Kidney Transplant
Conditions
Brief summary
The purpose of this study is to evaluate the efficacy and safety and of Once-Daily Tacrolimus (TacroBell SR Cap.) in patients who received renal transplantation.
Detailed description
This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of combined Once-Daily Tacrolimus (TacroBell SR Cap.) administration for 24 weeks in patients with immunosuppressive therapies after renal transplantation.
Interventions
* Orally, once-daily in the morning * After first dose 0.2mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3\ 12ng/ml for 0 to 3months and then at 3\ 8ng/ml for 3 to 6months of study treatment.
Sponsors
Chong Kun Dang Pharmaceutical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Over 20 years old(male or female) * Patients who are planning to receive a kidney from a deceased or a living non-related/related donor * Agreement with written informed consent
Exclusion criteria
* Previously received organs other than kidneys or who are planed to be transplanted simultaneously * Receive a kidney from a donor whose ABO blood type is not compatible with that of the recipient * Receive a kidney from a related donor who showed HLA-0 mismatch (identical) * Undergo desensitization therapy with high sensitization * Diagnosed with cancer in the last five years \[Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer can be enrolled.\] * Patients or donors who have positive HIV test result * Inadequate for registration under the judgment of the investigator due to severe gastrointestinal disorders * Severe systemic infection requiring treatment * Prior to the kidney transplantation * Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit * WBC\< 2,500/mm\^3, or platelet \< 75,000/mm\^3, or ANC \< 1,300/mm\^3 * Pregnant women or nursing mothers * Fertile women who not practice contraception with appropriate methods * Participated in other trial within 4 weeks * In investigator's judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure) | until 24 weeks | The frequency and percentage of composite efficacy failure(biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological results of acute rejection | until 24 weeks | By Banff classification categories |
| Survival rate of transplated organ | at 24 weeks | Kaplan-Meier |
| Incidence of biopsy-confirmed acute rejection(TCMR, AMR) | until 24 weeks | The frequency and Incidence |
| Serum-Cr, eGFR | at 24 weeks | eGFR using CKD-epi method |
| Evaluate safety of TacroBell SR. cap. from number of participants with adverse events | until 24 weeks | safety data |
| Survival rate of Patients | at 24 weeks | Kaplan-Meier |
Countries
South Korea
Outcome results
None listed