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Effects Of Sodium Glucose Cotranspoter 2 Inhibitors On Heart And Kidneys In Fabry Disease Patients

NCT05710367 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2023-02-02

No results posted yet for this study

Summary

The goal of this clinical trial is to test dapagliflizone in Fabry patients. The main questions it aims to answer are:

* Has 10 mg/d of dapagliflozin a positive effect on kidney functions of Fabry patients.
* Has 10 mg/d of dapagliflozin a positive effect on heart functions in Fabry patients.

Participants will be asked to

* Sign an informed consent
* Give a blood and urine samples
* Be subjected to Echocardiography investigation
* Take 10 mg/day Dapagliflizone

Researchers will compare treatment to placebo groups to see if kidneys and heart functions will be improved in the treatment group better more than the placebo group.

Conditions

Interventions

DRUG

Dapagliflozin 10mg Tab

Forxiga® as an add-on treatment in patients with renal and/or cardiac association FD in an exploratory framework.

DRUG

Placebo

matched oral drug. Placebo tablet will have the same color, taste, smell and package as the verum tablet

Sponsors & Collaborators

  • Albina Nowak, MD

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2024-08-31
Completion
2024-08-31

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05710367 on ClinicalTrials.gov