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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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Observational
Source
TCTR
Registry ID
TCTR20170206004
Enrollment
25
Registered
2017-02-06
Start date
2017-05-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Level of MPA in pediatric kidney transplanted Infection

Interventions

Pediatric patients who have kidney transplantation and on stable with mycophenolic acid dose
Health Services Research
Pediatric KTX with MPA

Sponsors

Faculty of Medicine Siriraj Hospital
Lead Sponsor
Mahidol university
Collaborator

Eligibility

Sex/Gender
All
Age
0 Years to 18 Years

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: &#45; Hemoglobin < 5 gm/dl&#44; or &#45; Platelet < 100&#44;000 cell/mm3 2. Renal recipient who has concomitant drug use which might change the PK properties of MPA such as omeprazole&#44; metronidazole&#44; norfloxacin&#44; pantoprazole&#44; rifampin&#44; antacids&#44; cholestyramine&#44; rabeprazole&#44; esomeprazole&#44; lansoprazole&#44; dexlansoprazole&#44; colestipol&#44; colesevelam&#44; activated charcoal&#44; cyclosporine 3. Renal recipient who has condition that affect PK od MPA such as gastrointestinal diseases&#44; liver dysfunction

Design outcomes

Primary

MeasureTime frame
Mycophenolic acid area under concentration&#45;time curve 0&#44; 0.5&#44; 1&#44; 1.5&#44; 2&#44; 2.5&#44; 3&#44; 4&#44; 6&#44; 8&#44; 12 after dosng Plasma/ measure by UPLC/PDA

Secondary

MeasureTime frame
Limited sampling stategies&#44; pk parameters&#44; Adverse events &#45; Statistical analysis

Countries

Thailand

Contacts

Public ContactWeerawadee Chandranipapongse

Pharmacology division&#44; Faculty of Medisine Siriraj Hospital

weerawadee.cha@mahidol.ac.th081-625-9011

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026