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

Phase 4

• Conditions: Kidney Transplant
• Interventions: Drug: tacrolimus capsules; Drug: tacrolimus tablet

• Registration Number: NCT04102943
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

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 Timeline

• Study Start: 2017-11-30
• Study First Submitted: 2019-08-28
• Study First Submitted QC: 2019-09-24
• Study First Posted: 2019-09-25
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-06
• Last Update Posted: 2020-01-09
• Primary Completion: 2020-08-28
• Study Completion: 2021-01-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 128

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tacrolimus2	tacrolimus capsules	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.
Tacrolimus1	tacrolimus tablet	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.

Primary Outcome Measures

Name	Time	Method
Cmax (Maximum concentration of drug in serum)	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)	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 Outcome Measures

Name	Time	Method
AUC∞ (Area under the plasma concentration-time curve from time zero to infinity)	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
Cmax (Maximum concentration of drug in serum)	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
AUCt (Area under the plasma concentration-time curve from time zero to time t)	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
Dose normalized Cmax(Maximum concentration of drug in serum)	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
Dose normalized AUCt(Area under the plasma concentration-time curve from time zero to time t)	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
Dose normalized Tmax(Time of peak concentration)	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
Dose normalized AUC∞(Area under the plasma concentration-time curve from time zero to infinity)	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
Tmax (Time of peak concentration)	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of