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

Sponsor
Albina Nowak, MD
Study ID
NCT05710367
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    Forxiga® as an add-on treatment in patients with renal and/or cardiac association FD in an exploratory framework.
  • Placebo — DRUG
    matched oral drug. Placebo tablet will have the same color, taste, smell and package as the verum tablet

Study Details

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.

Key Dates

Start date
Aug 31, 2023
Status verified
Jan 2023
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin 10mg Tab
    SGLT2is- Dapagliflozin (Forxiga): 10 mg/d, oral drug
  • Placebo Comparator: Placebo
    Placebo tablet will have the same color, taste, smell and package as the verum tablet

Primary Outcome Measure

Assess the change of eGFR in treatment months 6, 12 and at baseline [ Time Frame: Baseline, 6 months and 12 months ]

Central Contacts

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