Exploration of Clinical Indicators of Renal Dysfunction in Japanese Adult Male and Female -A cross-sectional study

Exploration of Clinical Indicators of Renal Dysfunction in Japanese Adult Male and Female -A cross-sectional study - Exploration of Clinical Indicators of Renal Dysfunction in Japanese Adult Male and Female

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000053010

Enrollment

150

Registered

2023-12-06

Start date

2023-12-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Normal subjects and those with reduced renal function or renal impairment

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects with renal impairment or impaired renal function 1) Japanese male and female aged 40 years or older at the time of consent. 2) Subjects with eGFRcreat < 60 ml/min/1.73 m2 or urinary albumin/Cr ratio of 30 mg/gCr or more. Controls 1) Japanese male and female aged 40 years or older at the time of consent. 2) Subjects with no renal impairment, impaired renal function or abnormal urinalysis.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
Biomarkers of renal dysfunction, Oxidative stress markers, inflammatory markers	—

Countries

Japan

Contacts

Public ContactReiko Naito

Kenkoin Medical Corporation Foundation Kenkoin Clinic

reiko-naito@kenkoin.jp03-3573-1153

Outcome results