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The investigators analyze the clinical outcome of steroid withdrawal protocol starting at 3 months after kidney transplantation using tacrolimus, Mycophenolate Mofetil (MMF), and basiliximab. This study is an open-label, prospective, controlled clinical trial in a single center. Those patients who fulfill the entry criteria could enter in this prospective controlled trial of steroid withdrawal three months after transplantation.
Those patients who fulfill the entry criteria enter in this prospective controlled trial of steroid withdrawal starting at three months after transplantation. The entry criteria include 1) no episode of clinically treated nor biopsy confirmed acute rejection up to entry; 2) serum creatinine level equal to or less than 2 mg/mL on three separate measurements; 3) no proteinuria (urine protein less than 1000 mg/24 hours; 4) tacrolimus trough level > 5 ng/ml without signs of nephrotoxicity; 5) agreement to follow the study protocol.
For the patients who enter into the protocol, prednisolone would be slowly withdrawn by 2.5 mg in every two weeks until 8 weeks after entering the protocol (5 months post-transplantation). The patients visit every week, and they are closely monitored with symptoms and signs, blood cell count, chemistry, and urinalysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| steroid withdrawal | No Intervention | The clinical outcome after kidney transplantation, under the immunosuppression of steroid withdrawal starting at 3 months post-transplantation using tacrolimus, mycophenolate mofetil, and basilixumab should be analyzed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | Those patients who fulfill the entry criteria enter in this prospective controlled trial of steroid withdrawal starting at three months after transplantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| the incidence of biopsy-confirmed acute rejection. | The primary efficacy variable was the incidence of biopsy-confirmed acute rejection. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| death, graft loss | The secondary efficacy variables included the cumulative incidence of a composite endpoint of death, and graft loss; | 12 months |
| adverse events and serious adverse events | The proportion of successfully steroid-withdrawn and steroid-free population at 6 months and at 12 months post-transplantation as well as the safety variables including the incidence of adverse events and serious adverse events, [blood pressure, lipid levels (total cholesterol), BUN (blood urea nitrogen) and blood glucose levels] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| chang-kwon Oh, M.D | Contact | 82-10-9165-7281 | ohck@ajou.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Chang kwon oh, M.D.,Ph. D. | Department of surgery, Ajou University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ajou University Hospital | Recruiting | Suwon | 443-749 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22468094 | Derived | Oh CK, Kim SJ, Kim JH, Lee JH. Prospective controlled protocol for three months steroid withdrawal with tacrolimus, basiliximab, and mycophenolate mofetil in renal transplant recipients. J Korean Med Sci. 2012 Apr;27(4):337-42. doi: 10.3346/jkms.2012.27.4.337. Epub 2012 Mar 21. |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| 6 months , 12 months |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |