Effect of SGLT2i on Cardiovascular Biomarkers in Patients With Type 2 Diabetes and CKD Stage 3b-4

NCT05033054 | Completed FDA Drug

• 1 other identifier: STU-2021-0492
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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. 1.Recruit 28 patients with CKD stages 3b-4 and follow up for 12 weeks
2. 2.Determine the effect of interventions on the primary outcome variable serum klotho measured by immunoprecipitation-immunoblot

Conditions

Kidney Disease, Chronic; Diabetes

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 12 weeks

Secondary Outcomes (2)

• Change in serum magnesium levels at 6 weeks

  Baseline, 6 weeks

• Change in serum magnesium levels at 12 weeks

  Baseline, 12 weeks

Study Arms (1)

Group 1

Group 1: take prescribed SGLT2i after baseline visit.

Drug: SGLT2 inhibitor

Interventions

SGLT2 inhibitor DRUG

Participants will ingest a standard dose of SGLT2i prescribed by the standard of care physician.

Group 1

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with type 2 diabetes mellitus and stage 3b-4 chronic kidney disease.

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum CPP, Magnesium, creatinine, Klotho, HsCRP, PTH, FSF23. Urine Klotho, creatinine, Ngal,8-isoprostane. 24 hour urine FEMg

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus

Interventions

Sodium-Glucose Transporter 2 Inhibitors

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; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Officials

• Robert Toto, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 2, 2021
• Study Start: January 1, 2022
• Primary Completion: January 2, 2025
• Study Completion: February 1, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)