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This is a prospective randomized controlled study to evaluate feasibility and safety of early steroid withdrawal after 6mg/kg vs 4.5mg/kg Thymoglobulin induction therapy in kidney transplantation. Patients are enrolled from June, 2015 for 24 months. They are randomized to either 6mg/kg or 4.5mg/kg Thymoglobulin induction group. Steroid withdrawal is done within one week after kidney transplantation for all the patients. Maintenance immunosuppressants are Tacrolimus and Mycophenolate mofetil (or Myfortic). Primary outcome is a composite of biopsy-proven acute rejection, delayed graft function, graft loss or death within one year post transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 6.0ATG | Active Comparator | Recipients who have 6.0 mg/kg Thymoglobulin as induction therapy |
|
| 4.5ATG | Active Comparator | Recipients who have 4.5 mg/kg Thymoglobulin as induction therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thymoglobulin | Drug | 6.0 mg/kg vs 4.5 mg/kg Thymoglobulin |
|
| Measure | Description | Time Frame |
|---|---|---|
| A composite outcome of biopsy-proven acute rejection, delayed graft function, graft loss, and death | 12 months after kidney transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic findings according to Banff 2013 criteria | 1 day at the time of biopsy | |
| Overall rate of acute rejection | 12 months after kidney transplantation | |
| The rate of steroid-free immunosuppressive regimen |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36857393 | Derived | Ko Y, Wee YM, Shin S, Kim MJ, Choi MY, Kim DH, Lim SJ, Jung JH, Kwon H, Kim YH, Han DJ. A prospective, randomized, non-blinded, non-inferiority pilot study to assess the effect of low-dose anti-thymocyte globulin with low-dose tacrolimus and early steroid withdrawal on clinical outcomes in non-sensitized living-donor kidney recipients. PLoS One. 2023 Mar 1;18(3):e0280924. doi: 10.1371/journal.pone.0280924. eCollection 2023. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C512542 | thymoglobulin |
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| 12 months after kidney transplantation |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |