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

Kidney Transplant Clinical Trial

— PK-TACT  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04102943
• Other study ID #: 211KT17009
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: November 30, 2017
• Est. completion date: January 10, 2021

Study information

• Verified date: January 2020
• Source: Chong Kun Dang Pharmaceutical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 128
• Est. completion date: January 10, 2021
• Est. primary completion date: August 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	AUC8 (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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	AUC8 (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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Dose normalized AUC8(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)