Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus in Kidney Transplant Recipients. (PK-TACT)

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Transplant
• Intervention / Treatment: Drug: tacrolimus tablet; Drug: tacrolimus capsules

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 Type: Interventional
• Enrollment (Anticipated): 128
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tacrolimus1; 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.	Drug: 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 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
Active Comparator: Tacrolimus2; 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: tacrolimus 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.; Other Names: prograf capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax (Maximum concentration of drug in serum)	Measurement of TDM of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules	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	At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax (Time of peak concentration)	Measurement of therapeutic drug concentration monitoring(TDM) of tacrolimus after administration of tacrolimus tablets or tacrolimus capsules	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	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	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	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	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	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	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	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	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	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)

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2017
• Primary Completion (Anticipated): August 28, 2020
• Study Completion (Anticipated): January 10, 2021

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: September 24, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): January 9, 2020
• Last Update Submitted That Met QC Criteria: January 6, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: 211KT17009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No