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Completed

NCT Number: NCT04102943

Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus in Kidney Transplant Recipients.

The purpose of this study is to evaluate the pharmacokinetics and tolerability of Tacrolimus tablet(TacroBell) in kidney transplant recipients.

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Treatment and study plan

tacrolimus tablet

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 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.

Other names: tacrobell tablet

Tacrolimus Capsules

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 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.

Other names: prograf capsules

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Tmax (Time of peak concentration)

    Time frame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)

    Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules

  2. 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)

    Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules

  3. Cmax (Maximum concentration of drug in serum)

    Time frame: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)

    Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules

  4. 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)

    Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules

  5. Tmax (Time of peak concentration)

    Time frame: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)

    Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules

  6. 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)

    Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules

  7. 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)

    Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules

  8. 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)

    Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules

  9. 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)

    Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules

  10. 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)

    Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Official study title

Single Center, Randomized, Open-label, Phase IV Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus Tablet(TacroBell) in Kidney Transplant Recipients.

Acronym: PK-TACT

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 25, 2019
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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