Clinical trial NCT04102943: Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus in Kidney Transplant Recipients.
Official title: Single Center, Randomized, Open-label, Phase IV Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus Tablet(TacroBell) in Kidney Transplant Recipients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Transplant
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2019-09-25
Enrollment: 128
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cmax (Maximum concentration of drug in serum)
timeFrame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
measure: AUCt (Area under the plasma concentration-time curve from time zero to time t)
timeFrame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
Secondary outcomes:
measure: Tmax (Time of peak concentration)
timeFrame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
measure: AUC∞ (Area under the plasma concentration-time curve from time zero to infinity)
timeFrame: At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)
measure: Cmax (Maximum concentration of drug in serum)
timeFrame: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
measure: AUCt (Area under the plasma concentration-time curve from time zero to time t)
timeFrame: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
measure: Tmax (Time of peak concentration)
timeFrame: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
measure: AUC∞ (Area under the plasma concentration-time curve from time zero to infinity)
timeFrame: At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)
measure: Dose normalized Cmax(Maximum concentration of drug in serum)
timeFrame: 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)
measure: Dose normalized AUCt(Area under the plasma concentration-time curve from time zero to time t)
timeFrame: 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)
measure: Dose normalized Tmax(Time of peak concentration)
timeFrame: 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)
measure: Dose normalized AUC∞(Area under the plasma concentration-time curve from time zero to infinity)
timeFrame: 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)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: