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

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ClinicalTrials.gov Identifier: NCT05033054
Recruitment Status : Recruiting
First Posted : September 2, 2021
Last Update Posted : January 10, 2023
Sponsor:
Information provided by (Responsible Party):
Robert Toto, University of Texas Southwestern Medical Center

Study Description
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Brief Summary:

This is a prospective, randomized double blind placebo controlled parallel group trial to assess dapagliflozin on surrogate markers of kidney and cardiovascular health in patients with stage 3b-4 Chronic Kidney Disease (CKD).

Randomization:

1) Dapagliflo3)zin 10mg (total dosage per day)

1) Placebo Dapagliflozin daily

This study includes three clinic in person visits and weekly telephone visits for 12 weeks.

  1. Recruit 30 patients with CKD stages 3b-4 and randomize them in double-blind fashion to either placebo or dapagliflozin 10mg daily for 12 weeks
  2. Determine the effect of interventions on the primary outcome variable serum klotho measured by immunoprecipitation-immunoblot

Condition or disease Intervention/treatment Phase
Kidney Disease, Chronic Diabetes Drug: Dapagliflozin 10 mg Other: Placebo Dapagliflozin Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Effect of SGLT2i on Cardiovascular Biomarkers in Patients With Type 2 Diabetes and CKD Stage 3b-4
Actual Study Start Date : November 20, 2022
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Group 1: Dapagliflozin
Group 1 will receive the medication Dapagliflozin10mg (total dosage per day) daily.
 Drug: Dapagliflozin 10 mg
Dapagliflozin tablets containing 10 mg will be administered orally with 8 oz water.
Experimental: Group 2: Placebo Dapagliflozin
Group 2 will receive Placebo Dapaglifozin daily
 Other: Placebo Dapagliflozin
Placebo Dapagliflozin tablets (10 mg) will be administered orally with 8 oz water


Outcome Measures
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Primary Outcome Measures :
  1. 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 12 weeks are measured by immunoprecipitation-immunoblot.

  2. 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 24 weeks are measured by immunoprecipitation-immunoblot.


Secondary Outcome Measures :
  1. Change in serum magnesium levels at 6 weeks [ Time Frame: Baseline, 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.

  2. Change in serum magnesium levels at 12 weeks [ Time Frame: Baseline, 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 dapagliflozin
  • History of persistent hypercalcemia (serum total Calcium > 10.5 mg/dl)
  • Body mass index > 45 kg/m2
  • Intolerance to magnesium supplementation
  • 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 IP, 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05033054


Contacts
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Contact: Robert Toto, MD 214-645-8267 robert.toto@utsouthwestern.edu
Contact: Nancy Wang, Bachelor 214-645-8240 zhengnan.wang@utsouthwestern.edu

Locations
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United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Nancy Wang, Bachelor    214-645-8240    zhengnan.wang@utsouthwestern.edu   
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Robert Toto, MD UT Southwestern Medical Center
More Information
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Responsible Party: Robert Toto, PROFESSOR, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT05033054    
Other Study ID Numbers: STU-2021-0492
First Posted: September 2, 2021    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
 Renal Insufficiency
Dapagliflozin
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs