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The main purpose of this study is to identify cyclosporine C2 levels during 12 months treatment , while cyclosporine microemulsion dosages are adjusted based on C0 cyclosporine blood samples, and retrospectively correlate C2 levels to outcome (renal function and incidence of acute rejections)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cyclosporine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine | Drug | patients will receive maintenance triple immunosuppression according to local practice consisting of Sandimmun Neoral, MMF/ECMPA or azathioprin and steroids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The average number of treated acute cardiac and lung graft rejection per patient during the first 12 months post transplant | ||
| The measured Glomerular Filtration Rate (GFR) at 3 and 12 months post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treated acute rejections | ||
| Incidence of biopsy-proven acute cellular rejections | ||
| Patient and Graft survival rates |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may applied
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis | Basel | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19716045 | Derived | Iversen M, Nilsson F, Sipponen J, Eiskjaer H, Mared L, Bergan S, Nystrom U, Fagertun HE, Solbu D, Simonsen S. Cyclosporine C2 levels have impact on incidence of rejection in de novo lung but not heart transplant recipients: the NOCTURNE study. J Heart Lung Transplant. 2009 Sep;28(9):919-26. doi: 10.1016/j.healun.2009.05.022. |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |