Clinical trial NCT04224350: Study to Evaluate the Efficacy and Safety of Tacrolimus in Kidney Transplant Recipients (BLOSSOM)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Transplant
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-01-13
Enrollment: 184
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)
timeFrame: until 24 weeks
Secondary outcomes:
measure: Incidence of biopsy-confirmed acute rejection(TCMR, AMR)
timeFrame: until 24 weeks
measure: Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy
timeFrame: until 24 weeks
measure: Survival rate of transplanted organ
timeFrame: until 24 weeks
measure: Survival rate of Patients
timeFrame: until 24 weeks
measure: Serum-Cr value
timeFrame: until 24 weeks
measure: eGFR(eGFR using CKD-EPI method) value
timeFrame: until 24 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul, St.Mary's Hospital.
Study officials:
References: