Optimization of Therapeutic Drug Monitoring in Pediatric Kidney Transplant
Optimization of Therapeutic Drug Monitoring for Tacrolimus and Mycophenolate in Pediatric Kidney Transplant Recipients: a PK/PD Study
The goal of this observational, pharmacokinetic study is to evaluate factors that change drug exposure in pediatric kidney transplant recipients so investigators can make better dosing decisions. The main question it aims to answer is:
Can investigators quantify the impact of factors that change with time (like food intake and medication adherence) on tacrolimus and mycophenolate? Our hypothesis is that inconsistent drug and food intake will increase day to day variability in drug exposure, and investigators can use this information to help us make decisions about what is the best dose.
Participants will participate in the study on 7 days over the course of 1 year. On day 1, participants will be asked questions to see if participants are able to be in this study. Investigators will ask what immunosuppression participants are taking, how tall and how much participants weigh.
On day 2, participants and their parent/guardian will be taught how to use the device to collect the blood samples and decide on which days to collect them.
On days 3-6, participants will collect blood samples 4 separate times over about 1 year. Collection days should try to be scheduled every 3 months (+/- 2 weeks).
On each collection day, participants will collect a sample 7 different times over 9 hours. Each collection will only take approximately 5 minutes. Participants will be asked to collect a blood sample immediately before the morning dose of tacrolimus or mycophenolate, and 20 min, 1hr, 3hr, 4hr, 6hr, 9hr after the dose.
Also on collection days, participants will receive text messages and be asked to complete different assessments about their medications, diet, and how they feel by responding to the texts.
On day 7, participants will have the opportunity to participate in an interview where investigators will ask about participants' experience in the study.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Estimado)
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Recipient of a solid organ transplant and at least 1 year of age
- Receiving tacrolimus and/or mycophenolate
- Patient and/or caregiver is willing to receive text notifications and has a mobile device capable of receiving and sending text and multimedia messages.
- Ability to understand and willingness to sign a written informed consent
- Ability to understand, read, and speak English.
Exclusion Criteria:
- History of allergy to tape adhesives
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
|---|
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Longitudinal Self-Sampling for Immunosuppression Pharmacokinetics
Cohort of pediatric kidney transplant recipients self-collecting blood samples for assessment of intrapatient pharmacokinetic variability over 1 year
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Tacrolimus AUC
Periodo de tiempo: From enrollment for 1 year (samples every 3 months)
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Tacrolimus AUC (total exposure) will be estimated from the 7 tacrolimus blood concentrations using a population pharmacokinetic model
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From enrollment for 1 year (samples every 3 months)
|
|
Mycophenolic acid AUC
Periodo de tiempo: From enrollment for 1 year (samples collected every 3 months)
|
Mycophenolic acid AUC (total exposure) will be estimated from the 7 tacrolimus blood concentrations using a population pharmacokinetic model
|
From enrollment for 1 year (samples collected every 3 months)
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2026-0136
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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