Effect of Glycosuria on Urinary Protein in Patients With Chronic Kidney Disease Treated With SGLT2 Inhibitors

This trial aims to investigate the correlation between glycosuria levels and urinary protein in chronic kidney disease patients treated with Sodium-Glucose Transporter 2 Inhibitors(SGLT2i), and to explore whether glycosuria can reflect the therapeutic response to SGLT2i in these patients. Through this study, the investigators hope to provide some clinical references for optimizing SGLT2i dosing strategies.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital,

Beijing, Beijing Municipality, 100853, China

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥18 years. Patients with a confirmed diagnosis of chronic kidney disease (CKD). Currently receiving stable, standard-dose SGLT2i therapy at screening. Proteinuria ≥0.15 g/24 h (or urine protein-to-creatinine ratio [UPCR] ≥440 mg/g or urine albumin-to-creatinine ratio [UACR] ≥300 mg/g) at screening.

Estimated glomerular filtration rate (eGFR) ≥15 mL/min/1.73m² calculated by the CKD-EPI creatinine equation at screening.

Willing and able to provide written informed consent.

Exclusion criteria

Discontinuation of SGLT2i during the follow-up period. History of symptomatic hypotension (systolic blood pressure<90 mmHg) without antihypertensive medication, or current hypotensive episode at screening.

Unstable renal function (e.g., acute kidney injury or rapidly progressive glomerulonephritis with a >50% decline in eGFR within 3 months prior to screening).

Use of corticosteroids or having an indication for corticosteroid therapy within the past 6 months.

Receipt of immunosuppressive therapy or having an indication for immunosuppressive therapy within the past 6 months.

History of intolerance to SGLT2 inhibitors. History of ketoacidosis within the past 5 years.

Treatment and study plan

Primary outcomes

The percentage change in urinary protein from baseline at 3 months and 6 months of follow-up

Time frame: 3 months and 6 months

The percentage change in urinary protein from baseline at 3 months and 6 months of follow-up

Secondary outcomes

The proportion of a 50% reduction in urinary protein, the proportion of a 30% reduction in urinary protein, and the changes in estimated glomerular filtration rate (eGFR)

Time frame: 3 months and 6 months

The proportion of patients with a 50% reduction in urinary protein and a 30% reduction in urinary protein at 3 months and 6 months of follow-up, as well as the percentage change in estimated glomerular filtration rate (eGFR).

Sponsors and collaborators

Lead sponsor

Yuanjun Yang

Other

Registry information

Official study title

Effect of Glycosuria on Urinary Protein in Patients With Chronic Kidney Disease Treated With SGLT2 Inhibitor

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jul 24, 2025
Registry last updated: Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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