Kidney TransplantPhase 4PK-TACTNCT04102943
Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus in Kidney Transplant Recipients.
A Phase 4 study testing tacrolimus tablet and tacrolimus capsules 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 pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) in kidney transplant recipients. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Transplant
- What is being tested?
- tacrolimus tablet and tacrolimus capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Nov 2017to 29 Sep 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 19 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
- 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
- Inadequate for registration under the judgment of the investigator due to severe gastrointestinal disorders
- Severe systemic infection requiring treatment
- Prior to the kidney transplantation
Show all 12Show fewer
- Treatment with active liver disease or Liver function test(T-bilirubin, Aspartate transaminase(AST), Alanine transaminase(ALT))is over 3 times than upper normal limit
- White Blood Cell(WBC) <2.5 x10^3/μL, or platelet <75 x10^3/μL
- 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.
About this study
Official title: Single Center, Randomized, Open-label, Phase IV Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus Tablet(TacroBell) in Kidney Transplant Recipients.
The purpose of this study is to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) in kidney transplant recipients.
Read the detailed description
This study is a Single center, randomized, open-label, Phase IV study to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) administration for 24 Weeks in patients after renal transplantation.
- Conditions
- Kidney Transplant
- Being tested
- tacrolimus tablet, tacrolimus capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tacrolimus tabletDrug
Also called tacrobell tablet
- 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 acheive 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.
tacrolimus capsulesDrug
Also called prograf capsules
- 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 acheive 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 |
|---|---|---|
| Tacrolimus1 | Experimental | Tacrolimus tablet 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. Receives: Drug: tacrolimus tablet |
| Tacrolimus2 | Active comparator | 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. Receives: Drug: tacrolimus capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Maximum concentration of drug in serum)
Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Measured: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
AUCt (Area under the plasma concentration-time curve from time zero to time t)
Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Measured: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
Secondary outcomes (10)
Tmax (Time of peak concentration)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Measured: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
AUC∞ (Area under the plasma concentration-time curve from time zero to infinity)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Measured: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
Cmax (Maximum concentration of drug in serum)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Measured: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
AUCt (Area under the plasma concentration-time curve from time zero to time t)
Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Measured: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Tmax (Time of peak concentration)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Measured: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
AUC∞ (Area under the plasma concentration-time curve from time zero to infinity)
Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Measured: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Dose normalized Cmax(Maximum concentration of drug in serum)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Measured: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Dose normalized AUCt(Area under the plasma concentration-time curve from time zero to time t)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Measured: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Dose normalized Tmax(Time of peak concentration)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Measured: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Dose normalized AUC∞(Area under the plasma concentration-time curve from time zero to infinity)
Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
Measured: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start30 Nov 2017
- Primary completion29 Sep 2020
- Study completion29 Sep 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
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
- NCT04102943
- Sponsor's protocol ID
- 211KT17009
- Acronym
- PK-TACT
- Status last verified
- Mar 2022
- First submitted
- 28 Aug 2019
- Last updated
- 15 Apr 2026
- 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 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Randomized, Open-label, Phase IV Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus Tablet(TacroBell) in Kidney Transplant Recipients.
- ClinicalTrials.gov ID
- NCT04102943
- Acronym / sponsor ID
- PK-TACT / 211KT17009
- Conditions
- Kidney Transplant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2017 (actual)
- Primary completion
- 29 Sep 2020 (actual)
- Study completion
- 29 Sep 2020 (actual)
- First posted
- 25 Sep 2019 (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 pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) in kidney transplant recipients.
Detailed description
This study is a Single center, randomized, open-label, Phase IV study to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) administration for 24 Weeks in patients after renal transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tacrolimus1 | Experimental | Drug: tacrolimus tabletTacrolimus tablet 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. |
| Tacrolimus2 | Active comparator | Drug: tacrolimus capsulesTacrolimus 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. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 19 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 (12 listed)
- Previously received organs other than kidneys or who are planed to be transplanted simultaneously
- 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
- Inadequate for registration under the judgment of the investigator due to severe gastrointestinal disorders
- Severe systemic infection requiring treatment
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 |
|---|---|---|
| tacrolimus tabletAlso: tacrobell tablet* 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 acheive 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 | Tacrolimus1 |
| tacrolimus capsulesAlso: prograf capsules* 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 acheive 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 | Tacrolimus2 |
Primary outcome
Cmax (Maximum concentration of drug in serum)
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
AUCt (Area under the plasma concentration-time curve from time zero to time t)
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules
10 secondary outcomes
Tmax (Time of peak concentration)
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
AUC∞ (Area under the plasma concentration-time curve from time zero to infinity)
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
Cmax (Maximum concentration of drug in serum)
Time frame: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
AUCt (Area under the plasma concentration-time curve from time zero to time t)
Time frame: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Tmax (Time of peak concentration)
Time frame: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
AUC∞ (Area under the plasma concentration-time curve from time zero to infinity)
Time frame: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Dose normalized Cmax(Maximum concentration of drug in serum)
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Dose normalized AUCt(Area under the plasma concentration-time curve from time zero to time t)
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Dose normalized Tmax(Time of peak concentration)
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
Dose normalized AUC∞(Area under the plasma concentration-time curve from time zero to infinity)
Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours), At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
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 15 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 tacrolimus tablet and tacrolimus capsules 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 12 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 15 Apr 2026. 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?
Cmax (Maximum concentration of drug in serum) (time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)). The study lists 2 primary outcomes in all. 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 15 Apr 2026.