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The purpose of this study is to assess if a combination of everolimus, steroids, and mycophenolate mofetil is associated with a better renal function than sirolimus.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function at M6 (glomerular filtration and tubular function). |
| Measure | Description | Time Frame |
|---|---|---|
| Renal function (other tubular function parameters) | ||
| Incidence of biopsy-proven acute rejections and CMV infections | ||
| Laboratory parameters: hemoglobin, WBC, T-cell sub-populations, platelets, transaminases, total cholesterol, HDL and LDL cholesterol, apolipoproteins A1 and B, triglycerides, fasting glucose, HbA1c, LH, FSH, testosterone and TSH |
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Inclusion Criteria:
Exclusion Criteria
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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 |
|---|---|---|---|
| 18793527 | Result | Kamar N, Jaafar A, Esposito L, Ribes D, Durand D, Di-Giambattista F, Tack I, Rostaing L. Conversion from sirolimus to everolimus in maintenance renal transplant recipients within a calcineurin inhibitor-free regimen: results of a 6-month pilot study. Clin Nephrol. 2008 Aug;70(2):118-25. doi: 10.5414/cnp70118. |
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| Mucous and cutaneous disorders |
| Adverse events and serious adverse events, premature study treatment discontinuations. |
| Monitoring of everolimus trough levels. |
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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