Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 12:38 AM
NCT ID:
NCT05710367
Eligibility Criteria:
Inclusion Criteria
* Age: 18-70 years
* Patients with genetically confirmed Fabry disease.
* On treatment with Enzyme Replacement Therapy (ERT).
* ERT or chaperone therapy at stable dose for at least 3 last months
* Albuminuria \>35 mg/day and/or proteinuria \>150 mg/day
* eGFR ≥25 mL/min/1.73 m2
* On a stable dose of an ACEi, ARB or renin receptors blockers for at least 4 weeks prior to randomization
* Sufficient command of German language.
* Signed and dated informed consent.
* Known cardiac association of FD
Exclusion Criteria:
* Known hypersensitivity, allergy or contraindications to dapagliflozin.
* Diagnosis of type 1 or type 2 diabetes mellitus
* Patients with any disease (other than Fabry disease) affecting the heart and the kidnys.
* History of kidney transplantation.
* Active malignancy.
* Use of the co-interventional treatments (Aldosterone antagonists, Continuous use of NSAIDs or systemic steroids) within 6 weeks of screening will not be allowed.
* Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following:
1. History of active inflammatory bowel disease within the last six months;
2. Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection;
3. Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months;
4. Pancreatic injury or pancreatitis within the last six months;
5. Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt;
* Subject who, in the assessment of the investigator, may be at risk for dehydration or volume depletion that may affect the interpretation of efficacy or safety data.
* Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing.
* Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
* Women who are pregnant or breast feeding; intention to become pregnant during the course of the study, lack of safe contraception.
* Patients with known or suspected non-compliance, drug or alcohol abuse, including Marijuana cigarettes.
* Participation in another study with investigational drugs within the 30 days preceding and during the present study.
* Enrolment of the investigator, his/her family members, employees and other dependent persons.
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05710367
Study Brief:
Protocol Section:
NCT05710367