NCT05179668

Brief Summary

Dapagliflozin will be compared with placebo to evaluate its effects on cardiac structure and safety in patients with kidney failure receiving maintenance hemodialysis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2022

Typical duration for phase_2

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

October 1, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 11, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2026

Completed
Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

2.8 years

First QC Date

December 16, 2021

Last Update Submit

February 28, 2026

Conditions

Kidney FailureHemodialysisDiabetes Mellitus, Type 2Chronic Kidney DiseaseLeft Ventricular Hypertrophy

Keywords

DapagliflozinSGLT2 inhibition

Outcome Measures

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

    6 months

Secondary Outcomes (10)

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

    6 months

  • Change in LVEF assessed by echocardiography

    6 months

  • Change in in LA volume index assessed by echocardiography

    6 months

  • Change in in GLS assessed by echocardiography

    6 months

  • Change in in Cardiac Biomarkers (NT-proBNP, hsTnT)

    6 months

  • +5 more secondary outcomes

Study Arms (2)

Dapagliflozin 10 mg

EXPERIMENTAL
Drug: Dapagliflozin 10 MG

Placebo tablet

PLACEBO COMPARATOR
Drug: Placebo

Interventions

PlaceboDRUG

administered orally once daily

Placebo tablet
Dapagliflozin 10 MGDRUG

administered orally once daily

Also known as: Forxiga 10 MG
Dapagliflozin 10 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Dialyseinstitut Dr. Waller

Feldbach, 8330, Austria

Location

Dialyseinstitut Gießauf GmbH

Graz, Austria

Location

Klinik Landstraße

Vienna, 1030, Austria

Location

Medical University of Vienna

Vienna, 1090, Austria

Location

Klinik Favoriten

Vienna, 1100, Austria

Location

Krankenhaus Hietzing

Vienna, 1130, Austria

Location

Hanusch Krankenhaus

Vienna, 1140, Austria

Location

Klinik Donaustadt

Vienna, 1220, Austria

Location

Wiener Dialysezentrum

Vienna, 1220, Austria

Location

MeSH Terms

Conditions

Renal InsufficiencyDiabetes Mellitus, Type 2Renal Insufficiency, ChronicHypertrophy, Left Ventricular

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, Anatomical

Study Officials

  • Manfred Hecking, MD, PhD

    Medical University of Vienna, Department of Medicine III, Division of Nephrology and Dialysis

    PRINCIPAL INVESTIGATOR

  • Thomas A Zelniker, MD, MSc

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 16, 2021

First Posted

January 5, 2022

Study Start

October 1, 2022

Primary Completion

July 11, 2025

Study Completion

February 28, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(9)