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

Kidney Transplant Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04224350
• Other study ID #: 211KT18017
• Status: Recruiting
• Phase: Phase 4
• Start date: December 17, 2018
• Est. completion date: November 30, 2020

Study information

• Verified date: January 2020
• Source: Chong Kun Dang Pharmaceutical
• Contact: Chul Woo Yang, Ph.D
• Phone: 82-2-2258-6037
• Email: yangch[@]catholic.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: November 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	The Catholic University of Korea, Seoul, St.Mary's Hospital.	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)		until 24 weeks
Secondary	Incidence of biopsy-confirmed acute rejection(TCMR, AMR)		until 24 weeks
Secondary	Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy		until 24 weeks
Secondary	Survival rate of transplanted organ		until 24 weeks
Secondary	Survival rate of Patients		until 24 weeks
Secondary	Serum-Cr value		until 24 weeks
Secondary	eGFR(eGFR using CKD-EPI method) value		until 24 weeks