Phase
Condition
Focal Segmental Glomerulosclerosis
Treatment
Empagliflozin 25 MG
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed and dated written informed consent.
Patients aged ≥18 years on PD with RKF defined as at least 250 cc of urine outputper day (assessed via 24-hour urine collection) and a minimum measured GFR of 2ml/min/1.73m2, as measured at least once in the last 3 months.
Stable PD prescription, as determined by investigators.
Stable dose of RAAS blockade if on a medication within this class for the last 30days.
Exclusion
Exclusion Criteria:
Type 1 diabetes.
Recent (in the 30 days prior to screening) acute coronary syndrome orcerebrovascular event.
PD peritonitis within 30 days of screening.
History of organ transplant, including pancreas, pancreatic islet cells or kidneytransplant.
Planned surgery/procedures or radiologic investigations requiring contrast duringthe trial.
Pregnant, planning to become pregnant, or nursing an infant during the study period
History of any DKA event
Blood dyscrasias or any disorders causing hemolysis or unstable red blood cells (e.g., malaria, babesiosis, hemolytic anemia) at screening.
Women who are pregnant, nursing, or who plan to become pregnant whilst in the trial.
Alcohol or drug abuse within the 3 months prior to screening that would interferewith trial participation based on Investigator's judgement.
Use of SGLT2 inhibitor within 30 days prior to screening.
Intake of an investigational drug in another trial within 30 days prior toscreening.
Patient not able to understand and comply with study requirements, based onInvestigator's judgment.
Any other clinical condition that, based on Investigator's judgement, wouldjeopardize patient safety during trial participation or would affect the studyoutcome (e.g. immunocompromised patients, active malignancy, patients who might beat higher risk of developing genital or mycotic infections, patients with chronicviral infections, uncontrolled hypertension, cardiorenal and/or hepatorenalsyndrome, severe hepatic impairments etc.).
Study Design
Study Description
Connect with a study center
Toronto General Hospital
Toronto, Ontario M5G2N2
CanadaActive - Recruiting
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