Therapeutic drug monitoring of mycophenolic acid and validation of limited sampling strategies for the estimation area under the mycophenolic acid concentration-time curve in Thai pediatric renal transplant recipients at Siriraj hospital
- Conditions
- evel of MPA in pediatric kidney transplantedInfection
- Registration Number
- TCTR20170206004
- Lead Sponsor
- Faculty of Medicine Siriraj Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 25
1. Renal transplant recipients who aged under 18 years old
2. Renal recipient who underwent transplantation for at least 3 months and follow-up at Siriraj hospital
3. Renal recipient who on stable dose of MPA (MMF or EC-MPS) for at least 1 week
4. Renal recipient who voluntarily given consent to participate the study by their parents or caregiver and additional assent for children 7-18 years old
1.Renal recipient who has hematological abnormalities within 3 months:
- Hemoglobin < 5 gm/dl, or
- Platelet < 100,000 cell/mm3
2.Renal recipient who has concomitant drug use which might change the PK properties of MPA such as omeprazole, metronidazole, norfloxacin, pantoprazole, rifampin, antacids, cholestyramine, rabeprazole, esomeprazole, lansoprazole, dexlansoprazole, colestipol, colesevelam, activated charcoal, cyclosporine
3.Renal recipient who has condition that affect PK od MPA such as gastrointestinal diseases, liver dysfunction
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mycophenolic acid area under concentration-time curve 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12 after dosng Plasma/ measure by UPLC/PDA
- Secondary Outcome Measures
Name Time Method imited sampling stategies, pk parameters, Adverse events - Statistical analysis