Kidney TransplantPhase 4OPIRUSNCT03749356
Study to Evaluate the Efficacy and Safety of Once-Daily Tacrolimus in Kidney Transplant Recipients
A Phase 4 study testing TacroBell SR 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 and of Once-Daily Tacrolimus (TacroBell SR Cap.) in patients who received renal transplantation. 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.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Sep 2018to 4 Dec 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 who are planning to receive a kidney from a deceased or a living non-related/related donor
- Agreement with written informed consent
Who cannot join
- Previously received organs other than kidneys or who are planed to be transplanted simultaneously
- Receive a kidney from a donor whose ABO blood type is not compatible with that of the recipient
- Receive a kidney from a related donor who showed HLA-0 mismatch (identical)
- Undergo desensitization therapy with high sensitization
- Diagnosed with cancer in the last five years [Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer can be enrolled.]
- Patients or donors who have positive HIV test result
Show all 15Show fewer
- Inadequate for registration under the judgment of the investigator due to severe gastrointestinal disorders
- Severe systemic infection requiring treatment
- Prior to the kidney transplantation
- Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit
- WBC< 2,500/mm^3, or platelet < 75,000/mm^3, or ANC < 1,300/mm^3
- Pregnant women or nursing mothers
- Fertile women who not practice contraception with appropriate methods
- Participated in other trial within 4 weeks
- In investigator's judgment
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance Hospital, Yonsei University Health System
Seoul
About this study
Official title: Multi Center, Non-comparative, Phase IV Study to Evaluate the Efficacy and Safety of Once-Daily Prolonged Release Tacrolimus Capsule(TacroBell SR Cap.) in Kidney Transplant Recipients
The purpose of this study is to evaluate the efficacy and safety and of Once-Daily Tacrolimus (TacroBell SR Cap.) in patients who received renal transplantation.
Read the detailed description
This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of combined Once-Daily Tacrolimus (TacroBell SR Cap.) administration for 24 weeks in patients with immunosuppressive therapies after renal transplantation.
- Conditions
- Kidney Transplant
- Being tested
- TacroBell SR 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 acheive 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.
| Study group | Role | What they receive |
|---|---|---|
| Once-Daily Tacrolimus | Experimental | One arm: TacroBell SR Cap. Receives: Drug: TacroBell SR 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)
The frequency and percentage 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)
The frequency and Incidence
Measured: until 24 weeks
Pathological results of acute rejection
By Banff classification categories
Measured: until 24 weeks
Survival rate of transplated organ
Kaplan-Meier
Measured: at 24 weeks
Survival rate of Patients
Kaplan-Meier
Measured: at 24 weeks
Serum-Cr, eGFR
eGFR using CKD-epi method
Measured: at 24 weeks
Evaluate safety of TacroBell SR. cap. from number of participants with adverse events
safety data
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 posted21 Nov 2018
- Study start5 Sep 2018
- Primary completion30 Jul 2020
- Study completion4 Dec 2020
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Seun Kim, Ph.D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749356
- Sponsor's protocol ID
- 211KT18008
- Acronym
- OPIRUS
- Status last verified
- Jan 2021
- First submitted
- 14 Nov 2018
- Last updated
- 5 Jan 2021
- 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 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi Center, Non-comparative, Phase IV Study to Evaluate the Efficacy and Safety of Once-Daily Prolonged Release Tacrolimus Capsule(TacroBell SR Cap.) in Kidney Transplant Recipients
- ClinicalTrials.gov ID
- NCT03749356
- Acronym / sponsor ID
- OPIRUS / 211KT18008
- Conditions
- Kidney Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 4 Dec 2020 (actual)
- First posted
- 21 Nov 2018 (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 and of Once-Daily Tacrolimus (TacroBell SR Cap.) in patients who received renal transplantation.
Detailed description
This study is a multi-center, non-comparative, and phase IV clinical trial that evaluates the efficacy and safety of combined Once-Daily Tacrolimus (TacroBell SR Cap.) administration for 24 weeks in patients with immunosuppressive therapies after renal transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Once-Daily Tacrolimus | Experimental | Drug: TacroBell SR cap.One arm: TacroBell SR Cap. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 20 years old(male or female)
- Patients who are planning to receive a kidney from a deceased or a living non-related/related donor
- Agreement with written informed consent
Key exclusion criteria (15 listed)
- Previously received organs other than kidneys or who are planed to be transplanted simultaneously
- Receive a kidney from a donor whose ABO blood type is not compatible with that of the recipient
- Receive a kidney from a related donor who showed HLA-0 mismatch (identical)
- Undergo desensitization therapy with high sensitization
- Diagnosed with cancer in the last five years [Patients, however, who have recovered from skin cancer (squamous cell/basal cell carcinoma) or thyroid cancer can be enrolled.]
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 acheive 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 |
Primary outcome
Incidence of composite efficacy failure (biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)
Time frame: until 24 weeks
The frequency and percentage of composite efficacy failure(biopsy-confirmed acute rejection; TCMR, graft loss, death, or follow-up failure)
6 secondary outcomes
Incidence of biopsy-confirmed acute rejection(TCMR, AMR)
Time frame: until 24 weeks
Pathological results of acute rejection
Time frame: until 24 weeks
Survival rate of transplated organ
Time frame: at 24 weeks
Survival rate of Patients
Time frame: at 24 weeks
Serum-Cr, eGFR
Time frame: at 24 weeks
Evaluate safety of TacroBell SR. cap. from number of participants with adverse events
Time frame: until 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Related trials for Kidney Transplant
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Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
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Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
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Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
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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.
Yu Seun Kim, Ph.D principal investigator
Severance Hospital
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. 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 3 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: finished, as of the sponsor's last update on 5 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 5 Jan 2021.