NCT02356146|Unknown
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Sponsor study identifier
observational
60
1 country
1
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Tacrolimus dose highly varies among Asian kidney transplant recipients. This can be explained by variety of CYP3A5 expression. CYP3A5 genotyping is highly recommended for patients receiving tacrolimus. Here, we assessed the tacrolimus dose prediction by comparing CYP3A5 expression and tacrolimus dosage using tacrolimus concentration after single dose administration prior to kidney transplantation. Plasma tacrolimus trough level was measured at 12 hours after first dose of 0.1 mg/kg of tacrolimus (TacC12), orally administered in 51 new kidney transplant recipients. Patients with CYP3A5 inhibitor/inducer co-medications were excluded. Genotyping for CYP3A5 expression were carried out by RT-PCR. The dosages of tacrolimus at post-operative day 7 and dosage which provided stable therapeutic levels in post-operative month 1 to 3 (C0 5-8 ng/mL) were recorded. The genotyping, TacC12, and target tacrolimus dosage have good correlations.
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June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
February 1, 2015
Actual (reported)February 5, 2015
Actual (reported)April 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
target tacrolimus dose at 3 months
3 months
rate of rejection
3-12 months
rate of CNI toxicity
2-12 months
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All KT recipient who transplanted and will be transplanted in King Chulalongkorn Memorial Hospital from 2012-2015
Chulalongkorn University and King Chulalongkorn Memorial Hospital
Bangkok, 10330, Thailand
Blood level for tacrolimus was took 12 hours after first dose.
Natavudh Townamchai, MD
Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society
First Submitted
February 1, 2015
First Posted
February 5, 2015
Study Start
January 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2015
Safety and Efficacy of BiTE in Desensitization Therapy for Highly Sensitized Kidney Transplant Candidates With cPRA ≥ 90%
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2015
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
February 5, 2015
Record last verified: 2015-02
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Source: ClinicalTrials.gov.
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