Level of MPA in pediatric kidney transplanted Infection
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Limited sampling stategies, pk parameters, Adverse events - Statistical analysis | — |
Countries
Thailand
Contacts
Pharmacology division, Faculty of Medisine Siriraj Hospital