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

Chong Kun Dang

Status and phase: Unknown; Phase 4

Conditions: Kidney Transplant

Treatments: Drug: tacrolimus capsules; Drug: tacrolimus tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT04102943

211KT17009

Details and patient eligibility

About

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

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

Tacrolimus1

Experimental group

Description:

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.

Treatment:

Drug: tacrolimus tablet

Tacrolimus2

Active Comparator group

Description:

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.

Treatment:

Drug: tacrolimus capsules