UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063067 |
|---|---|
| Receipt number | R000072196 |
| Scientific Title | Safety, Adverse Events, and Pharmacokinetics/Therapeutic Drug Monitoring of Sirolimus in Infants Under One Year of Age: A Scoping Review |
| Date of disclosure of the study information | 2026/09/28 |
| Last modified on | 2026/09/28 03:24:44 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Safety, Adverse Events, and Pharmacokinetics/Therapeutic Drug Monitoring of Sirolimus in Infants Under One Year of Age: A Scoping Review
Acronym
Safety, Adverse Events, and Pharmacokinetics/Therapeutic Drug Monitoring of Sirolimus in Infants Under One Year of Age: A Scoping Review
Scientific Title
Safety, Adverse Events, and Pharmacokinetics/Therapeutic Drug Monitoring of Sirolimus in Infants Under One Year of Age: A Scoping Review
Scientific Title:Acronym
Scoping Review of Sirolimus in Infants under 1 year of Age
Region
| Japan |
Condition
Condition
Diseases requiring sirolimus administration in infants under 1 year of age (e.g., vascular malformations, tuberous sclerosis, lymphatic anomalies)
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To conduct a scoping review of existing literature to comprehensively evaluate the safety, adverse events, tolerability, dosage, pharmacokinetic (PK) parameters, and therapeutic drug monitoring (TDM) data of sirolimus in infants under 1 year of age (including preterm and newborn infants).
Basic objectives2
Others
Basic objectives -Others
Scoping review (mapping and evaluation of literature on safety, pharmacokinetics, etc.)
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Safety and incidence of adverse events associated with sirolimus (throughout the literature search period)
Key secondary outcomes
Tolerability, dosage, pharmacokinetic (PK) parameters, and therapeutic drug monitoring (TDM) data (e.g., trough levels) (throughout the literature search period)
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 1 | days-old | <= |
Age-upper limit
| 1 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Infants under 1 year of age (including preterm and newborn infants). For studies targeting a broader pediatric population, only those with extractable individual data for infants under 1 year are included.
2 Administration of sirolimus (rapamycin) with evaluation of safety, adverse events (AEs), tolerability, dosage, pharmacokinetic (PK) parameters, or therapeutic drug monitoring (TDM) data (e.g., trough levels).
3 Any clinical setting regardless of underlying condition or indication (e.g., vascular malformations, tuberous sclerosis, lymphatic anomalies, off-label use).
4 Study designs: Case reports, case series, observational studies, non-randomized interventional studies, and randomized controlled trials (RCTs).
Key exclusion criteria
1 Preclinical studies (animal models and in vitro experiments).
2 Review articles without primary data.
3 Conference abstracts without available full text.
Target sample size
0
Research contact person
Name of lead principal investigator
| 1st name | Osuke |
| Middle name | |
| Last name | Iwata |
Organization
Nagoya City University
Division name
Department of Pediatrics and Neonatology, Nagoya City University Graduate School of Medical Sciences
Zip code
467-8602
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-851-5511
yasu_69125316715@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Osuke |
| Middle name | |
| Last name | Iwata |
Organization
Nagoya City University
Division name
Department of Pediatrics and Neonatology, Nagoya City University Graduate School of Medical Sciences
Zip code
467-8602
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
TEL
052-851-5511
Homepage URL
yasu_69125316715@yahoo.co.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi
Tel
052-851-5511
yasu_69125316715@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2026 | Year | 08 | Month | 28 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a scoping review of existing literature regarding the safety, adverse events, dosage, pharmacokinetic parameters, and therapeutic drug monitoring of sirolimus in infants under 1 year of age.
Management information
Registered date
| 2026 | Year | 09 | Month | 28 | Day |
Last modified on
| 2026 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072196
