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

NCT07084038 | Active Not Recruiting

• 1 other identifier: S2025-295-01
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

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

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

  3 months and 6 months

Secondary Outcomes (1)

• 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)

  3 months and 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged ≥18 years diagnosed with chronic kidney disease (CKD) at the First Medical Center of the PLA General Hospital by March 2026, who regularly received oral administration of standard-dose SGLT2 inhibitors (SGLT2i), will be included. Medical records and laboratory test results (including routine blood tests and blood biochemical parameters) will be collected. Changes in 24-hour urinary glucose and urinary protein levels from baseline will be observed at 3 and 6 months after SGLT2i administration.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yuanjun Yang: lead

Study Sites (1)

Chinese PLA General Hospital,

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Guangyan Cai

  Chinese PLA General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 24, 2025
• Study Start: July 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-01

Locations

CN (1)