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| ID | Type | Description | Link |
|---|---|---|---|
| CERL080AKR07T | Other Grant/Funding Number | NORVATIS |
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| Name | Class |
|---|---|
| Seoul National University Hospital | OTHER |
| Samsung Medical Center | OTHER |
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To clarify that tacrolimus-sparing regimen with minimal tacrolimus dose together with mycophenolate sodium dose increment will preserve renal allograft function without rising adverse effects
Primary endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| routine dose tacrolimus and less myfortic | Active Comparator |
| |
| reduced dose tacrolimus and conventional myfortic | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| routine dose tacrolimus and less myfortic | Drug | oral regular dose of tacrolimus + less dose of myfortic trough level of tacrolimus will be 5-10 ng/mL and oral myfortic dose will be 180-360 mg twice a day |
| Measure | Description | Time Frame |
|---|---|---|
| estimated GFR (MDRD equation)12 months after randomization | 12 months after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Urine protein excretion | 24hr urine collection or urine protein/creatinine ratio | 12 months after randomization |
| graft survival | 12 month graft survival |
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<Inclusion criteria>
<Exclusion criteria>
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| Name | Affiliation | Role |
|---|---|---|
| Su-Kil Park, MD,PhD | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | Asan Medical Center | 138-736 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29891834 | Derived | Park S, Kim YS, Lee J, Huh W, Yang CW, Kim YL, Kim YH, Kim JK, Oh CK, Park SK. Reduced Tacrolimus Trough Level Is Reflected by Estimated Glomerular Filtration Rate (eGFR) Changes in Stable Renal Transplantation Recipients: Results of the OPTIMUM Phase 3 Randomized Controlled Study. Ann Transplant. 2018 Jun 12;23:401-411. doi: 10.12659/AOT.909036. |
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| reduced dose tacrolimus and conventional myfortic | Drug | low dose of tacrolimus + maximum dose of myfortic target trough level of tacrolimus should be reduced to 2-5 ng/mL for 3 months after randomization and oral MPS dose increased to 540-720mg twice a day |
|
| 12 month after randomization |
| follow-up loss | frequency of follow-up loss | From randomization to 12 months after randomization |
| Allograft biopsy | number of performed allograft biopsy performed | From randomization to 12 months after randomization |
| Treated or biopsy proven acute rejection | From randomization to 12 months after randomization |
| estimated GFR change from randomization to end of the study | calculated by MDRD equation and Nankivell equation | 12 months after randomization |