The correlation of area under the curve with single time point concentration of mycophenolic acid and its metabolite in Thai kidney transplant recipients receiving enteric-coated mycophenolate sodium

Phase 2

Completed

• Conditions: Thai kidney transplant recipients; Enteric- coated mycophenolate sodium, Pharmacokinetics, Single time point concentration

• Registration Number: TCTR20190326003
• Lead Sponsor: The 90th Anniversary of Chulalongkorn University, Rachadapisek Sompote Fund.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-26
• Study Completion: 2019-08-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Aged 18 years or older.
Kidney transplant
Who had received EC-MPS + tacrolimus + prednisolone

Exclusion Criteria

Patients with multiple organ transplantation
Patients who are taking concomitant drug that might have drug interaction such as antacid, antibiotic and high protein binding drug.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
single time point concentration of MPA and its metabolite 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 10 and 12 hr plasma/ measure by LC-MS/MS

Secondary Outcome Measures

Name	Time	Method
cut-off point concentration of MPA for indicating MPA exposure more than 30 µg•h/l - ROC curve