Tokyo, Nov. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059437) titled 'Effect of mineral corticoid receptor antagonist on vascular inflammation in hemophilia living with HIV' on Nov. 1.
Study Type:
Interventional
Study Design:
Basic Design - Single arm
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Uncontrolled
Primary Sponsor:
Institute - Japan Institute for Health Security
Condition:
Condition - HIV
Hemophilia
Ischemic heart disease
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 20
years-old
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 Size - 20
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067977
Disclaimer: Curated by HT Syndication.
