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:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT05179668
Eligibility Criteria:
Inclusion Criteria:
* Age ≥18 years
* Maintenance hemodialysis 3×/week for ≥3 months and ≤3 years
* BMI \<45 kg/m2 and stable weight (± 5 kg \["dry weight"\]) over the preceding three months
* Signed informed consent
Exclusion Criteria:
Study specific:
* Contraindications for MRI
* Hypersensitivity or Intolerance of SGLT2 inhibitors
* Participation in another clinical trial
Medical condition specific:
* History of diabetic ketoacidosis
* Interventricular septum width ≤ 11 mm
* Severe valvular heart disease
* Life expectancy \< 1 year
* Substance abuse
* History of Type 1 diabetes mellitus
* Scheduled kidney transplant from a living donor
* 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.
* Acute coronary syndrome during the last 30 days
* Existing treatments with SGLT2i within the last 6 months
Female specific:
* Child bearing potential \& unwilling / unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment).
* Pregnancy
* Breast feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05179668
Study Brief:
Protocol Section:
NCT05179668