Kidney FailurePhase 2DAPA-HDNCT05179668
SGLT2 Inhibition in Hemodialysis
A Phase 2 study testing Dapagliflozin 10 MG in people with Kidney Failure and Hemodialysis, run by Medical University of Vienna at 9 sites in Austria.
Trial summary
Dapagliflozin will be compared with placebo to evaluate its effects on cardiac structure and safety in patients with kidney failure receiving maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Hemodialysis, Diabetes Mellitus, Type 2
- What is being tested?
- Dapagliflozin 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 220 participants
- Where
- 9 sitesAustria
- Study dates
- 1 Oct 2022to 28 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Treatment with SGLT2i within the last 6 months
- Hypersensitivity or Intolerance of SGLT2 inhibitors
- History of Type 1 diabetes mellitus
- History of diabetic ketoacidosis
- Scheduled kidney transplant from a living donor
- Acute coronary syndrome during the last 30 days
Show all 13Show fewer
- Severe valvular heart disease
- 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
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Austria9 sites
Dialyseinstitut Dr. Waller
Feldbach, 8330
Dialyseinstitut Gießauf GmbH
Graz
Klinik Landstraße
Vienna, 1030
Medical University of Vienna
Vienna, 1090
Klinik Favoriten
Vienna, 1100
Krankenhaus Hietzing
Vienna, 1130
Hanusch Krankenhaus
Vienna, 1140
Klinik Donaustadt
Vienna, 1220
Wiener Dialysezentrum
Vienna, 1220
About this study
Official title: 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
Dapagliflozin will be compared with placebo to evaluate its effects on cardiac structure and safety in patients with kidney failure receiving maintenance hemodialysis.
Read the detailed description
The Dapagliflozin in Hemodialysis (DAPA-HD) trial is an academic, multicenter, randomized, double-blind, placebo-controlled phase 2 study designed to assess the cardiovascular effects of dapagliflozin in patients with kidney failure undergoing maintenance hemodialysis. A total of 220 patients are randomized 1:1 to dapagliflozin 10 mg once daily or matching placebo for six months, with stratification according to residual urine output. The primary endpoint is the change in left ventricular mass indexed to body surface area, assessed by transthoracic echocardiography after six months of treatment. Secondary endpoints include additional echocardiographic measures, biomarker changes, quality of life, clinical events, and safety outcomes.
- Conditions
- Kidney Failure, Hemodialysis, Diabetes Mellitus, Type 2, Chronic Kidney Disease, Left Ventricular Hypertrophy
- Being tested
- Dapagliflozin 10 MG, Placebo
- Keywords
- Dapagliflozin, SGLT2 inhibition
- Medical subject headings
- Renal Insufficiency, Diabetes Mellitus, Type 2, Renal Insufficiency, Chronic, Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dapagliflozin 10 MGDrug
Also called Forxiga 10 MG
administered orally once daily
PlaceboDrug
administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Dapagliflozin 10 mg | Experimental | Not described Receives: Drug: Dapagliflozin 10 MG |
| Placebo tablet | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in left ventricular mass indexed to body surface area
Change in left ventricular mass indexed to body surface area using echocardiography
Measured: 6 months
Secondary outcomes (10)
Change in left ventricular mass indexed to body height assessed by echocardiography
Measured: 6 months
Change in LVEF assessed by echocardiography
Measured: 6 months
Change in in LA volume index assessed by echocardiography
Measured: 6 months
Change in in GLS assessed by echocardiography
Measured: 6 months
Change in in Cardiac Biomarkers (NT-proBNP, hsTnT)
Measured: 6 months
Change in health-related quality of life
Measured: 6 months
Change in LV end-diastolic volume assessed by echocardiography
Measured: 6 months
Change in LV end-systolic volume assessed by echocardiography
Measured: 6 months
Change in body weight
Measured: 6 months
Change in blood pressure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Oct 2022
- Primary completion11 Jul 2025
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Dr. Manfred Hecking, MD PhD, Medical University of Vienna
- Investigators
- Manfred Hecking, MD, PhD, Principal investigator, Medical University of Vienna, Department of Medicine III, Division of Nephrology and DialysisThomas A Zelniker, MD, MSc, Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179668
- Sponsor's protocol ID
- EK-Nr.: 1196/2021
- Other IDs
- 2021-000733-14
- Acronym
- DAPA-HD
- Status last verified
- Feb 2026
- First submitted
- 16 Dec 2021
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05179668
- Acronym / sponsor ID
- DAPA-HD / EK-Nr.: 1196/2021
- Conditions
- Kidney Failure, Hemodialysis, Diabetes Mellitus, Type 2, Chronic Kidney Disease, Left Ventricular Hypertrophy
- Keywords
- Dapagliflozin, SGLT2 inhibition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 5 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dapagliflozin will be compared with placebo to evaluate its effects on cardiac structure and safety in patients with kidney failure receiving maintenance hemodialysis.
Detailed description
The Dapagliflozin in Hemodialysis (DAPA-HD) trial is an academic, multicenter, randomized, double-blind, placebo-controlled phase 2 study designed to assess the cardiovascular effects of dapagliflozin in patients with kidney failure undergoing maintenance hemodialysis. A total of 220 patients are randomized 1:1 to dapagliflozin 10 mg once daily or matching placebo for six months, with stratification according to residual urine output. The primary endpoint is the change in left ventricular mass indexed to body surface area, assessed by transthoracic echocardiography after six months of treatment. Secondary endpoints include additional echocardiographic measures, biomarker changes, quality of life, clinical events, and safety outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dapagliflozin 10 mg | Experimental | Drug: Dapagliflozin 10 MG |
| Placebo tablet | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- Treatment with SGLT2i within the last 6 months
- Hypersensitivity or Intolerance of SGLT2 inhibitors
- History of Type 1 diabetes mellitus
- History of diabetic ketoacidosis
- Scheduled kidney transplant from a living donor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dapagliflozin 10 MGAlso: Forxiga 10 MGadministered orally once daily | Drug | Dapagliflozin 10 mg |
| Placeboadministered orally once daily | Drug | Placebo tablet |
Primary outcome
Change in left ventricular mass indexed to body surface area
Time frame: 6 months
Change in left ventricular mass indexed to body surface area using echocardiography
10 secondary outcomes
Change in left ventricular mass indexed to body height assessed by echocardiography
Time frame: 6 months
Change in LVEF assessed by echocardiography
Time frame: 6 months
Change in in LA volume index assessed by echocardiography
Time frame: 6 months
Change in in GLS assessed by echocardiography
Time frame: 6 months
Change in in Cardiac Biomarkers (NT-proBNP, hsTnT)
Time frame: 6 months
Change in health-related quality of life
Time frame: 6 months
Change in LV end-diastolic volume assessed by echocardiography
Time frame: 6 months
Change in LV end-systolic volume assessed by echocardiography
Time frame: 6 months
Change in body weight
Time frame: 6 months
Change in blood pressure
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Hecking, MD, PhD principal investigator
Medical University of Vienna, Department of Medicine III, Division of Nephrology and Dialysis
Thomas A Zelniker, MD, MSc principal investigator
Medical University of Vienna
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dapagliflozin 10 MG in people with Kidney Failure and Hemodialysis, run by Medical University of Vienna at 9 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in left ventricular mass indexed to body surface area (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.