Kidney Transplantation
Conditions
Keywords
immunosuppression control in kidney transplantation
Brief summary
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: 1. estimated GFR (MDRD equation) 12 months after randomization 2. estimated GFR change from randomization to end of the study (calculated by MDRD equation and Nankivell equation)
Interventions
DRUGroutine dose tacrolimus and less myfortic
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
DRUGreduced dose tacrolimus and conventional myfortic
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
Sponsors
Seoul National University Hospital
Samsung Medical Center
Asan Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\<Inclusion criteria\> 1. The patients between the ages of 20 and 75 years who received kidney transplantation one to five years prior to the study. 2. Taking tacrolimus and corticosteroid, with or without additional purine synthesis inhibitor within the recent 3 months 3. Patients with serum creatinine (sCr) level ≤ 2.0 mg/dL and variation of sCr \< 30% for recent 3 months 4. Patients with urine proteinuria/creatinine ratio (PCR) ≤ 1 g/g, or 24 hour urine protein ≤ 1g/day for recent 3 months 5. Patients who provided informed consent. \<
Exclusion criteria
\> 1. Patients who received combined non-renal transplantation, multiple kidney transplantation or re-transplantation 2. Patients whose graft from non-heart beating cadaveric donor 3. graft from HLA-identical living related donor 4. ABO blood group incompatible donor or HLA desensitized recipients 5. Patients with hypersensitivity history to mycophenolate sodium, mycophenolate acid, or mycophenolate mofetil, or to any other excipients 6. Patients with hypoxanthin e-guanine phosphoribosyl-transferase such as Lesch-Nyhan syndrome and Kelley-Seegmiller syndrome 7. Patients with history of disease which could affect absorption of study medication (e.g. diabetic gastropathy, previous gastrectomy) 8. Patients with positive serologic test results, in recipient or donor, for human immunodeficiency virus, hepatitis B or C virus 9. Patients with liver function test abnormality (alanine aminotransferase, aspartate aminotransferase, or total bilirubin \> 3 times from upper normal limit), neutropenia (absolute neutrophil count \< 1,500/uL or white blood cell count \< 2,500/uL), or thrombocytopenia (platelet \< 75,000) 10. Patients with history of cancer within 5 years, except for successfully treated localized non-melanocytic skin cancer 11. Patients who were either pregnant, lactating, planning to become pregnant in the next 12 months 12. Patients who taken medicine from other trial within 30 days.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| estimated GFR (MDRD equation)12 months after randomization | 12 months after randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Allograft biopsy | From randomization to 12 months after randomization | number of performed allograft biopsy performed |
| Treated or biopsy proven acute rejection | From randomization to 12 months after randomization | — |
| follow-up loss | From randomization to 12 months after randomization | frequency of follow-up loss |
| Urine protein excretion | 12 months after randomization | 24hr urine collection or urine protein/creatinine ratio |
| graft survival | 12 month after randomization | 12 month graft survival |
| estimated GFR change from randomization to end of the study | 12 months after randomization | calculated by MDRD equation and Nankivell equation |
Countries
South Korea
Outcome results
None listed