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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. 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
Information provided by (Responsible Party):
Natavudh Townamchai, MD, Chulalongkorn University

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Group/Cohort Intervention/treatment
All KT recipient Drug: Tacrolimus C12

Primary Outcome Measures :
  1. target tacrolimus dose at 3 months [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. rate of rejection [ Time Frame: 3-12 months ]
  2. rate of CNI toxicity [ Time Frame: 2-12 months ]

Biospecimen Retention:   Samples Without DNA
Blood level for tacrolimus was took 12 hours after first dose.

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All KT recipient who transplanted and will be transplanted in King Chulalongkorn Memorial Hospital from 2012-2015

Inclusion Criteria:

  • All KT recipients

Exclusion Criteria:

  • Recipient who not receiving tacrolimus

Information from the National Library of Medicine

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 identifier (NCT number): NCT02356146

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Contact: Natavudh Townamchai, MD +66894904222

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Chulalongkorn University and King Chulalongkorn Memorial Hospital Recruiting
Bangkok, Thailand, 10330
Contact: Natavudh Townamchai, MD    +66894904222   
Sponsors and Collaborators
Chulalongkorn University
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Principal Investigator: Natavudh Townamchai, MD Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society

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Responsible Party: Natavudh Townamchai, MD, Assistant Professor, Chulalongkorn University Identifier: NCT02356146     History of Changes
Other Study ID Numbers: IRB225/56
First Posted: February 5, 2015    Key Record Dates
Last Update Posted: February 5, 2015
Last Verified: February 2015

Keywords provided by Natavudh Townamchai, MD, Chulalongkorn University:
Kidney transplantation

Additional relevant MeSH terms:
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Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action