Lung DiseasesCalciMo-TPNCT02897895
Study to Evaluate the Value of the Follow-up of CALCIneurin Activity to MOdulate Calcineurin Inhibitors-induced Immunosuppression in Lung Transplantation
A study testing levels of CNI in whole blood and Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs) in people with Lung Diseases, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The study is an interventional, multicentre, prospective, randomized, controlled, single-blind, comparative trial of two processes for adjusting the inhibitor of calcineurin (CNI) dosage in lung transplant recipients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- What is being tested?
- levels of CNI in whole blood and Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2016to Dec 2022
- Phase
- Interventional
- 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
- Patient placed on the national waiting list for lung transplantation
- First de novo lung transplantation (single or double LTx)
- Prevention of allograft rejection by a usual immunosuppressive regimen including CNI (cyclosporine or tacrolimus)
Who cannot join
- Previous lung transplantation or other solid organ transplantation
- Combined lung transplantation with either liver or renal transplantation
Trial locations and contacts
1 site in 1 country.
Martine Reynaud Gaubert, Professor contact
France1 site
Assistance Publique Hopitaux de Marseille
Marseille, Marseille, 13354
reynaud gaubert martine, martine.reynaud@ap-hm.fr
reynaud gaubert martine
About this study
The study is an interventional, multicentre, prospective, randomized, controlled, single-blind, comparative trial of two processes for adjusting the inhibitor of calcineurin (CNI) dosage in lung transplant recipients. Recipients will be stratified by transplant center and according to the underlying lung disease (affected with cystic fibrosis or not) and will be randomized to either evaluation of calcineurin activity (CN-a) in combination with CNI blood levels versus CNI blood levels alone in a 1:1 ratio. The objective is to compare the proportion of acute rejection that has required a specific curative treatment at 6 months after transplantation between patients in the two groups.
- Conditions
- Lung Diseases
- Being tested
- levels of CNI in whole blood, Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)
- Keywords
- Lung transplantation in end-stage lung diseases
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levels of CNI in whole bloodBiological
Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)Biological
| Study group | Role | What they receive |
|---|---|---|
| new strategy of immunosuppression monitoring | Experimental | evaluation of calcineurin activity (CN-a) in combination with CNI blood levels Receives: Biological: levels of CNI in whole blood; Biological: Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs) |
| strategy of reference | Active comparator | CNI (inhibitor of Calcineurin) blood levels alone Receives: Biological: levels of CNI in whole blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of episodes of acute rejection after LTx
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 posted13 Sep 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle Desalbres, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897895
- Sponsor's protocol ID
- 2014-16
- Acronym
- CalciMo-TP
- Status last verified
- Sep 2016
- First submitted
- 8 Sep 2016
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Evaluate the Value of the Follow-up of CALCIneurin Activity to MOdulate Calcineurin Inhibitors-induced Immunosuppression in Lung Transplantation
- ClinicalTrials.gov ID
- NCT02897895
- Acronym / sponsor ID
- CalciMo-TP / 2014-16
- Conditions
- Lung Diseases
- Keywords
- Lung transplantation in end-stage lung diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 134 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Sep 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 study is an interventional, multicentre, prospective, randomized, controlled, single-blind, comparative trial of two processes for adjusting the inhibitor of calcineurin (CNI) dosage in lung transplant recipients. Recipients will be stratified by transplant center and according to the underlying lung disease (affected with cystic fibrosis or not) and will be randomized to either evaluation of calcineurin activity (CN-a) in combination with CNI blood levels versus CNI blood levels alone in a 1:1 ratio. The objective is to compare the proportion of acute rejection that has required a specific curative treatment at 6 months after transplantation between patients in the two groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| new strategy of immunosuppression monitoring | Experimental | Biological: levels of CNI in whole blood, Biological: Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)evaluation of calcineurin activity (CN-a) in combination with CNI blood levels |
| strategy of reference | Active comparator | Biological: levels of CNI in whole bloodCNI (inhibitor of Calcineurin) blood levels alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient placed on the national waiting list for lung transplantation
- First de novo lung transplantation (single or double LTx)
- Prevention of allograft rejection by a usual immunosuppressive regimen including CNI (cyclosporine or tacrolimus)
Key exclusion criteria (2 listed)
- Previous lung transplantation or other solid organ transplantation
- Combined lung transplantation with either liver or renal transplantation
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 |
|---|---|---|
| levels of CNI in whole blood | Biological | new strategy of immunosuppression monitoring, strategy of reference |
| Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs) | Biological | new strategy of immunosuppression monitoring |
Primary outcome
number of episodes of acute rejection after LTx
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
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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.
Martine Reynaud Gaubert, Professor contact
Urielle Desalbres study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing levels of CNI in whole blood and Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs) in people with Lung Diseases, run by Assistance Publique Hopitaux De Marseille 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 3 inclusion and 2 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 13 Sep 2016. 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. 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 Martine Reynaud Gaubert, Professor (martine.reynaud@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of episodes of acute rejection after LTx (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 13 Sep 2016.