Optimization of Therapeutic Drug Monitoring in Pediatric Kidney Transplant

NCT07769567 | Not Yet Recruiting

• 1 other identifier: 2026-0136
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Kidney Transplant

Keywords

tacrolimus; mycophenolate; pharmacokinetics; pediatrics; microsampling

Outcome Measures

Primary Outcomes (2)

• Tacrolimus AUC

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

  From enrollment for 1 year (samples every 3 months)

• Mycophenolic acid AUC

  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)

Study Arms (1)

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

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cincinnati Children's Hospital

You may qualify if:

• 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.

You may not qualify if:

• History of allergy to tape adhesives

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood microsamples

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 19, 2026

Record last verified: 2026-08