Kidney Disease, ChronicNCT05033054
Effect of SGLT2i on Cardiovascular Biomarkers in Patients With Type 2 Diabetes and CKD Stage 3b-4
An observational study of Kidney Disease, Chronic and Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This is a prospective, observational study to assess the effect of SGLT2 inhibitors on surrogate markers of kidney and cardiovascular health in patients with stage 3b and 4 chronic kidney disease (CKD). This study includes three clinic in person visits and weekly telephone visits for 12 weeks. 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Disease, Chronic, Diabetes
- What is being tested?
- SGLT2 inhibitor
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 1 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with type 2 diabetes mellitus and stage 3b-4 chronic kidney disease.
Who may be able to join
- 18-80 years of age
- All races and ethnicities
- All genders
- Type 2 diabetes mellitus
- History of hypertension defined as > 130 or > 80 mmHg or normotensive on pharmacologic therapy
- Estimated glomerular filtration rate (GFR) (CKD Epi equation) of 15-44 ml/min/1.73 m2 (Stages 3b-4 CKD)
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- Urinary albumin creatinine ratio of > 200 mg/g <5000mg/g
- Ability of study participant or legally authorized representative to provide informed written consent
- Able to maintain stable dose of any vitamin D and any calcium supplements for 180 days post randomization.
Who cannot join
- Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
- Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
- History of organ transplantation
- Receiving therapy with a sodium glucose co-transporter 2 (SGLT2) inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
- Type 1 diabetes (T1D)
- Active use of SGLT2 inhibitor
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- History of persistent hypercalcemia (serum total Calcium > 10.5 mg/dl)
- Body mass index > 45 kg/m2
- Active on kidney transplant list
- Inability to provide informed consent
- Any condition outside the renal and cardiovascular disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator´s clinical judgement
- Active malignancy requiring treatment at the time of screening (with the exception of successfully treated basal cell or treated squamous cell carcinoma).
- Hepatic impairment (aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment)
- Women of child-bearing potential (ie, those who are not chemically or surgically sterilized or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator or women who have a positive pregnancy test at enrolment or randomization or women who are breast-feeding
- Participation in another clinical study with an investigational product (IP) during the last month prior to Enrolment
- Inability of the patient, in the opinion of the investigator, to understand and/or comply with procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study. Patients who cannot complete the patient reported outcome (PRO) assessments can still participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, observational study to assess the effect of SGLT2 inhibitors on surrogate markers of kidney and cardiovascular health in patients with stage 3b and 4 chronic kidney disease (CKD).
This study includes three clinic in person visits and weekly telephone visits for 12 weeks.
- Recruit 28 patients with CKD stages 3b-4 and follow up for 12 weeks
- Determine the effect of interventions on the primary outcome variable serum klotho measured by immunoprecipitation-immunoblot
- Conditions
- Kidney Disease, Chronic, Diabetes
- Being tested
- SGLT2 inhibitor
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT2 inhibitorDrug
Participants will ingest a standard dose of SGLT2i prescribed by the standard of care physician.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group 1: take prescribed SGLT2i after baseline visit. Receives: Drug: SGLT2 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum klotho levels at 6 weeks
Change in serum klotho levels in participants with advanced Diabetic Kidney Disease (DKD) at 6 weeks are measured by immunoprecipitation-immunoblot.
Measured: Baseline, 6 weeks
Change in serum klotho levels at 12 week
Change in Serum klotho levels in participants with advanced Diabetic Kidney Disease (DKD) at 12 weeks are measured by immunoprecipitation-immunoblot.
Measured: Baseline, 12 weeks
Secondary outcomes (2)
Change in serum magnesium levels at 6 weeks
Mean change from baseline in serum magnesium levels at 6 weeks is measured. Serum magnesium levels are measured by measuring the level of magnesium in the blood.
Measured: Baseline, 6 weeks
Change in serum magnesium levels at 12 weeks
Mean change from baseline in serum magnesium levels at 12 weeks is measured. Serum magnesium levels are measured by measuring the level of magnesium in the blood.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2021
- Study start1 Jan 2022
- Primary completion2 Jan 2025
- Study completion1 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Disease, ChronicStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Toto, University of Texas Southwestern Medical Center
- Investigators
- Robert Toto, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05033054
- Sponsor's protocol ID
- STU-2021-0492
- Status last verified
- Jul 2025
- First submitted
- 26 Aug 2021
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of SGLT2i on Cardiovascular Biomarkers in Patients With Type 2 Diabetes and CKD Stage 3b-4
- ClinicalTrials.gov ID
- NCT05033054
- Acronym / sponsor ID
- STU-2021-0492
- Conditions
- Kidney Disease, Chronic, Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 2 Jan 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 2 Sep 2021 (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 is a prospective, observational study to assess the effect of SGLT2 inhibitors on surrogate markers of kidney and cardiovascular health in patients with stage 3b and 4 chronic kidney disease (CKD).
This study includes three clinic in person visits and weekly telephone visits for 12 weeks.
- Recruit 28 patients with CKD stages 3b-4 and follow up for 12 weeks
- Determine the effect of interventions on the primary outcome variable serum klotho measured by immunoprecipitation-immunoblot
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: SGLT2 inhibitorGroup 1: take prescribed SGLT2i after baseline visit. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with type 2 diabetes mellitus and stage 3b-4 chronic kidney disease.
Key inclusion criteria (9 listed)
- 18-80 years of age
- All races and ethnicities
- All genders
- Type 2 diabetes mellitus
- History of hypertension defined as > 130 or > 80 mmHg or normotensive on pharmacologic therapy
Key exclusion criteria (16 listed)
- Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis
- Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment
- History of organ transplantation
- Receiving therapy with a sodium glucose co-transporter 2 (SGLT2) inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
- Type 1 diabetes (T1D)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGLT2 inhibitorParticipants will ingest a standard dose of SGLT2i prescribed by the standard of care physician. | Drug | Group 1 |
Primary outcome
Change in serum klotho levels at 6 weeks
Time frame: Baseline, 6 weeks
Change in serum klotho levels in participants with advanced Diabetic Kidney Disease (DKD) at 6 weeks are measured by immunoprecipitation-immunoblot.
Change in serum klotho levels at 12 week
Time frame: Baseline, 12 weeks
Change in Serum klotho levels in participants with advanced Diabetic Kidney Disease (DKD) at 12 weeks are measured by immunoprecipitation-immunoblot.
2 secondary outcomes
Change in serum magnesium levels at 6 weeks
Time frame: Baseline, 6 weeks
Change in serum magnesium levels at 12 weeks
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Robert Toto, MD principal investigator
University of Texas Southwestern Medical Center
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 Kidney Disease, Chronic and Diabetes, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 9 inclusion and 16 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: finished, as of the sponsor's last update on 12 Aug 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in serum klotho levels at 6 weeks (time frame: Baseline, 6 weeks). The study lists 2 primary outcomes in all. 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 12 Aug 2025.