Outcome Measures: |
Primary: Primary endpoint, Change from baseline urine albumin to creatinine ratio (UACR) after 48 weeks, 48 weeks | Secondary: Key secondary efficacy endpoint, Change from baseline estimated glomerular filtration rate (eGFR) after 52 weeks (4 weeks off treatment), 52 weeks|Key secondary safety endpoint, Adverse events (including serious adverse events), 52 weeks|Adverse events (AE) of special interest, (a) Ketoacidosis or symptomatic hypoglycemic event., 52 weeks|Adverse events (AE) of special interest, (b) Hyperkalemia (potassium levels ≥15% of the upper normal limit), 52 weeks|Adverse events (AE) of special interest, (c) Decline in eGFR of ≥ 30% relative from baseline eGFR., 52 weeks
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Locations: |
Universitätsklinikum Heidelberg - Children, Heidelberg, Baden-Württenberg, 69120, Germany|LMU Klinikum, München, Bayern, 80336, Germany|v. Haunersches Kinderhospital, München, Bayern, 81337, Germany|Clementine Kinderhospital, Frankfurt, Hessen, 60316, Germany|University Medicine Goettingen - Adults, Göttingen, Lower Saxony, 37075, Germany|University Medicine Goettingen - Childrens Hospital, Göttingen, Lower Saxony, 37075, Germany|Universitätsklinik Köln - Adults, Köln, Nordrhein-Westfalen, 50937, Germany|Universitätsklinik Köln - Children, Köln, Nordrhein-Westfalen, 50937, Germany|Universitätsklinik Münster - Adults, Münster, Nordrhein-Westfalen, 48149, Germany|Universitätsklinikum Münster - Children, Münster, Nordrhein-Westfalen, 48149, Germany|Universitätsklinik Leipzig - Children, Leipzig, Sachsen, 04103, Germany|Universitätsklinikum Leipzig - Adults, Leipzig, Sachsen, 04103, Germany|Charite Berlin - Adults, Berlin, 10117, Germany|Charite Berlin - Children, Berlin, 10117, Germany|Universitätsklinikum Hamburg-Eppendorf - Adults, Hamburg, 20246, Germany|Universitätsklinikum Hamburg-Eppendorf - Children, Hamburg, 20251, Germany
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