Pediatric Kidney TransplantationNCT07549230
Model-Informed Precision Dosing of Tacrolimus in Pediatric Kidney Transplantation
An observational study of Pediatric Kidney Transplantation, run by Helwan University.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Kidney Transplantation
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Child, Adult
Study population: Pediatric kidney recipients receiving tacrolimus
Who may be able to join
- 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.
Who cannot join
- Non-adherent patients to tacrolimus.
- Unavailable or missing data.
About this study
Official title: Model-Informed Precision Dosing of Tacrolimus in Pediatric Kidney Transplantation: A Hybrid Population Pharmacokinetics-Machine Learning Approach
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.
- Conditions
- Pediatric Kidney Transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: June 2026 - January 2027
Secondary outcomes (1)
Reduction in the risk of acute graft rejection.
Reduction in the risk of acute graft rejection by developing a clinical decision support tool (CDST) to guide the dose individualization of tacrolimus following pediatric kidney transplantation.
Measured: June 2026 - January 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Sondos Mohamed Salem, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07549230
- Sponsor's protocol ID
- HU-FP-CP-2026-001
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Model-Informed Precision Dosing of Tacrolimus in Pediatric Kidney Transplantation: A Hybrid Population Pharmacokinetics-Machine Learning Approach
- ClinicalTrials.gov ID
- NCT07549230
- Acronym / sponsor ID
- HU-FP-CP-2026-001
- Conditions
- Pediatric Kidney Transplantation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Pediatric kidney recipients receiving tacrolimus
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Non-adherent patients to tacrolimus.
- Unavailable or missing data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of a novel and applicable dosing algorithm.
Time frame: June 2026 - January 2027
A dosing algorithm that rapidly achieves accurate tacrolimus levels within the optimal immunosuppression range despite sparse sampling in routine clinical practice.
1 secondary outcome
Reduction in the risk of acute graft rejection.
Time frame: June 2026 - January 2027
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Kidney Transplantation, run by Helwan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a novel and applicable dosing algorithm. (time frame: June 2026 - January 2027). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.