Skip to content

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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518591-31-00
Enrollment
220
Registered
2024-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Hemodialysis, Kidney Failure, Left Ventricular Hypertrophy

Brief summary

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

Detailed description

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

Interventions

DRUGForxiga 10 mg film-coated tablets
DRUGPlacebo identical to Forxiga 10mg encapsulated in Gelatinecapsules

Sponsors

Medical University Of Vienna
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Austria

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026