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

NCT04102943 | Completed Phase 4

• 1 other identifier: 211KT17009
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Kidney Transplant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Tmax (Time of peak concentration)

  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)

  At 2weeks predose(0hour)and dose(0.5,1,1.5,2,3,4,8,12hours)

• Cmax (Maximum concentration of drug in serum)

  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)

  At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)

• Tmax (Time of peak concentration)

  At 24weeks predose(0hour)and dose(0.5,1,1.5,2,3,4hours)

Study Arms (2)

Tacrolimus1

EXPERIMENTAL

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

Tacrolimus2

ACTIVE COMPARATOR

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

Interventions

tacrolimus tablet DRUG

* 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.

Also known as: tacrobell tablet

Tacrolimus1

tacrolimus capsules DRUG

* 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.

Also known as: prograf capsules

Tacrolimus2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2019
• First Posted: September 25, 2019
• Study Start: November 30, 2017
• Primary Completion: September 29, 2020
• Study Completion: September 29, 2020
• Last Updated: April 15, 2026

Record last verified: 2022-03

Locations

KR (1)