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

The University of Texas System (UT)

Status and phase

Active, not recruiting

Phase 1

Conditions

Diabetes

Kidney Disease, Chronic

Treatments

Drug: SGLT2 inhibitor

Study type

Observational

Funder types

Other

Identifiers

NCT05033054

STU-2021-0492

Details and patient eligibility

About

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

Enrollment

28 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)
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.

Exclusion criteria

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
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