Lung TransplantationPhase 3CsA PoumonNCT02876250
Postconditioning by Cyclosporin A in Pulmonary Transplantation
A Phase 3 study testing Cyclosporine A in people with Lung Transplantation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The morbidity and mortality of patients undergoing lung transplantation in the acute phase following surgical intervention is mainly due to the primary graft failure (PGF). The occurrence of PGF is multi factorial but is mainly caused by ischemia-reperfusion injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- Cyclosporine A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Sep 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients over 18 years old, man or woman, who are listed for pulmonary transplantation either mono or double lung transplantation.
Who cannot join
- No contra-indication to CsA administration.
Trial locations and contacts
1 site in 1 country.
About this study
The morbidity and mortality of patients undergoing lung transplantation in the acute phase following surgical intervention is mainly due to the primary graft failure (PGF).
The occurrence of PGF is multi factorial but is mainly caused by ischemia-reperfusion injury. The pulmonary graft suffers two periods of ischemia one when it is explanted from the donor (cold ischemia) followed by another when it is grafted into the recipient's thoracic cavity (warm ischemia). The brutal reperfusion of the graft exposes it to reperfusion injury that causes PGF. PGF occurs in up to 20% of transplanted patients and is associated with significantly higher levels of 30-days all-cause mortality. Patients with PGF have a 40% mortality at 30-days versus a 6% mortality in patients without PGF.
Read more
Ischemic postconditioning, has recently been described in experimental models of ischemia-reperfusion injury in the heart, and although not yet fully understood. Several studies suggest that the mitochondria play a central role in cellular survival mechanisms after a prolonged period of ischemia-reperfusion (with the mitochondrial permeability transition pore (mPTP)).
Experimental studies have shown that cyclosporin A (CsA) administered prior to reperfusion binds to cyclophilin D and blocks the opening of mPTP after reperfusion. This protective effect of ischemia-reperfusion injury by CsA has been shown in experimental studies and in clinical phase II trials in reperfused myocardial infarction patients.
The hypothesis of this study is that the administration of CsA in transplanted patients (before re-opening of the first pulmonary graft vessels) protects the transplanted lung(s) from the deleterious effects of ischemia-reperfusion injury and thus reduce the frequency and severity of PGF.
- Conditions
- Lung Transplantation
- Being tested
- Cyclosporine A, Placebo
- Keywords
- Lung transplantation, Cyclosporine, Postconditioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine ADrug
a pharmacological postconditioned group with IV administration of 2.5 mg/kg of CsA prior to first graft reperfusion
PlaceboDrug
a control group with IV administration of 2.5 mg/kg of placebo prior to first graft reperfusion
| Study group | Role | What they receive |
|---|---|---|
| Cyclosporine A | Experimental | a pharmacological postconditioned group with IV administration of 2.5 mg/kg of CsA prior to first graft reperfusion Receives: Drug: Cyclosporine A |
| Control | Placebo comparator | a control group with IV administration of 2.5 mg/kg of placebo prior to first graft reperfusion Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen)
Measured: 2 hours post-lung transplantation
PaO2/FiO2 ratio
Measured: 6 hours post-lung transplantation
PaO2/FiO2 ratio
Measured: 12 hours post-lung transplantation
PaO2/FiO2 ratio
Measured: 18 hours post-lung transplantation
PaO2/FiO2 ratio
Measured: 24 hours post-lung transplantation
PaO2/FiO2 ratio
Measured: 36 hours post-lung transplantation
PaO2/FiO2 ratio
Measured: 48 hours post-lung transplantation
PaO2/FiO2 ratio
Measured: 60 hours post-lung transplantation
PaO2/FiO2 ratio
Measured: 72 hours post-lung transplantation
Secondary outcomes (1)
primary graft failure grade
clinical status of primary graft failure at 72 hours
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionSep 2018 (estimated)
- Study completionSep 2018 (estimated)
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.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François TRONC, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876250
- Sponsor's protocol ID
- 2013-816
- Acronym
- CsA Poumon
- Status last verified
- Mar 2019
- First submitted
- 18 Aug 2016
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postconditioning by Cyclosporin A in Pulmonary Transplantation
- ClinicalTrials.gov ID
- NCT02876250
- Acronym / sponsor ID
- CsA Poumon / 2013-816
- Conditions
- Lung Transplantation
- Keywords
- Lung transplantation, Cyclosporine, Postconditioning
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 23 Aug 2016 (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 morbidity and mortality of patients undergoing lung transplantation in the acute phase following surgical intervention is mainly due to the primary graft failure (PGF).
The occurrence of PGF is multi factorial but is mainly caused by ischemia-reperfusion injury. The pulmonary graft suffers two periods of ischemia one when it is explanted from the donor (cold ischemia) followed by another when it is grafted into the recipient's thoracic cavity (warm ischemia). The brutal reperfusion of the graft exposes it to reperfusion injury that causes PGF. PGF occurs in up to 20% of transplanted patients and is associated with significantly higher levels of 30-days all-cause mortality. Patients with PGF have a 40% mortality at 30-days versus a 6% mortality in patients without PGF.
Ischemic postconditioning, has recently been described in experimental models of ischemia-reperfusion injury in the heart, and although not yet fully understood. Several studies suggest that the mitochondria play a central role in cellular survival mechanisms after a prolonged period of ischemia-reperfusion (with the mitochondrial permeability transition pore (mPTP)).
Experimental studies have shown that cyclosporin A (CsA) administered prior to reperfusion binds to cyclophilin D and blocks the opening of mPTP after reperfusion. This protective effect of ischemia-reperfusion injury by CsA has been shown in experimental studies and in clinical phase II trials in reperfused myocardial infarction patients.
The hypothesis of this study is that the administration of CsA in transplanted patients (before re-opening of the first pulmonary graft vessels) protects the transplanted lung(s) from the deleterious effects of ischemia-reperfusion injury and thus reduce the frequency and severity of PGF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cyclosporine A | Experimental | Drug: Cyclosporine Aa pharmacological postconditioned group with IV administration of 2.5 mg/kg of CsA prior to first graft reperfusion |
| Control | Placebo comparator | Drug: Placeboa control group with IV administration of 2.5 mg/kg of placebo prior to first graft reperfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients over 18 years old, man or woman, who are listed for pulmonary transplantation either mono or double lung transplantation.
Key exclusion criteria (1 listed)
- No contra-indication to CsA administration.
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 |
|---|---|---|
| Cyclosporine Aa pharmacological postconditioned group with IV administration of 2.5 mg/kg of CsA prior to first graft reperfusion | Drug | Cyclosporine A |
| Placeboa control group with IV administration of 2.5 mg/kg of placebo prior to first graft reperfusion | Drug | Control |
Primary outcome
PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen)
Time frame: 2 hours post-lung transplantation
PaO2/FiO2 ratio
Time frame: 6 hours post-lung transplantation
PaO2/FiO2 ratio
Time frame: 12 hours post-lung transplantation
PaO2/FiO2 ratio
Time frame: 18 hours post-lung transplantation
PaO2/FiO2 ratio
Time frame: 24 hours post-lung transplantation
PaO2/FiO2 ratio
Time frame: 36 hours post-lung transplantation
PaO2/FiO2 ratio
Time frame: 48 hours post-lung transplantation
PaO2/FiO2 ratio
Time frame: 60 hours post-lung transplantation
PaO2/FiO2 ratio
Time frame: 72 hours post-lung transplantation
1 secondary outcome
primary graft failure grade
Time frame: 72 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2019.
- Individual participant dataSharing planned: No
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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.
François TRONC, Pr principal investigator
Hospices Civils de Lyon
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 Cyclosporine A in people with Lung Transplantation, run by Hospices Civils de Lyon at 1 site in France.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 14 Mar 2019. 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 France. 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. Some participants in this study may receive a placebo. 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 withdrawn before enrolling participants, so there are no results.
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?
PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen) (time frame: 2 hours post-lung transplantation). The study lists 9 primary outcomes in all. 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 14 Mar 2019.