UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061578 |
|---|---|
| Receipt number | R000069665 |
| Scientific Title | Minimization of maintenance immunosuppression in kidney transplant recipients based on both T and B cell epitope analysis |
| Date of disclosure of the study information | 2026/05/15 |
| Last modified on | 2026/05/14 19:04:38 |
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Basic information
Public title
Minimization (optimization) of maintenance immunosuppression in kidney transplant recipients based on both T and B cell epitope analysis
Acronym
Minimization of maintenance immunosuppression after kidney transplantation
Scientific Title
Minimization of maintenance immunosuppression in kidney transplant recipients based on both T and B cell epitope analysis
Scientific Title:Acronym
Minimization of maintenance immunosuppression in kidney transplant recipients based on epitope analysis
Region
| Japan |
Condition
Condition
Kidney transplantation
Classification by specialty
| Nephrology | Surgery in general | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Transplant recipients with favorable T cell epitope and B cell epitope compatibility (i.e., low eplet mismatch and PIRCHE score) were reported to have a significantly lower risk of immune responses leading to de novo DSA production. For such patients, we attempt to minimize and optimize immunosuppressive therapy. We confirm that no immune response is induced against the donor, specifically that no de novo DSA production is observed. For well-matched cases, we seek information on whether immunosuppressive therapy can be reduced. A large number of cases is required for the statistical analysis of a non-inferiority trial, therefore, this study will be conducted as a pilot trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
De novo DSA production status (Annual evaluation: covered by health insurance)
Key secondary outcomes
Kidney graft function (eGFR)
Presence of rejection (confirmed by kidney biopsy)
Onset of adverse events such as infections, hypertension, dyslipidemia, diabetes and malignancy
Graft failure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
The study will enroll patients with a very low risk of an immune response leading to de novo DSA production and favorable T-cell and B-cell epitope compatibility (i.e., low eplet mismatch and low PIRCHE score). Patients will be randomized to Reduction Group or Control (Maintenance) Group. In Reduction Group, we will attempt to minimize maintenance immunosuppressive therapy, that is, calcineurin inhibitor (tacrolimus or cyclosporine) will be reduced by one-third to one-half.
Interventions/Control_2
The study will enroll patients with a very low risk of an immune response leading to de novo DSA production and favorable T-cell and B-cell epitope compatibility (i.e., low eplet mismatch and low PIRCHE score). Patients will be randomized to Reduction Group or Control (Maintenance) Group. In Control Group (maintenance group), immunosuppressive therapy will remain unchanged.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 to 10 years post-transplant
Transplants performed in 2016 or later
Stable transplant kidney function (no change in transplant kidney function over the past 6 months)
Low B cell epitope mismatch (eplet MM (ver.3.1 antibody verified for DRB, DQB and DQA) is 4 or less) and low T cell epitope mismatch (PIRCHE-II score is 175 or less)
Key exclusion criteria
History of rejection episode
Sibling HLA haplotype identity (case of complete HLA haplotype match between siblings)
Donor specific HLA antibody (DSA)-positive transplantation
de novo DSA production
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takaaki |
| Middle name | |
| Last name | Kobayashi |
Organization
Aichi Medical University
Division name
Renal Transplant Surgery
Zip code
480-1195
Address
1-1, Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
takaaki.kobayashi@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Takaaki |
| Middle name | |
| Last name | Kobayashi |
Organization
Aichi Medical University
Division name
Renal Transplant Surgery
Zip code
480-1195
Address
1-1, Yazakokarimata, Nagakute, Aichi, Japan
TEL
0561-62-3311
Homepage URL
takaaki.kobayashi@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Takaaki Kobayashi
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital
Japanese Red Cross Kumamoto Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Aichi Medical University, Research Promotion Division, Research Support Section, Ethics Committee
Address
1-1, Yazakokarimata, Nagakute, Aichi, JAPAN
Tel
0561-62-3311
takaaki.kobayashi@aichi-med-u.ac.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
愛知医科大学病院（愛知県）
日本赤十字社愛知医療センター名古屋第二病院（愛知県）
熊本赤十字病院（熊本県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 15 | 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 | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069665
