Trials / Completed
CompletedNCT05179668
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 220 (actual)
- Sponsor
- Medical University of Vienna · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Kidney Failure
- Hemodialysis
- Diabetes Mellitus, Type 2
- Chronic Kidney Disease
- Left Ventricular Hypertrophy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Dapagliflozin 10 MG | administered orally once daily |
| DRUG | Placebo | administered orally once daily |
Timeline
- Start date
- 2022-10-01
- Primary completion
- 2025-07-11
- Completion
- 2026-02-28
- First posted
- 2022-01-05
- Last updated
- 2026-03-03
Locations
9 sites across 1 country: Austria
Source: ClinicalTrials.gov record NCT05179668. Inclusion in this directory is not an endorsement.