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

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

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Transplant
• Intervention / Treatment: Drug: TacroBell SR cap.; Drug: Tacrolimus cap.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 184
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • The Catholic University of Korea, Seoul, St.Mary's Hospital.
    • Contact: Chul Woo Yang, Ph.D; Phone Number: 82-2-2258-6037; Email: yangch@catholic.ac.kr
    • Contact: Jae Ri Bae; Phone Number: 82-2-2194-0468; Email: jaeri@ckdpharm.com
    • Principal Investigator: Chul Woo Yang, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Once-Daily Tacrolimus; Experimental arm: TacroBell SR Cap.	Drug: TacroBell SR cap.; 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.; Other Names: Tacrolimus SR cap.
Active Comparator: Twice a Day Tacrolimus; Active Comparator arm: TacroBell Cap.	Drug: Tacrolimus cap.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): December 17, 2018
• Primary Completion (Anticipated): July 30, 2020
• Study Completion (Anticipated): November 30, 2020

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): January 13, 2020
• Last Update Submitted That Met QC Criteria: January 9, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: 211KT18017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No