Kidney TransplantPhase 4NCT04224350
Study to Evaluate the Efficacy and Safety of Tacrolimus in Kidney Transplant Recipients (BLOSSOM)
A Phase 4 study testing TacroBell SR cap. and Tacrolimus cap. in people with Kidney Transplant, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- TacroBell SR cap. and Tacrolimus cap.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Dec 2018to 30 Nov 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea, Seoul, St.Mary's Hospital.
Seoul
Chul Woo Yang, Ph.D, 82-2-2258-6037, yangch@catholic.ac.kr
Jae Ri Bae, 82-2-2194-0468, jaeri@ckdpharm.com
About this study
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
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.
Read the 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.
- Conditions
- Kidney Transplant
- Being tested
- TacroBell SR cap., Tacrolimus cap.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TacroBell SR cap.Drug
Also called Tacrolimus 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.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.
| Study group | Role | What they receive |
|---|---|---|
| Once-Daily Tacrolimus | Experimental | Experimental arm: TacroBell SR Cap. Receives: Drug: TacroBell SR cap. |
| Twice a Day Tacrolimus | Active comparator | Active Comparator arm: TacroBell Cap. Receives: Drug: Tacrolimus cap. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)
Measured: until 24 weeks
Secondary outcomes (6)
Incidence of biopsy-confirmed acute rejection(TCMR, AMR)
Measured: until 24 weeks
Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy
Measured: until 24 weeks
Survival rate of transplanted organ
Measured: until 24 weeks
Survival rate of Patients
Measured: until 24 weeks
Serum-Cr value
Measured: until 24 weeks
eGFR(eGFR using CKD-EPI method) value
Measured: until 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start17 Dec 2018
- Primary completion30 Jul 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224350
- Sponsor's protocol ID
- 211KT18017
- Status last verified
- Jan 2020
- First submitted
- 8 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04224350
- Acronym / sponsor ID
- 211KT18017
- Conditions
- Kidney Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 17 Dec 2018 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Once-Daily Tacrolimus | Experimental | Drug: TacroBell SR cap.Experimental arm: TacroBell SR Cap. |
| Twice a Day Tacrolimus | Active comparator | Drug: Tacrolimus cap.Active Comparator arm: TacroBell Cap. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TacroBell SR cap.Also: Tacrolimus 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. | Drug | Once-Daily Tacrolimus |
| 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. | Drug | Twice a Day Tacrolimus |
Primary outcome
Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)
Time frame: until 24 weeks
6 secondary outcomes
Incidence of biopsy-confirmed acute rejection(TCMR, AMR)
Time frame: until 24 weeks
Pathologic Results, Occurrence, Treatment Methods, and Results of Acute Rejection Confirmed by Biopsy
Time frame: until 24 weeks
Survival rate of transplanted organ
Time frame: until 24 weeks
Survival rate of Patients
Time frame: until 24 weeks
Serum-Cr value
Time frame: until 24 weeks
eGFR(eGFR using CKD-EPI method) value
Time frame: until 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TacroBell SR cap. and Tacrolimus cap. in people with Kidney Transplant, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chul Woo Yang, Ph.D (82-2-2258-6037, yangch@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure) (time frame: until 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.