NCT04224350

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
184

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 17, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 13, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

1.6 years

First QC Date

January 8, 2020

Last Update Submit

January 9, 2020

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (1)

  • Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)

    until 24 weeks

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Once-Daily Tacrolimus

EXPERIMENTAL

Experimental arm: TacroBell SR Cap.

Drug: TacroBell SR cap.

Twice a Day Tacrolimus

ACTIVE COMPARATOR

Active Comparator arm: TacroBell Cap.

Drug: Tacrolimus cap.

Interventions

TacroBell SR cap.DRUG

* 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.

Also known as: Tacrolimus SR cap.
Once-Daily Tacrolimus
Tacrolimus cap.DRUG

* 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.

Twice a Day Tacrolimus

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Korea, Seoul, St.Mary's Hospital.

Seoul, South Korea

RECRUITING

Central Study Contacts

Chul Woo Yang, Ph.D

CONTACT

82-2-2258-6037yangch@catholic.ac.kr

Jae Ri Bae

CONTACT

82-2-2194-0468jaeri@ckdpharm.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2020

First Posted

January 13, 2020

Study Start

December 17, 2018

Primary Completion

July 30, 2020

Study Completion

November 30, 2020

Last Updated

January 13, 2020

Record last verified: 2020-01

Locations

KR(1)