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

NCT04102943 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-04-15

No results posted yet for this study

Summary

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

Conditions

  • Kidney Transplant

Interventions

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.

Sponsors & Collaborators

  • Chong Kun Dang Pharmaceutical

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-30
Primary Completion
2020-09-29
Completion
2020-09-29

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04102943 on ClinicalTrials.gov