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OpenTrials
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NCT Number: NCT07769567

Optimization of Therapeutic Drug Monitoring in Pediatric Kidney Transplant

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.

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Key information

Conditions

Age range

1 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Tacrolimus AUC

    Time frame: From enrollment for 1 year (samples every 3 months)

    Tacrolimus AUC (total exposure) will be estimated from the 7 tacrolimus blood concentrations using a population pharmacokinetic model

  2. Mycophenolic acid AUC

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

Optimization of Therapeutic Drug Monitoring for Tacrolimus and Mycophenolate in Pediatric Kidney Transplant Recipients: a PK/PD Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 18, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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