First Tacrolimus Dose Trough Level is Better Than CYP3A5 Genotyping in Tacrolimus Dose Prediction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02356146|
Recruitment Status : Unknown
Verified February 2015 by Natavudh Townamchai, MD, Chulalongkorn University.
Recruitment status was: Recruiting
First Posted : February 5, 2015
Last Update Posted : February 5, 2015
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.
|Condition or disease||Intervention/treatment|
|Kidney Transplantation Recipients||Drug: Tacrolimus C12|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||First Tacrolimus Dose Trough Level is Better Than CYP3A5 Genotyping in Tacrolimus Dose Prediction|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||April 2015|
|Estimated Study Completion Date :||June 2015|
|All KT recipient||
Drug: Tacrolimus C12
- target tacrolimus dose at 3 months [ Time Frame: 3 months ]
- rate of rejection [ Time Frame: 3-12 months ]
- rate of CNI toxicity [ Time Frame: 2-12 months ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02356146
|Contact: Natavudh Townamchai, MDfirstname.lastname@example.org|
|Chulalongkorn University and King Chulalongkorn Memorial Hospital||Recruiting|
|Bangkok, Thailand, 10330|
|Contact: Natavudh Townamchai, MD +66894904222 email@example.com|
|Principal Investigator:||Natavudh Townamchai, MD||Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society|