ClinicalTrials.gg
CompletedNCT05179668DAPA-HDUpdated Mar 3, 2026

SGLT2 Inhibition in Hemodialysis

A Phase 2 interventional study of Dapagliflozin 10 MG and Placebo in Kidney Failure, Hemodialysis and Diabetes Mellitus, Type 2, sponsored by Medical University of Vienna. Completed at 9 sites in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-03.

Sponsored by Medical University of Vienna · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
220
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Kidney Failure
  • Hemodialysis
  • Diabetes Mellitus, Type 2
  • Chronic Kidney Disease
  • Left Ventricular Hypertrophy

Keywords

  • Dapagliflozin
  • SGLT2 inhibition
03

In context

Renal Insufficiency

1,409 studies on the registry are indexed under Renal Insufficiency; 143 are open to participants now.

This study's enrollment of 220 is above the median of 40 across 1,058 interventional studies indexed under Renal Insufficiency.

Browse Renal Insufficiency studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,109 studies on the registry; 184 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years
  • Maintenance hemodialysis 3×/week for ≥ 3 months and ≤5 years
  • \<45 kg/m2 and stable weight (±5 kg ["dry weight"]) over the preceding three months
  • Interventricular septum width >11 mm

Exclusion criteria

Exclusion Criteria:

  • Treatment with SGLT2i within the last 6 months
  • 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
  • Severe valvular heart disease
  • Women of 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
  • \< 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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
220 participants (actual)

Study arms

  • Experimental
    Dapagliflozin 10 mg

    Drug: Dapagliflozin 10 MG

  • Placebo comparator
    Placebo tablet

    Drug: Placebo

Interventions

  • administered orally once daily

    Also known as: Forxiga 10 MG

  • DrugPlacebo

    administered orally once daily

06

What researchers measure

Primary outcomes

  1. Change in left ventricular mass indexed to body surface area

    Change in left ventricular mass indexed to body surface area using echocardiography

    Time frame: 6 months

Secondary outcomes

  1. Change in left ventricular mass indexed to body height assessed by echocardiography

    Time frame: 6 months

  2. Change in LVEF assessed by echocardiography

    Time frame: 6 months

  3. Change in in LA volume index assessed by echocardiography

    Time frame: 6 months

  4. Change in in GLS assessed by echocardiography

    Time frame: 6 months

  5. Change in in Cardiac Biomarkers (NT-proBNP, hsTnT)

    Time frame: 6 months

  6. Change in health-related quality of life

    Time frame: 6 months

  7. Change in LV end-diastolic volume assessed by echocardiography

    Time frame: 6 months

  8. Change in LV end-systolic volume assessed by echocardiography

    Time frame: 6 months

  9. Change in body weight

    Time frame: 6 months

  10. Change in blood pressure

    Time frame: 6 months

07

Study locations

9 sites
  • Dialyseinstitut Dr. Waller
    Feldbach, 8330, Austria
  • Dialyseinstitut Gießauf GmbH
    Graz, Austria
  • Klinik Landstraße
    Vienna, 1030, Austria
  • Medical University of Vienna
    Vienna, 1090, Austria
  • Klinik Favoriten
    Vienna, 1100, Austria
  • Krankenhaus Hietzing
    Vienna, 1130, Austria
  • Hanusch Krankenhaus
    Vienna, 1140, Austria
  • Klinik Donaustadt
    Vienna, 1220, Austria
  • Wiener Dialysezentrum
    Vienna, 1220, Austria
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2022 to primary completion in Jul 2025, 33 months.

Of 26 phase 2 interventional studies under Renal Insufficiency, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 34. This study's 33 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 16, 2021
First posted
Jan 5, 2022
StartActual
Oct 1, 2022
Primary completionActual
Jul 11, 2025
CompletionActual
Feb 28, 2026
Last update
Mar 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05179668
Responsible party
Assoc. Prof. Dr. Manfred Hecking, MD PhD (Principal Investigator, Medical University of Vienna) — Principal investigator
First posted
Jan 5, 2022
Start date
Oct 1, 2022
Primary completion
Jul 11, 2025
Completion
Feb 28, 2026
Last update
Mar 3, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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