UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061408 |
|---|---|
| Receipt number | R000070253 |
| Scientific Title | A Prospective Study Characterizing Patterns of Discrepancies Between Predicted and Observed Initial Tacrolimus Dosing in a CYP3A5 Genotype-Based Model. |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/28 19:43:38 |
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Basic information
Public title
A Prospective Study Investigating Predictability and Discrepancies in Initial Tacrolimus Dosing Using Genetic Information.
Acronym
TAC-PRED Study
Scientific Title
A Prospective Study Characterizing Patterns of Discrepancies Between Predicted and Observed Initial Tacrolimus Dosing in a CYP3A5 Genotype-Based Model.
Scientific Title:Acronym
TAC-PRED Study
Region
| Japan |
Condition
Condition
Immunosuppressive therapy (tacrolimus dosing) in kidney transplant recipients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to characterize discrepancies between predicted and observed tacrolimus concentrations in a CYP3A5 genotype-based initial dosing model and to identify their clinical patterns.
Basic objectives2
Others
Basic objectives -Others
To descriptively analyze the magnitude and patterns of discrepancies between predicted and observed values in a CYP3A5 genotype-based initial tacrolimus dosing model.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Discrepancy between predicted and observed tacrolimus trough concentrations measured on the morning of day 4 before the fourth dose.
Key secondary outcomes
Base
Study type
Observational
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing kidney transplantation who initiate tacrolimus-based immunosuppressive therapy and provide informed consent for participation.
Key exclusion criteria
Patients in whom tacrolimus trough concentrations cannot be measured on the morning of day 4 before the fourth dose, or those deemed inappropriate for inclusion by the investigator.
Target sample size
74
Research contact person
Name of lead principal investigator
| 1st name | Sumi |
| Middle name | |
| Last name | Hidaka |
Organization
Shonan Kamakura General Hospital, Tokushukai Medical Corporation
Division name
Kidney Disease and Transplant Center
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura-shi, Kanagawa, Japan
TEL
0467-46-1717
s_hidaka@shonankamakura.or.jp
Public contact
Name of contact person
| 1st name | Junko |
| Middle name | |
| Last name | Horiuchi |
Organization
Shonan Kamakura General Hospital, Tokushukai Medical Corporation
Division name
General Affairs Department
Zip code
247-8533
Address
1370-1 Okamoto, Kamakura-shi, Kanagawa, Japan
TEL
0467-46-1717
Homepage URL
j_horiuchi@shonankamakura.or.jp
Sponsor or person
Institute
Shonan Kamakura General Hospital, Tokushukai Medical Corporation
Institute
Department
Personal name
Funding Source
Organization
Shonan Kamakura General Hospital, Tokushukai Medical Corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokushukai Group Central Institutional Review Board
Address
1-3-1 Kudan-minami, Chiyoda-ku, Tokyo, Japan
Tel
03-3263-4801
mirai-ec1@mirai-iryo.com
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 | 05 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective single-arm study in which the initial tacrolimus dose is determined using a model developed based on CYP3A5 genotype. Tacrolimus trough concentrations are measured on the morning of day 4 before the fourth dose, and discrepancies between predicted and observed values are evaluated.
Management information
Registered date
| 2026 | Year | 04 | Month | 28 | Day |
Last modified on
| 2026 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070253
