NCT07549230

Brief Summary

The purpose of this study is to develop a novel and applicable dosing algorithm that helps support the clinical decision to achieve tacrolimus levels within the optimal immunosuppression range despite sparse sampling in routine clinical practice in pediatric kidney transplantation. This clinical decision support tool (CDST) is based on a hybrid population pharmacokinetics-machine learning approach aiming for tacrolimus dose individualization and reducing the risk of acute graft rejection.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
12mo left

Started Jun 2026

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 15, 2026

Last Update Submit

April 23, 2026

Conditions

Pediatric Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Development of a novel and applicable dosing algorithm.

    A dosing algorithm that rapidly achieves accurate tacrolimus levels within the optimal immunosuppression range despite sparse sampling in routine clinical practice.

    June 2026 - January 2027

Secondary Outcomes (1)

  • Reduction in the risk of acute graft rejection.

    June 2026 - January 2027

Eligibility Criteria

AgeUp to 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric kidney recipients receiving tacrolimus

You may qualify if:

  • Pediatric patients (\< 18 years old).
  • First-time kidney transplant recipients who have less than 20% PRA and no DSA.
  • Adherent to tacrolimus for a year post-transplantation.
  • All data, including therapeutic drug monitoring (TDM) data, are available.

You may not qualify if:

  • Non-adherent patients to tacrolimus.
  • Unavailable or missing data.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

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

Study Record Dates

First Submitted

April 15, 2026

First Posted

April 24, 2026

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 29, 2026

Record last verified: 2026-04