Clinical trial • Phase II • Cardiology|Nephrology

Dapagliflozin for Chronic kidney disease|Kidney failure|Left ventricular hypertrophy|Hemodialysis

Phase II trial of Dapagliflozin for Chronic kidney disease|Kidney failure|Left ventricular hypertrophy|Hemodialysis.

Overview

Trial Therapeutic Area: Cardiology|Nephrology
Trial Disease: Chronic kidney disease|Kidney failure|Left ventricular hypertrophy|Hemodialysis
Trial Stage: Phase II
Drug Modality: Small molecule|Other

Randomised, placebo identical to forxiga 10mg encapsulated in gelatinecapsules (matching placebo control). Phase II trial across 9 sites in Austria.

Randomised: Yes
Comparator: Placebo identical to Forxiga 10mg encapsulated in Gelatinecapsules (matching placebo control).
Target Sample Size: 220
Trial Duration For Participant: 182

Recruits 220 No vulnerable populations selected; participants must provide signed informed consent..

Pregnancy Exclusion: o Pregnancy
Vulnerable Population: No vulnerable populations selected; participants must provide signed informed consent.

{"criterion_text":"- •\tAge ≥18 years"}
{"criterion_text":"- •\tMaintenance hemodialysis 3×/week for ≥ 3 months and ≤5 years"}
{"criterion_text":"- •\tBMI < 45 kg/m2 and stable weight (± 5 kg) over the preceding three months"}
{"criterion_text":"- •\tSigned informed consent"}

{"criterion_text":"- o\tHypersensitivity or Intolerance of SGLT2 inhibitors"}
{"criterion_text":"- o\tParticipation in another clinical trial"}
{"criterion_text":"- o\tHistory of diabetic ketoacidosis"}
{"criterion_text":"- o\tLife expectancy < 1 year"}
{"criterion_text":"- o\tInterventricular septum width ≤ 11 mm"}
{"criterion_text":"- o\tSevere valvular heart disease"}
{"criterion_text":"- o\tSubstance abuse"}
{"criterion_text":"- o\tHistory of Type 1 diabetes mellitus"}
{"criterion_text":"- o\tScheduled kidney transplant from a living donor"}
{"criterion_text":"- o\tSGLT2i within the last 6 months"}
{"criterion_text":"- o\tOther significant disease or pathology, that might predispose that patient to an unacceptable risk or interferes with the study in the opinion of the investigator."}
{"criterion_text":"- o\tAcute coronary syndrome during the last 30 days"}
{"criterion_text":"- o\tChild bearing potential & unwilling / unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment)."}
{"criterion_text":"- o\tPregnancy"}
{"criterion_text":"- o\tBreast feeding"}

{"endpoint_text":"- change in Left Ventricular Mass indexed to body surface area (LVMI [g/m²]) from baseline to 6 months","definition_or_measurement_approach":"Change in left ventricular mass indexed to body surface area (LVMI in g/m²) from baseline to 6 months."}

{"endpoint_text":"- 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","definition_or_measurement_approach":"Multiple biochemical, echocardiographic, clinical and quality-of-life measures as listed; specific measurement methods not detailed in the CTIS record."}

Planned Sample Size: 220
Recruitment Window Months: 6
Consent Approach: Signed informed consent required from each participant; subject information and informed consent form documents are available. No assent or proxy consent procedures for minors are specified (participants must be ≥18 years).

Site Name: Medical University Of Vienna
Department Name: Department of Medicine III Division of Nephrology and Dialysis
Contact Person Name: Manfred Hecking
Contact Person Email: Manfred.Hecking@meduniwien.ac.at

Investigational Product Name: Forxiga 10 mg film-coated tablets
Active Substance: Dapagliflozin
Modality: Small molecule
Routes Of Administration: Oral
Route: Oral
Authorisation Status: Authorised (EU marketing authorisation EU/1/12/795/008)
Starting Dose: 10 mg
Dose Levels: 10 mg
Frequency: Daily
Maximum Dose: 10 mg

Investigational Product Name: Placebo identical to Forxiga 10mg encapsulated in Gelatinecapsules
Modality: Other

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