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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
| Sanofi | INDUSTRY |
The disparity between supply and demand for organs has stimulated the development of strategies to increase the availability of kidney grafts. Such strategy involves the use of kidneys with expanded donor criteria (EDC). This is a study initiated by the investigator, open, prospective, randomized, single center designed to compare the safety and efficacy of two immunosuppressive regimens based on thymoglobulin, tacrolimus and everolimus versus thymoglobulin, tacrolimus and mycophenolate sodium in renal transplant recipients with donor criteria expanded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mycophenolate sodium | Active Comparator | Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium, and late introduction of tacrolimus |
|
| Everolimus | Experimental | Induction therapy with Thymoglobulin, prednisone, everolimus, and late introduction of tacrolimus. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimus | Drug |
| ||
| Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CMV disease | Incidence of CMV disease or infection during the first year of transplantation. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of treatment failure | To compare the two immunosuppressive regimens for the incidence of treatment failure defined as the composite endpoint of BPAR (biopsy-proven acute rejection), graft loss, death and loss to follow-up. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital do Rim e Hipertensao | São Paulo | 04038-002 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40197799 | Derived | Oliveras L, Lopez-Vargas P, Melilli E, Codina S, Royuela A, Coloma Lopez A, Fava A, Manonelles A, Couceiro C, Lloberas N, Cruzado JM, Montero N. Delayed initiation or reduced initial dose of calcineurin-inhibitors for kidney transplant recipients at high risk of delayed graft function. Cochrane Database Syst Rev. 2025 Apr 8;4(4):CD014855. doi: 10.1002/14651858.CD014855.pub2. | |
| 31278785 |
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| Drug |
|
| Derived |
| Ferreira AN, Felipe CR, Cristelli M, Viana L, Mansur J, de Paula M, Wagner D, de Marco R, Gerbase-DeLima M, Proenca H, Aguiar W, Medina-Pestana J, Tedesco-Silva Junior H. Prospective randomized study comparing everolimus and mycophenolate sodium in de novo kidney transplant recipients from expanded criteria deceased donor. Transpl Int. 2019 Nov;32(11):1127-1143. doi: 10.1111/tri.13478. Epub 2019 Aug 27. |
| ID | Term |
|---|---|
| D020360 | Neoadjuvant Therapy |
| C512542 | thymoglobulin |
| D011241 | Prednisone |
| D000068338 | Everolimus |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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