Chronic Kidney DiseaseNCT07084038
Effect of Glycosuria on Urinary Protein in Patients With Chronic Kidney Disease Treated With SGLT2 Inhibitors
An observational study of Chronic Kidney Disease, run by Yuanjun Yang at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 30 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Glycosuria on Urinary Protein in Patients With Chronic Kidney Disease Treated With SGLT2 Inhibitor
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
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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).
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Jul 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuanjun Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuanjun Yang, Chinese PLA General Hospital
- Investigators
- Guangyan Cai, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084038
- Sponsor's protocol ID
- S2025-295-01
- Status last verified
- Jan 2025
- First submitted
- 22 Jul 2025
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glycosuria on Urinary Protein in Patients With Chronic Kidney Disease Treated With SGLT2 Inhibitor
- ClinicalTrials.gov ID
- NCT07084038
- Acronym / sponsor ID
- S2025-295-01
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Yuanjun YangUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guangyan Cai study director
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by Yuanjun Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage change in urinary protein from baseline at 3 months and 6 months of follow-up (time frame: 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2025.