Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Multi Center, Non-comparative, Phase IV Study to Evaluate the Efficacy and Safety of Once-Daily Prolonged Release Tacrolimus Capsule(TacroBell SR Cap.) in Kidney Transplant Recipients

Conditions
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Kidney Transplant

Intervention / Treatment
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* Drug: TacroBell SR cap.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Once-Daily Tacrolimus<br>One arm: TacroBell SR Cap. | Drug: TacroBell SR cap.<br>* 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.<br>* Other names: Tacrolimus SR cap.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure) | The frequency and percentage of composite efficacy failure(biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure) | until 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy-confirmed acute rejection(TCMR, AMR) | The frequency and Incidence | until 24 weeks | 
| Pathological results of acute rejection | By Banff classification categories | until 24 weeks | 
| Survival rate of transplated organ | Kaplan-Meier | at 24 weeks | 
| Survival rate of Patients | Kaplan-Meier | at 24 weeks | 
| Serum-Cr, eGFR | eGFR using CKD-epi method | at 24 weeks | 
| Evaluate safety of TacroBell SR. cap. from number of participants with adverse events | safety data | until 24 weeks |