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

Chong Kun Dang

Status and phase: Unknown; Phase 4

Conditions: Kidney Transplant

Treatments: Drug: TacroBell SR cap.; Drug: Tacrolimus cap.

Study type: Interventional

Funder types: Industry

Identifiers

NCT04224350

211KT18017

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 184 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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184 participants in 2 patient groups

Once-Daily Tacrolimus

Experimental group

Description:

Experimental arm: TacroBell SR Cap.

Treatment:

Drug: TacroBell SR cap.

Twice a Day Tacrolimus

Active Comparator group

Description:

Active Comparator arm: TacroBell Cap.

Treatment:

Drug: Tacrolimus cap.