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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| new strategy of immunosuppression monitoring | Experimental | evaluation of calcineurin activity (CN-a) in combination with CNI blood levels |
|
| strategy of reference | Active Comparator | CNI (inhibitor of Calcineurin) blood levels alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| levels of CNI in whole blood | Biological |
| ||
| Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs) |
| Measure | Description | Time Frame |
|---|---|---|
| number of episodes of acute rejection after LTx | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Martine Reynaud Gaubert, Professor | Contact | martine.reynaud@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Urielle Desalbres | Assistance Publique Hôpitaux de Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille | Marseille | Marseille | 13354 | France |
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| Biological |
|
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019703 | Calcineurin |
| ID | Term |
|---|---|
| D010749 | Phosphoprotein Phosphatases |
| D010744 | Phosphoric Monoester Hydrolases |
| D004950 | Esterases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D047908 | Intracellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
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