None listed
Conditions
Interventions
TM5614 is started as 2 tablets (120 mg) once daily (4 weeks) and increased to 3 tablets (180 mg) once daily (12 weeks) if blood and biochemical tests after 1 month show no safety issues
Sponsors
Harigae Hideo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Over 50 years old and under 75 years old 2)Patients diagnosed with one or more of the following diseases based on the definitions in the clinical guidelines and whose symptoms are stable: hypertension (The Japanese Society of Hypertension Guidelines for the Management of Hypertension 2019), type 2 diabetes (Japanese Clinical Practice Guideline for Diabetes 2024), chonic kidney disease (Clinical Practice Guideline for CKD 2023), hyperlipidemia (Japan Atherosclerosis Society (JAS) guidelines for prevention of atherosclerotic cardiovascular diseases 2022) 3)Patients who have obtained written consent from the individual to participate in this study
Exclusion criteria
Exclusion criteria: 1) Patients who are taking or receiving any of the following medications: Warfarin potassium, Dabigatran etexilate methanesulfonate, and Rivaroxaban, Apixaban, Edoxaban Tosilate Hydrate, heparin and tissue-type plasminogen activator 2) Hypertensive patients with systolic blood pressure of 180 mmHg or higher and diastolic blood pressure of 110 mmHg or higher (so-called grade III hypertension) 3) Chronic kidney disease patients with eGFR less than 30 ml/min/1.73 m2 4) Patients with type 2 diabetes mellitus who are on insulin therapy and hospitalized 5) Familial hypercholesterolemia among hyperlipidemic patients 6) Patients who are participating in other clinical trials 7) Patients undergoing cancer treatment 8) Patients with autoimmune diseases 9) Patients with a history of transient ischemic attack or cerebral vascular attack within 180 days prior to enrollment in this study 10) Patients participating in other interventional trials 11) Patients with the following cardiovascular Diseases -Have a history of myocardial infarction within 6 months prior to enrollment -Symptomatic arrhythmia requiring treatment -Have a history of severe thrombosis or thromboembolism such as pulmonary arterial embolism or deep vein thrombosis. However, those who have not had a history of thrombosis or thromboembolism for at least 90 days and have no concerns about recurrence may be enrolled. 12) Patients with a history of bleeding, such as intracerebral hemorrhage 13) Liver function and renal function test values are as follows: -AST and ALT are more than 3 times the upper limit of the reference value of the institution -Total bilirubin is more than 2 times the upper limit of the reference value of the institution -Creatinine is more than 1.5 mg/dL or creatinine clearance (measured value or estimated value by Cockcroft/Gault formula) is less than 45 mL/min or less 14) Patients received radiation therapy within 28 days prior to enrollment in this study 15) Patients have bleeding tendency 16) Patients are pregnant, lactating or may be pregnant 17) Patients have a systemic infection requiring treatment 18) Patients requiring transplantation therapy or those with a history of transplantation therapy (excluding autologous transplantation) 19) Patients who are judged to lack the capacity to consent due to complications of dementia 20) Other patients who are judged to be ineligible for this study by the principal (sub)investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation by FACS of surface markers of immune cells and their degrees of expression | — |
Secondary
| Measure | Time frame |
|---|---|
| Aging markers -Senescence-associated small RNA (SA miRNA) screening: Quantification of SA miRNA in patient serum, plasma, peripheral blood lymphocytes (PBL), and T cells -G tail telomere hybridization protection Assay (Gt telomere HPA): evaluation of G-tail and telomere length in PBLs that shorten with age-related diseases and cellular senescence -Quantification of SA gene fragments in patient plasma -DNA methylation Stem Cells -Evaluation of phenotypic markers and frequencies of HSCs and blood cells by FACS -Evaluation of effects on the transcriptome by isolating HSCs and performing RNA-seq analysis -Evaluation of effects on clonal hematopoiesis by exome analysis using peripheral blood differentiated blood cells (samples with drug effects found in 1) and 2) above) Immunology and Metabolism -SomaScan 11K Assay (serum senescence-related secretory phenotype) -Senescence status and biological activities of total CD4 T cells (telomerase activity, telomere length, cell proliferation activity, cell death, gene expression) -Monocyte-derived macrophages (MDM) Biological activities of monocyte-derived macrophages (MDM) (glucose uptake capacity, mitochondrial function, ROS production, beta-galactosidase staining, gene expression) -Modomics analysis of RNA-derived modified nucleosides in serum (related to mitochondrial activity and inflammatory response) -Metallomics analysis of trace elements in serum | — |
Contacts
Public ContactHiroshi Fujii
Tohoku University Hospital
Outcome results
None listed