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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04224350
Other study ID # 211KT18017
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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