Study to Evaluate the Pharmacokinetics and Tolerability of Tacrolimus in Kidney Transplant Recipients.
NCT ID: NCT04102943
Last Updated: 2020-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
128 participants
INTERVENTIONAL
2017-11-30
2021-01-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Tacrolimus1
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.
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.
Tacrolimus2
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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211KT17009
Identifier Type: -
Identifier Source: org_study_id
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