Exploration of Clinical Indicators of Renal Dysfunction in Japanese Adult Male and Female -A cross-sectional study
- Conditions
- ormal subjects and those with reduced renal function or renal impairment
- Registration Number
- JPRN-UMIN000053010
- Lead Sponsor
- FANCL Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 150
Not provided
1) Subjects on renal dialysis or after renal transplantation. 2) Subjects with one or more diagnoses of hereditary kidney diseases, primary kidney diseases, hepatitis virus-related nephropathies or drug-induced kidney diseases. 3) Subjects with serious illnesses such as malignancy, severe heart failure, cirrhosis, chronic kidney disease or acute deterioration of complications. 4) Subjects with a history of surgery, severe infection or trauma or burns within 3 months. 5) Subjects who have changed the type or dose of a therapeutic drug affecting the study within 3 months. 6) Subjects treated with immunosuppressive drugs or steroids within 6 months 7) Subjects with symptomatic hypotension or systolic blood pressure < 90 mg 8) Subjects with type 1 diabetes mellitus or a history of severe hypoglycaemia. 9) Subjects with inborn errors of amino acid metabolism. 10) Subjects who regularly use food fortified with specified amino acids. 11) Subjects who are pregnant or lactating. 12) Subjects who have participated in other clinical trials within 1 month or will participate during this study. 13) Subjects judged as unsuitable for the study by the responsible doctor for other reasons.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Biomarkers of renal dysfunction, Oxidative stress markers, inflammatory markers
- Secondary Outcome Measures
Name Time Method