Conditions
- Lung Transplantation
- Keywords
- Lung Transplantation, Immunosuppression, Mortality, Graft rejection, Bronchiolitis obliterans, Opportunistic infections, Nephrotoxicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Novartis Pharmaceuticals
- Study start
- Mar 2005
- Primary completion
- Nov 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 22 Nov 2006 (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.
The purpose of this study is to determine whether Everolimus is effective in the treatment and prevention of chronic graft dysfunction and chronic graft rejection after lung transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Everolimus | Active comparator | Drug: Everolimus |
| Mycophenolatmofetil | Active comparator | Drug: Mycophenolatmofetil |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Recipient of Single or Bilateral Lung Transplantation
- Informed consent
- Recipients who are able to receive Everolimus at week 3 after Lung Transplantation
- women of childbearing potential must have a negative pregnancy test within 48 hours of enrolment
- women of childbearing potential must use appropriate contraceptive method at enrolment, during the study and up to 8 weeks after the end of the study
Key exclusion criteria (13 listed)
- systemic infection of the donor
- donor: signs or symptoms of aspiration
- donor: severe pulmonary injury or contusion
- donor: malignant neoplasm of the lung
- donor: HIV positive
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 |
|---|---|---|
| EverolimusAlso: CerticanInitial dosage 2 x 0.75 mg/d | Drug | Everolimus |
| MycophenolatmofetilAlso: CellceptInitial dosage 2 x 500 mg/d intravenous | Drug | Mycophenolatmofetil |
Primary outcome
Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation
Time frame: 2 years
2 secondary outcomes
Incidence and severity of Nephrotoxicity within 2 years of transplantation
Time frame: 2 years
Incidence and severity of opportunistic infections within 2 years of transplantation
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2011.
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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.
Martin Strueber, Dr. principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Everolimus and Mycophenolatmofetil in people with 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 7 inclusion and 13 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: finished, as of the sponsor's last update on 8 Dec 2011. 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation (time frame: 2 years). 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 8 Dec 2011.