UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059437 |
|---|---|
| Receipt number | R000067977 |
| Scientific Title | Effect of mineral corticoid receptor antagonist on vascular inflammation in hemophilia living with HIV |
| Date of disclosure of the study information | 2025/11/01 |
| Last modified on | 2025/10/16 20:54:32 |
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Basic information
Public title
Effect of mineral corticoid receptor antagonist on vascular inflammation in hemophilia living with HIV
Acronym
Hemophilia MRA Study
Scientific Title
Effect of mineral corticoid receptor antagonist on vascular inflammation in hemophilia living with HIV
Scientific Title:Acronym
Hemophilia MRA Study
Region
| Japan |
Condition
Condition
HIV
Hemophilia
Ischemic heart disease
Classification by specialty
| Cardiology | Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Demonstrating a reduction in the aortic-to-background 18F-FDG uptake ratio (TBR) on FDG-PET in hemophilia living with HIV treated with eplerenone
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Aortic and Background 18F-FDG uptake ratio (TBR) on FDG-PET before and after Eplerenone administration in hemophilia living with HIV
Key secondary outcomes
Inflammatory Markers (IL-6,TNFa, hs-CRP, sCD163, resistin, apelin) in hemophilia living with HIV before and after Eplerenone administration
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Eplerenone50mg once daily (initial 4 weeks), thereafter 50mg twice daily (total 100mg) for one year.Oral administration. Follow-up every 3 months.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
1) Patients who provided written consent to participate in the study
2) Males aged 20 years or older at the time of consent acquisition
3) Patients diagnosed with hemophilia
4) Patients with HIV infection
5) Patients with systolic blood pressure of 130 mmHg or higher, or who are taking antihypertensive medication
Key exclusion criteria
1) Patients with a history of hypersensitivity to Eplerenone
2) Patients with elevated serum potassium levels(K>5.0mEq/L)
3) Patients with severe renal dysfunction(eGFR<30ml/min)
4) Patients with severe liver dysfunction(Child-Pugh Class C cirrhosis)
5) Patients with receiving potassium-sparing diuretics MRAs
6) Patients with receiving Itraconazole,Ritonavir-containing formulations,and ensitrelvir fumarate
7) Patients with receiving potassium supplements
8) Those who are judged by the principal investigator to be inappropriate for inclusion in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yukio |
| Middle name | |
| Last name | Hiroi |
Organization
Japan Institute for Health Security
National Center for Global Health and Medicine
Division name
Cardiology
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
03-3202-7181
hiroi.y@jihs.go.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Hiroi |
Organization
Japan Institute for Health Security National Center for Global Health and Medicine
Division name
Cardiology
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
TEL
03-3202-7181
Homepage URL
hiroi.y@jihs.go.jp
Sponsor or person
Institute
Japan Institute for Health Security
Institute
Department
Personal name
Funding Source
Organization
Japan Institute for Health Security
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Institute for Health Security Comprehensive Research and Development Support Bureau Research Management Department Research Management Division Research Section
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo
Tel
03-3202-7181
rinrijm@jihs.go.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
| 2025 | Year | 11 | 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
| 2025 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 16 | Day |
Last modified on
| 2025 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067977
