Chronic Kidney Disease
Conditions
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.
Interventions
None listed
Sponsors
Yuanjun Yang
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percentage change in urinary protein from baseline at 3 months and 6 months of follow-up | 3 months and 6 months | The percentage change in urinary protein from baseline at 3 months and 6 months of follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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). |
Countries
China
Outcome results
None listed