Study to Evaluate the Efficacy and Safety of Tacrolimus in Kidney Transplant Recipients (BLOSSOM)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and Safety after conversion to TacroBell SR cap. or TacroBell cap. in patients who in renal transplant patients undergoing maintenance therapy with Reference Tacrolimus.

Detailed Description
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This study is a multi-center, Randomized, Open-label and phase IV clinical trial that evaluates the efficacy and safety after conversion to TacroBell SR cap. or TacroBell cap. administration for 24 weeks in renal transplant patients undergoing maintenance therapy with Reference Tacrolimus.

Official Title
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Multi Center Randomized Open-label Phase IV Study to Compare the Efficacy and Safety After Conversion to TacroBell SR Capsule or TacroBell Capsule in Renal Transplant Patients Undergoing Maintenance Therapy With Reference Tacrolimus

Conditions
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Kidney Transplant

Intervention / Treatment
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* Drug: TacroBell SR cap.
* Drug: Tacrolimus cap.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 20 years old(male or female) Patients with eGFR (By CKD-EPI) ≥30mL/min/1.73m^2 and spot urine P/C ratio≤0.5 at screening test Patients who are taking Tacrolimus twice a day for maintenance therapy and have Trough level of 3 10ng/ml Agreement with written informed consent Exclusion Criteria: Patients who have transplanted organs other than kidney Patients with acute rejection who have been clinically treated within the last month Patients who have changed their administration of adjuvant immunosuppressants and corticosteroids within the last month (dose change, discontinuation, etc.) Patients who have been diagnosed with cancer within the last 5 years (except skin cancer or thyroid cancer determined by the investigator that treatment has been completed) Patients deemed inappropriate for screening due to severe digestive disorders at screening Patients with severe systemic infections requiring treatment (transplantation may be possible after the infection is completely lost or controlled) Patients with genetic problems of galactose-intolerance, Lapp lactose deficiency or glucose-galactose malabsorption If the following cases occur during screening Treatment of active liver disease or increased one or more of the liver function tests (T-bilirubin, AST, ALT) levels more than three times the upper limit of normal range Patients with WBC <2,500/mm^3, PLT <75,000/mm^3, ANC <1,300/μL Patients who have experienced hypersensitivity reactions or serious abnormalities with medicines used in this clinical trial or with similar chemical structures (Tacrolimus, etc.) Pregnant or lactating women Patients of childbearing potential who do not agree to the proper use of contraception during the trial Patients who received other investigational drugs within 4 weeks prior to consent of the document Patients unable to participate in the clinical trial due to the judgment of other investigators

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Once-Daily Tacrolimus<br>Experimental 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 achieve 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.;|
| Active Comparator: Twice a Day Tacrolimus<br>Active Comparator arm: TacroBell Cap. | Drug: Tacrolimus cap.<br>* Orally, twice a day in the morning and night After first dose 0.1mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 7 12ng/ml for 0 to 3months and then at 5 8ng/ml for 3 to 6months of study treatment.<br>|

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) |  | until 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy-confirmed acute rejection(TCMR, AMR) |  | until 24 weeks | 
| Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy |  | until 24 weeks | 
| Survival rate of transplanted organ |  | until 24 weeks | 
| Survival rate of Patients |  | until 24 weeks | 
| Serum-Cr value |  | until 24 weeks | 
| eGFR(eGFR using CKD-EPI method) value |  | until 24 weeks |