NCT05179668CompletedPhase 2
SGLT2 Inhibition in Hemodialysis
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
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
Dapagliflozin will be compared with placebo to evaluate its effects on cardiac structure and safety in patients with kidney failure receiving maintenance hemodialysis.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 220 (actual)
- First submitted
- 16 Dec 2021
- Start date
- 1 Oct 2022
- Primary completion date
- 11 Jul 2025
- Lead sponsor
- Medical University of Vienna
- Diseases
- Chronic kidney disease, Type 2 diabetes
- NCT number
- NCT05179668
- EU CT number
- 2024-518591-31-00
- EudraCT number
- 2021-000733-14
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 220
- From 1 Oct 2022 to the primary completion date, 11 Jul 2025
- 9 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with SGLT2i within the last 6 months
- Scheduled kidney transplant from a living donor
Other illness
- Hypersensitivity or Intolerance of SGLT2 inhibitors
- History of Type 1 diabetes mellitus
- History of diabetic ketoacidosis
- Acute coronary syndrome during the last 30 days
- Severe valvular heart disease
- 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.
Other
- Women of childbearing potential and unwilling or unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment).
- Pregnancy
- Breast feeding
- Substance abuse
- Life expectancy \< 1 year
Who the study is looking for
- Age ≥18 years
- Maintenance hemodialysis 3×/week for ≥ 3 months and ≤5 years
- BMI \<45 kg/m2 and stable weight (±5 kg \["dry weight"\]) over the preceding three months
- Interventricular septum width \>11 mm
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dialyseinstitut Dr. Waller Coordinator of this site? Confirm its status | Feldbach | Austria | Not yet recruiting |
| Dialyseinstitut Gießauf GmbH Coordinator of this site? Confirm its status | Graz | Austria | Not yet recruiting |
| Hanusch Krankenhaus der Wiener Gebietskrankenkasse Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| Klinik Hietzing Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| Medical University of Vienna Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| Klinik Landstrabe Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| Klinik Donaustadt Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| Klinik Favoriten Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
| Wiener Dialysezentrum GmbH Coordinator of this site? Confirm its status | Vienna | Austria | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.