NCT04102943

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Chong Kun Dang Pharmaceutical · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplant

Interventions

Type	Name	Description
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.
DRUG	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.

Timeline

• Start date: 2017-11-30
• Primary completion: 2020-09-29
• Completion: 2020-09-29
• First posted: 2019-09-25
• Last updated: 2026-04-15

Locations

1 site across 1 country: South Korea