SGLT2 lnhibition in Hemodialysis (DAPA-HD)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Medical University Of Vienna

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Decision date (initial)

2024-12-15

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518591-31-00

EudraCT number

2021-000733-14

ClinicalTrials.gov

NCT05179668

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

Comparing Cardiovascular Outcome between SGLT2i and Placebo

Secondary objectives 1

1. Comparing glucometabolic outcome between SGLT2i and Placebo Comparing Quality of Life between SGLT2i and Placebo

Conditions and MedDRA coding

Chronic Kidney Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

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

Exclusion criteria 15

1. o Hypersensitivity or Intolerance of SGLT2 inhibitors
2. o Participation in another clinical trial
3. o History of diabetic ketoacidosis
4. o Life expectancy < 1 year
5. o Interventricular septum width ≤ 11 mm
6. o Severe valvular heart disease
7. o Substance abuse
8. o History of Type 1 diabetes mellitus
9. o Scheduled kidney transplant from a living donor
10. 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.
11. o Acute coronary syndrome during the last 30 days
12. o SGLT2i within the last 6 months
13. o Child bearing potential & unwilling / unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment).
14. o Pregnancy
15. o Breast feeding

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 1

1. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Medical University Of Vienna

Sponsor organisation

Medical University Of Vienna

Address

Spitalgasse 23, Alsergrund Alsergrund

City

Vienna

Postcode

1090

Country

Austria

Scientific contact point

Organisation

Medical University Of Vienna

Contact name

Department of Medicine III Division of Nephrology and Dialysis

Public contact point

Organisation

Medical University Of Vienna

Contact name

Department of Medicine III Division of Nephrology and Dialysis

Locations

1 EU/EEA country · 9 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications