Type 2 diabetic patients with overt nephropathy.
Conditions
Interventions
Control group based on conventional treatment.
Treatment group based on Kremezin 6g per day(sachet or capsule) added to conventional treatment.
Sponsors
Kanazawa Medical University Diabetes and Endocrinology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria. Type 2 diabetic patients with overt nephropathy and Patients that meet any of the following Inclusion Criteria may be enrolled into the study: 1) eGFR &#8805; 30mL/min/1.73 m2 and eGFR &#8804; 50mL/min/1.73 m2 and urinary albumin to urinary creatinine ratio &#8805; 300mg/g&#903;creatinine at the enrollment 2) Outpatient 3) Age &#8805; 20 years old and Age < 80 years old at the time of consent to participate in the study 4) Patients not required changes in anti-hypertensive medications or doses in the last 4 weeks prior to the enrollment 5) Patients being treated for hypertension(as anti-hypertensive regimen) Patients who fully understand purpose, contents, anticipated adverse events , and risks of this clinical trial and patients with willingness to comply with the study and sign a written informed consent
Exclusion criteria
Exclusion criteria: Exclusion Criteria Patients that meet any of the following Exclusion Criteria must not be enrolled into the study: 1) Patients with transit disorder in the digestive tract or peptic ulcer and esophageal varix (this product may irritate affected area.) and patients whom physician judges as inappropriate 2) Patients with a predisposition to severe and habitual constipation (this product may exacerbate constipation) and patients whom physician judges as inappropriate 3) Patients with severe ketosis, diabetic coma, or precoma 4) Patients with severe infection, before and after operation, or severe injury 5) Patients with hematuria 6) Patients with a previous history of medication allergy 7) Patients who is currently pregnant, or plan to become pregnant during the study period 8) Patients with active diabetic proliferative retinopathy (except for patients with proliferative retinopathy who conducted retinal photocoagulation therapy and were stable on the retina) 9) Patients whom physician determines as inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flow-mediated vasodilation(FMD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of estimated GFR by Japanese equation, urinary protein to urinary creatinine ratio, parameters related to vascular endothelial function and atherosclerosis (i.e., ADMA, NOx, vWF), NT-proBNP, uremic toxin (i.e., indoxyl sulfate), and oxidative stress(urinary 8-OHdG). | — |
Countries
Japan
Contacts
Public ContactDaisuke Koya
Kanazawa Medical University Hospital Endocrinolgy and Metabolism
Outcome results
None listed