Skip to main content
MedPathMedPath Home
Clinical Trials/2024-518591-31-00
2024-518591-31-00
Not yet recruiting
Phase 2

SGLT2 INHIBITION (DAPAGLIFLOZIN) IN DIABETIC AND NON-DIABETIC HEMODIALYSIS PATIENTS WITH AND WITHOUT RESIDUAL URINE VOLUME: A PROSPECTIVE RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLINDED PHASE II TRIAL

Medical University Of Vienna9 sites in 1 country220 target enrollmentDecember 15, 2024
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
DrugsPlacebo identical to Forxiga 10mg encapsulated in GelatinecapsulesForxiga 10 mg film-coated tablets

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Medical University Of Vienna
Enrollment
220
Locations
9
Primary Endpoint
change in Left Ventricular Mass indexed to body surface area (LVMI [g/m²]) from baseline to 6 months
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Comparing Cardiovascular Outcome between SGLT2i and Placebo

Registry
euclinicaltrials.eu
Start Date
December 15, 2024
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Department of Medicine III Division of Nephrology and Dialysis

Scientific

Medical University Of Vienna

Eligibility Criteria

Inclusion Criteria

  • •Age ≥18 years
  • •Maintenance hemodialysis 3×/week for ≥ 3 months and ≤5 years
  • •BMI < 45 kg/m2 and stable weight (± 5 kg) over the preceding three months
  • •Signed informed consent

Exclusion Criteria

  • •o Hypersensitivity or Intolerance of SGLT2 inhibitors
  • •o Other significant disease or pathology, that might predispose that patient to an unacceptable risk or interferes with the study in the opinion of the investigator.
  • •o Acute coronary syndrome during the last 30 days
  • •o SGLT2i within the last 6 months
  • •o Child bearing potential & unwilling / unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment).
  • •o Pregnancy
  • •o Breast feeding
  • •o Participation in another clinical trial
  • •o History of diabetic ketoacidosis
  • •o Life expectancy < 1 year

Outcomes

Primary Outcomes

change in Left Ventricular Mass indexed to body surface area (LVMI [g/m²]) from baseline to 6 months

change in Left Ventricular Mass indexed to body surface area (LVMI [g/m²]) from baseline to 6 months

Secondary Outcomes

  • Glucose Insulin C-Peptide Glucagon Glucagon-like Peptide-1 Epinephrine Norepinephrine Cortisol Growth Hormone Lactate Alanine β-hydroxybutyrate (βOHB) HbA1C Left Ventricular Mass (LVM) Left Ventricular Ejection Fraction (EF), Left Ventricular Hypertrophy (LVH) cardiac fibrosis Left Ventricular Mass Index to height(LVMI [m²]) Left Atrial Diameter (LAD [mm]) Blood Pressure (mmHg) Body Weight BMI Predialysis TnT postdialysis TnT proBNP Quality of Life

Study Sites (9)

Loading locations...

Similar Trials

Completed
Not Applicable
Efficacy of SGLT2 inhibitorDiabetic nephropathy
JPRN-UMIN000036183ihon University Itabashi Hospital9
Completed
Phase 4
SGLT2 Inhibition in Patients With Type 2 Diabetes Mellitus and Acute Decompensated Heart Failure: SLIM-AHF Study
JPRN-UMIN000026315Osaka General Medical Center250
Active, not recruiting
Phase 1
Personalized treatment of type 2 diabetes
EUCTR2020-000913-33-SEniversity of gothenburg200
Completed
Phase 3
Dapagliflozin in Physical Exercise in Type 1 DiabetesDiabetes Mellitus, Type 1
NCT04049110Insel Gruppe AG, University Hospital Bern39
Not yet recruiting
Not Applicable
Effect of Dapagliflozin for type 2 diabetes mellitus with fatty liver
JPRN-UMIN000026549Kagawa prefectural central hospital25