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Single center, open-label randomized-control trial Population: de novo 48 kidney transplant recipients (age 18-75 years) from ECD/AKI donors Compare: everolimus with low dose CNI and prednisolone versus standard immunosuppressive regimen Objective: To evaluate efficacy of everolimus with low dose CNI in de novo kidney transplant recipients of ECD/AKI donors Primary endpoint: Mean eGFR (CKD-EPI) at 12 months post-transplantation
Secondary Endpoints:
Definition of ECD
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: investigation arm | Experimental | De novo kidney transplantation form ECD/AKI donor with Everolimus + low dose cyclosporinA + prednisolone as immunosuppressive regimen |
|
| B: control arm | Other | De novo kidney transplantation form ECD/AKI donor with standard immunosuppressive regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus + low dose cyclosporin A + prednisolone | Drug |
| ||
| Standard immunosupressive regimen |
| Measure | Description | Time Frame |
|---|---|---|
| eGFR (CKD-EPI) | 12 months post kidney transplantation |
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Inclusion Criteria:
Exclusion Criteria:
Multi-organ recipients
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| Name | Affiliation | Role |
|---|---|---|
| Surasak Kantachuvesiri, M.D., PH.D | Ramathibodi Hospital, Mahidol University | Principal Investigator |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| D016572 | Cyclosporine |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D003524 |
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| Drug |
|
| Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |